NCT05460273
Version 12 to 13 · AstraZeneca
Patch inspector
Manual review pending.
None recorded.
[
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"new_type": "ESTIMATED",
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"severity": "high",
"direction": "later",
"new_value": "2025-12-31",
"old_value": "2024-12-30",
"delta_days": 366,
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Confirmed Objective Response Rate(ORR) Assessed by Independent Central Review(ICR)
/protocolSection/outcomesModule/primaryOutcomes/0/description primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. <p>Confirmed ORR assessed by ICR is defined as the proportion of participants in each cohort who have a confirmed complete response(CR) or confirmed partial response(PR), as assessed by ICR per RECIST 1.1.</p><p>The measure of interest is the estimate of confirmed ORR.</p>
Confirmed ORR is defined as the proportion of participants in each cohort who have a confirmed CR or confirmed PR, as assessed by ICR per RECIST 1.1.
/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Up to approximately 36 months
TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.
/protocolSection/outcomesModule/secondaryOutcomes/0/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Confirmed Objective Response Rate(ORR) assessed by investigator
Confirmed Objective Response Rate(ORR) Assessed by Investigator
/protocolSection/outcomesModule/secondaryOutcomes/0/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Confirmed ORR assessed by investigator is defined as the proportion of participants in each cohort who have a confirmed CR or confirmed PR, as determined by investigator assessment per RECIST 1.1.
Confirmed ORR is defined as the proportion of participants in each cohort who have a confirmed CR or confirmed PR, as determined by investigator assessment per RECIST 1.1.
/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Up to approximately 36months
TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.
/protocolSection/outcomesModule/secondaryOutcomes/1/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Duration of Response (DoR)
Duration of Response (DoR), Assessed by Investigator
/protocolSection/outcomesModule/secondaryOutcomes/1/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Duration of response is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression per RECIST 1.1, as assessed by ICR and by investigator, or death due to any cause.
Duration of response is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression per RECIST 1.1, as assessed by investgator, or death due to any cause.
/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Up to approximately 36 months
TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.
/protocolSection/outcomesModule/secondaryOutcomes/2/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Disease Control Rate (DCR)
Disease Control Rate (DCR), Assessed by ICR
/protocolSection/outcomesModule/secondaryOutcomes/2/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Disease control rate is defined as the percentage of participants who have a confirmed CR or PR or who have stable disease (SD) per RECIST 1.1, as assessed by ICR and by investigator.
Disease control rate is defined as the percentage of participants who have a confirmed CR or PR or who have SD per RECIST 1.1, as assessed by ICR
/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Up to approximately 36 months
TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.
/protocolSection/outcomesModule/secondaryOutcomes/3/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Best Overall Response (BoR)
Best Overall Response (BoR) , Assessed by ICR
/protocolSection/outcomesModule/secondaryOutcomes/3/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Best overall response is defined as participant's best confirmed response during their participation in the study, but prior to starting any subsequent anticancer therapy, up until RECIST 1.1-defined PD or the last evaluable assessment in the absence of RECIST 1.1-defined progression. Best overall response will be assessed by ICR and by investigator per RECIST 1.1.
Best overall response is defined as participant's best confirmed response during their participation in the study, but prior to starting any subsequent anticancer therapy, up until RECIST 1.1-defined PD or the last evaluable assessment in the absence of RECIST 1.1-defined progression.
/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Up to approximately 36 months
TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.
/protocolSection/outcomesModule/secondaryOutcomes/4/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Time To Response (TTR)
Time To Response (TTR) , Assessed by ICR
/protocolSection/outcomesModule/secondaryOutcomes/4/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Time to response is defined as the time from the date of the first dose of study intervention until the date of first documented objective response, which is subsequently confirmed per RECIST 1.1, as assessed by ICR and by investigator.
Time to response is defined as the time from the date of the first dose of study intervention until the date of first documented objective response, which is subsequently confirmed per RECIST 1.1
/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Up to approximately 36 months
TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.
/protocolSection/outcomesModule/secondaryOutcomes/5/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Progression-Free Survival (PFS)
Progression-Free Survival (PFS) , Assessed by ICR
/protocolSection/outcomesModule/secondaryOutcomes/5/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Progression-free survival is defined as time from the date of the first dose of study intervention until progression per RECIST 1.1, as assessed by ICR and by investigator, or death due to any cause.
Progression-free survival is defined as time from the date of the first dose of study intervention until progression per RECIST 1.1, as assessed by ICR, or death due to any cause.
/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Up to approximately 36 months
TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.
/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Up to approximately 36 months
TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.
/protocolSection/outcomesModule/secondaryOutcomes/7/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Number of participants with treatment-emergent adverse event(TEAE), adverse event of special interest (AESI) as assessed by CTCAE version 5.0
Progression-Free Survival (PFS) , Assessed by Investigator
/protocolSection/outcomesModule/secondaryOutcomes/7/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Evaluated from first dose to safety follow up visit.
Progression-free survival is defined as time from the date of the first dose of study intervention until progression per RECIST 1.1, as assessed by investigator, or death due to any cause.
/protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Up to approximately 36 months
TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.
/protocolSection/outcomesModule/secondaryOutcomes/8/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Pharmacokinetic Parameter: Time to maximum plasma concentration (Tmax)
Disease Control Rate (DCR), Assessed by Investigator
/protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Cycle 1, Day 1: predose and 30 minutes, 3 hours, 5 hours, and 7 hours postdose and Days 2, 4, 8, and 15; Cycles 2 Day 1:predose Cycle 4 and 8, Day 1: predose and 1 hour postdose (each cycle is 21 days)
TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.
/protocolSection/outcomesModule/secondaryOutcomes/8/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Duration of response is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression per RECIST 1.1, as assessed by investigator, or death due to any cause.
/protocolSection/outcomesModule/secondaryOutcomes/9/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Immunogenicity of Dato-DXd
Best Overall Response (BoR) , Assessed by Investigator
/protocolSection/outcomesModule/secondaryOutcomes/9/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. The presence of ADAs against Dato-DXd will be evaluated. Titre will be determined when ADA is positive.
Best overall response is defined as participant's best confirmed response during their participation in the study, but prior to starting any subsequent anticancer therapy, up until RECIST 1.1-defined PD or the last evaluable assessment in the absence of RECIST 1.1-defined progression.
/protocolSection/outcomesModule/secondaryOutcomes/9/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Up to approximately 36 months
TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.
/protocolSection/outcomesModule/secondaryOutcomes/10/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Pharmacokinetic Parameter: Area under the plasma concentration- time curve (AUC)
Time To Response (TTR) , Assessed by Investigator
/protocolSection/outcomesModule/secondaryOutcomes/10/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Cycle 1, Day 1: predose and 30 minutes, 3 hours, 5 hours, and 7 hours postdose and Days 2, 4, 8, and 15; Cycles 2 Day 1 predose; Cycle 4 and 8, Day 1: predose and 1 hour postdose (each cycle is 21 days)
TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.
/protocolSection/outcomesModule/secondaryOutcomes/10/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Time to response is defined as the time from the date of the first dose of study intervention until the date of first documented objective response, which is subsequently confirmed per RECIST 1.1.
/protocolSection/outcomesModule/secondaryOutcomes/11/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Pharmacokinetic Parameter: Maximum plasma concentration (Cmax)
Pharmacokinetic Parameter: Area Under the Plasma Concentration- Time Curve (AUC) _ Total Anti-TROP2 Antibody
/protocolSection/outcomesModule/secondaryOutcomes/11/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Cycle 1, Day 1: predose and 30 minutes, 3 hours, 5 hours, and 7 hours postdose and Days 2, 4, 8, and 15; Cycles 2 Day 1:predose Cycle 4 and 8, Day 1: predose and 1 hour postdose (each cycle is 21 days)
TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.
/protocolSection/outcomesModule/secondaryOutcomes/11/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. PK parameters of Total Anti-TROP2 Antibody_Area under the curve
/protocolSection/outcomesModule/secondaryOutcomes/12/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Percentage of participants with TEAEs, AESIs as assessed by CTCAE version 5.0
Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) _ Total Anti-TROP2 Antibody
/protocolSection/outcomesModule/secondaryOutcomes/12/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Evaluated from first dose to safety follow up visit.
PK parameters of Total Anti-TROP2 Antibody_Maximum observed concentration
/protocolSection/outcomesModule/secondaryOutcomes/12/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Up to approximately 36 months
TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.
/protocolSection/outcomesModule/secondaryOutcomes/13 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Pharmacokinetic Parameter: Area Under the Plasma Concentration- Time Curve (AUC) _Dato-DXd",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "PK parameters of Dato-DXd_Area under the curve"
} /protocolSection/outcomesModule/secondaryOutcomes/14 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) _ Dato-DXd",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "PK parameters of Dato-DXd_Maximum observed concentration"
} /protocolSection/outcomesModule/secondaryOutcomes/15 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Pharmacokinetic Parameter: Area Under the Plasma Concentration- Time Curve (AUC) _ MAAA-1181a",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "PK parameters of MAAA-1181a_Area under the curve"
} /protocolSection/outcomesModule/secondaryOutcomes/16 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) _ MAAA-1181a",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "PK parameters of MAAA-1181a_Maximum observed concentration"
} /protocolSection/outcomesModule/secondaryOutcomes/17 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Pharmacokinetic Parameter: Time to Maximum Plasma Concentration (Tmax) _Total Anti-TROP2 Antibody",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "PK parameters of Total Anti-TROP2 Antibody_Time to maximum plasma concentration"
} /protocolSection/outcomesModule/secondaryOutcomes/18 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Pharmacokinetic Parameter: Time to Maximum Plasma Concentration (Tmax) _Dato-DXd",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "Time to maximum plasma concentration"
} /protocolSection/outcomesModule/secondaryOutcomes/19 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Pharmacokinetic Parameter: Time to Maximum Plasma Concentration (Tmax) _ MAAA-1181a",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "PK parameters of MAAA-1181a_Time to maximum plasma concentration"
} /protocolSection/outcomesModule/secondaryOutcomes/20 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Immunogenicity of Dato-DXd",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "The prevalence of ADA (positive at any visit)"
} /protocolSection/outcomesModule/secondaryOutcomes/21 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Duration of Response (DoR), Assessed by ICR",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "Duration of response is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression per RECIST 1.1, as assessed by ICR, or death due to any cause."
} /protocolSection/statusModule/completionDateStruct/date completion_timeline_change Completion date changes are operational timeline signals. 2024-12-30
2025-12-31
/protocolSection/contactsLocationsModule/locations/3/zip 233060
233004
/protocolSection/statusModule/statusVerifiedDate 2024-08
2025-05
/protocolSection/statusModule/lastUpdateSubmitDate 2024-09-20
2025-06-12
/protocolSection/statusModule/lastUpdatePostDateStruct/date 2024-09-23
2025-06-13
/protocolSection/statusModule/resultsFirstSubmitDate 2024-10-31
/protocolSection/statusModule/resultsFirstSubmitQcDate 2025-06-12
/protocolSection/statusModule/resultsFirstPostDateStruct {
"date": "2025-06-13",
"type": "ACTUAL"
} /protocolSection/outcomesModule/otherOutcomes [
{
"measure": "TROP Protein Expression Level",
"timeFrame": "Tumor samples collected before first dose of study intervention",
"description": "Expression of TROP2 will be measured in tumour samples."
}
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{
"date": "2024-10-31",
"type": "RELEASE"
},
{
"date": "2024-12-16",
"type": "RESET"
},
{
"date": "2025-03-06",
"type": "RELEASE"
},
{
"date": "2025-03-25",
"type": "RESET"
},
{
"date": "2025-04-22",
"type": "RELEASE"
},
{
"date": "2025-05-06",
"type": "RESET"
}
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true
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"email": "information.center@astrazeneca.com",
"phone": "1-877-240-9479",
"title": "Global Clinical Lead",
"organization": "AstraZeneca"
},
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"restrictionType": "OTHER",
"piSponsorEmployee": false,
"restrictiveAgreement": true
}
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"timeFrame": "TNBC Cohort: Final analysis occurred 12 months after last participant of this cohort initiated Dato-DXd. NSCLC Cohort: Primary analysis occurred 6 months after last participant of this cohort initiated Dato-DXd.",
"eventGroups": [
{
"id": "EG000",
"title": "Dato-DXd_TNBC",
"description": "Description (Arm-group)",
"otherNumAtRisk": 79,
"deathsNumAtRisk": 79,
"otherNumAffected": 77,
"seriousNumAtRisk": 79,
"deathsNumAffected": 43,
"seriousNumAffected": 13
},
{
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"title": "Dato-DXd_NSCLC",
"description": "Description (Arm-group)",
"otherNumAtRisk": 40,
"deathsNumAtRisk": 40,
"otherNumAffected": 38,
"seriousNumAtRisk": 40,
"deathsNumAffected": 9,
"seriousNumAffected": 10
}
],
"otherEvents": [
{
"term": "Constipation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 79,
"numEvents": 30,
"numAffected": 19
},
{
"groupId": "EG001",
"numAtRisk": 40,
"numEvents": 11,
"numAffected": 9
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 26.1"
},
{
"term": "Dyspepsia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 79,
"numEvents": 4,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 40,
"numEvents": 4,
"numAffected": 2
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 26.1"
},
{
"term": "Mouth ulceration",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 79,
"numEvents": 9,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 40,
"numEvents": 3,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 26.1"
},
{
"term": "Nausea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 79,
"numEvents": 92,
"numAffected": 34
},
{
"groupId": "EG001",
"numAtRisk": 40,
"numEvents": 81,
"numAffected": 24
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 26.1"
},
{
"term": "Stomatitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 79,
"numEvents": 60,
"numAffected": 38
},
{
"groupId": "EG001",
"numAtRisk": 40,
"numEvents": 39,
"numAffected": 23
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 26.1"
},
{
"term": "Vomiting",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 79,
"numEvents": 51,
"numAffected": 23
},
{
"groupId": "EG001",
"numAtRisk": 40,
"numEvents": 34,
"numAffected": 13
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 26.1"
},
{
"term": "Asthenia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 79,
"numEvents": 16,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 40,
"numEvents": 10,
"numAffected": 9
}
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{
"term": "Rash",
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},
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}
],
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{
"term": "Drug-induced liver injury",
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],
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{
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},
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},
{
"term": "Gastrointestinal infection",
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},
{
"term": "Pneumonia bacterial",
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}
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},
{
"term": "Alanine aminotransferase increased",
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{
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},
{
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}
],
"organSystem": "Investigations",
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},
{
"term": "Decreased appetite",
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},
{
"groupId": "EG001",
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],
"organSystem": "Metabolism and nutrition disorders",
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},
{
"term": "Syncope",
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{
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"numAffected": 0
},
{
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}
],
"organSystem": "Nervous system disorders",
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},
{
"term": "Hydronephrosis",
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},
{
"groupId": "EG001",
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"numAffected": 0
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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},
{
"term": "Dyspnoea",
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}
],
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},
{
"term": "Haemoptysis",
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}
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},
{
"term": "Interstitial lung disease",
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"numAffected": 1
},
{
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}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
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},
{
"term": "Pleural effusion",
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{
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"numAffected": 0
},
{
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},
{
"term": "Pneumonitis",
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}
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"organSystem": "Respiratory, thoracic and mediastinal disorders",
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},
{
"term": "Ascites",
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"numAffected": 1
},
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}
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}
],
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"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "Confirmed Objective Response Rate(ORR) Assessed by Independent Central Review(ICR)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "77",
"groupId": "OG000"
},
{
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"groupId": "OG001"
}
]
}
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"groups": [
{
"id": "OG000",
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},
{
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}
],
"classes": [
{
"categories": [
{
"measurements": [
{
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"groupId": "OG000",
"lowerLimit": "23.4",
"upperLimit": "45.4"
},
{
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"groupId": "OG001",
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"upperLimit": "61.5"
}
]
}
]
}
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"unitOfMeasure": "Percentage of participants",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR."
},
{
"type": "SECONDARY",
"title": "Confirmed Objective Response Rate(ORR) Assessed by Investigator",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "77",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
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}
],
"classes": [
{
"categories": [
{
"measurements": [
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"value": "31.2",
"groupId": "OG000",
"lowerLimit": "21.1",
"upperLimit": "42.7"
},
{
"value": "32.5",
"groupId": "OG001",
"lowerLimit": "18.6",
"upperLimit": "49.1"
}
]
}
]
}
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"paramType": "NUMBER",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "Confirmed ORR is defined as the proportion of participants in each cohort who have a confirmed CR or confirmed PR, as determined by investigator assessment per RECIST 1.1.",
"unitOfMeasure": "Percentage of participants",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR."
},
{
"type": "SECONDARY",
"title": "Duration of Response (DoR), Assessed by Investigator",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "25",
"groupId": "OG000"
},
{
"value": "13",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "5.8",
"groupId": "OG000",
"lowerLimit": "4.01",
"upperLimit": "8.4"
},
{
"value": "6.7",
"comment": "The upper limit is not calculable due to insufficient number of participants with events.",
"groupId": "OG001",
"lowerLimit": "4.2",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
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"description": "Duration of response is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression per RECIST 1.1, as assessed by investgator, or death due to any cause.",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "<p>FAS: Enrolled participants who have received at least one dose of treatment.</p><p>The analysis for DOR assessed by investigator was based on the responders in the FAS of each cohort.</p>"
},
{
"type": "SECONDARY",
"title": "Disease Control Rate (DCR), Assessed by ICR",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "77",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "72.7",
"groupId": "OG000",
"lowerLimit": "61.4",
"upperLimit": "82.3"
},
{
"value": "85",
"groupId": "OG001",
"lowerLimit": "70.2",
"upperLimit": "94.3"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "Disease control rate is defined as the percentage of participants who have a confirmed CR or PR or who have SD per RECIST 1.1, as assessed by ICR",
"unitOfMeasure": "Percentage",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR."
},
{
"type": "SECONDARY",
"title": "Best Overall Response (BoR) , Assessed by ICR",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "77",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"title": "Confirmed Partial Response",
"categories": [
{
"measurements": [
{
"value": "33.8",
"groupId": "OG000"
},
{
"value": "45.0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Confirmed Complete Response",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
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"description": "Best overall response is defined as participant's best confirmed response during their participation in the study, but prior to starting any subsequent anticancer therapy, up until RECIST 1.1-defined PD or the last evaluable assessment in the absence of RECIST 1.1-defined progression.",
"unitOfMeasure": "Percentage",
"reportingStatus": "POSTED",
"populationDescription": "RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR."
},
{
"type": "SECONDARY",
"title": "Time To Response (TTR) , Assessed by ICR",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "26",
"groupId": "OG000"
},
{
"value": "18",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "1.5",
"groupId": "OG000",
"lowerLimit": "1.3",
"upperLimit": "2.8"
},
{
"value": "1.4",
"groupId": "OG001",
"lowerLimit": "1.3",
"upperLimit": "2.7"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "Time to response is defined as the time from the date of the first dose of study intervention until the date of first documented objective response, which is subsequently confirmed per RECIST 1.1",
"unitOfMeasure": "Month",
"dispersionType": "Inter-Quartile Range",
"reportingStatus": "POSTED",
"populationDescription": "<p>RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR.</p><p>The analysis for TTR assessed by ICR was based on the responders in the RES of each cohort.</p>"
},
{
"type": "SECONDARY",
"title": "Progression-Free Survival (PFS) , Assessed by ICR",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "79",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "5.3",
"groupId": "OG000",
"lowerLimit": "4.2",
"upperLimit": "6.9"
},
{
"value": "7.4",
"comment": "The upper limit is not calculable due to insufficient number of participants with events.",
"groupId": "OG001",
"lowerLimit": "5.7",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "Progression-free survival is defined as time from the date of the first dose of study intervention until progression per RECIST 1.1, as assessed by ICR, or death due to any cause.",
"unitOfMeasure": "Month",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "FAS: Enrolled participants who have received at least one dose of treatment.\nParticipants who were enrolled but did not subsequently receive study intervention are not included in the analysis."
},
{
"type": "SECONDARY",
"title": "Overall Survival (OS)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "79",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "13.5",
"comment": "The upper limit is not calculable.",
"groupId": "OG000",
"lowerLimit": "10.7",
"upperLimit": "NA"
},
{
"value": "NA",
"comment": "The NAs are not calculable due to insufficient number of participants with events.",
"groupId": "OG001",
"lowerLimit": "NA",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "Overall survival is defined as the time from the date of the first dose of study intervention to the date of death due to any cause.",
"unitOfMeasure": "Month",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "FAS: Enrolled participants who have received at least one dose of treatment.\nParticipants who were enrolled but did not subsequently receive study intervention are not included in the analysis."
},
{
"type": "SECONDARY",
"title": "Progression-Free Survival (PFS) , Assessed by Investigator",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "79",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "4.3",
"groupId": "OG000",
"lowerLimit": "4.0",
"upperLimit": "5.6"
},
{
"value": "7.0",
"groupId": "OG001",
"lowerLimit": "5.5",
"upperLimit": "8.5"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "Progression-free survival is defined as time from the date of the first dose of study intervention until progression per RECIST 1.1, as assessed by investigator, or death due to any cause.",
"unitOfMeasure": "Month",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "FAS: Enrolled participants who have received at least one dose of treatment.\nParticipants who were enrolled but did not subsequently receive study intervention are not included in the analysis."
},
{
"type": "SECONDARY",
"title": "Disease Control Rate (DCR), Assessed by Investigator",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "77",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "76.6",
"groupId": "OG000",
"lowerLimit": "65.6",
"upperLimit": "85.5"
},
{
"value": "85.0",
"groupId": "OG001",
"lowerLimit": "70.2",
"upperLimit": "94.3"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "Duration of response is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression per RECIST 1.1, as assessed by investigator, or death due to any cause.",
"unitOfMeasure": "Percentage",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR."
},
{
"type": "SECONDARY",
"title": "Best Overall Response (BoR) , Assessed by Investigator",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "77",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"title": "Confirmed complete response",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Confirmed partial response",
"categories": [
{
"measurements": [
{
"value": "31.2",
"groupId": "OG000"
},
{
"value": "37.5",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "Best overall response is defined as participant's best confirmed response during their participation in the study, but prior to starting any subsequent anticancer therapy, up until RECIST 1.1-defined PD or the last evaluable assessment in the absence of RECIST 1.1-defined progression.",
"unitOfMeasure": "Percentage",
"reportingStatus": "POSTED",
"populationDescription": "RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR."
},
{
"type": "SECONDARY",
"title": "Time To Response (TTR) , Assessed by Investigator",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "25",
"groupId": "OG000"
},
{
"value": "13",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "1.4",
"groupId": "OG000",
"lowerLimit": "1.4",
"upperLimit": "1.6"
},
{
"value": "1.4",
"groupId": "OG001",
"lowerLimit": "1.3",
"upperLimit": "1.4"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "Time to response is defined as the time from the date of the first dose of study intervention until the date of first documented objective response, which is subsequently confirmed per RECIST 1.1.",
"unitOfMeasure": "Month",
"dispersionType": "Inter-Quartile Range",
"reportingStatus": "POSTED",
"populationDescription": "<p>FAS: Enrolled participants who have received at least one dose of treatment.\nParticipants who were enrolled but did not subsequently receive study intervention are not included in the analysis.</p><p>The analysis for TTR assessed by investigator was based on the responders in the FAS of each cohort.</p>"
},
{
"type": "SECONDARY",
"title": "Pharmacokinetic Parameter: Area Under the Plasma Concentration- Time Curve (AUC) _ Total Anti-TROP2 Antibody",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "9",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "713.9",
"spread": "25.45",
"groupId": "OG000"
},
{
"value": "569.3",
"spread": "24.47",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "GEOMETRIC_MEAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "PK parameters of Total Anti-TROP2 Antibody_Area under the curve",
"unitOfMeasure": "day*ug/mL",
"dispersionType": "Geometric Coefficient of Variation",
"reportingStatus": "POSTED",
"populationDescription": "<p>PK analysis set:Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd.</p><p>The analysis for AUC was based on the patients with intensive PK collection of each cohort.</p>"
},
{
"type": "SECONDARY",
"title": "Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) _ Total Anti-TROP2 Antibody",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "79",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "137.8",
"spread": "19.09",
"groupId": "OG000"
},
{
"value": "121.1",
"spread": "22.38",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "GEOMETRIC_MEAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "PK parameters of Total Anti-TROP2 Antibody_Maximum observed concentration",
"unitOfMeasure": "ug/mL",
"dispersionType": "Geometric Coefficient of Variation",
"reportingStatus": "POSTED",
"populationDescription": "PK analysis set:Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd."
},
{
"type": "SECONDARY",
"title": "Pharmacokinetic Parameter: Area Under the Plasma Concentration- Time Curve (AUC) _Dato-DXd",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "9",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "668.3",
"spread": "21.11",
"groupId": "OG000"
},
{
"value": "504.5",
"spread": "22.38",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "GEOMETRIC_MEAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "PK parameters of Dato-DXd_Area under the curve",
"unitOfMeasure": "day*ug/mL",
"dispersionType": "Geometric Coefficient of Variation",
"reportingStatus": "POSTED",
"populationDescription": "<p>PK analysis set:Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd.</p><p>The analysis for AUC was based on the patients with intensive PK collection of each cohort.</p>"
},
{
"type": "SECONDARY",
"title": "Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) _ Dato-DXd",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "79",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "136.4",
"spread": "20.18",
"groupId": "OG000"
},
{
"value": "115.4",
"spread": "18.12",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "GEOMETRIC_MEAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "PK parameters of Dato-DXd_Maximum observed concentration",
"unitOfMeasure": "ug/mL",
"dispersionType": "Geometric Coefficient of Variation",
"reportingStatus": "POSTED",
"populationDescription": "PK analysis set:Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd."
},
{
"type": "SECONDARY",
"title": "Pharmacokinetic Parameter: Area Under the Plasma Concentration- Time Curve (AUC) _ MAAA-1181a",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "9",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "17.60",
"spread": "24.64",
"groupId": "OG000"
},
{
"value": "17.66",
"spread": "33.09",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "GEOMETRIC_MEAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "PK parameters of MAAA-1181a_Area under the curve",
"unitOfMeasure": "day*ng/mL",
"dispersionType": "Geometric Coefficient of Variation",
"reportingStatus": "POSTED",
"populationDescription": "<p>PK analysis set:Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd.</p><p>The analysis for AUC was based on the patients with intensive PK collection of each cohort.</p>"
},
{
"type": "SECONDARY",
"title": "Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) _ MAAA-1181a",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "79",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "2.484",
"spread": "45.09",
"groupId": "OG000"
},
{
"value": "2.463",
"spread": "42.31",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "GEOMETRIC_MEAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "PK parameters of MAAA-1181a_Maximum observed concentration",
"unitOfMeasure": "ng/mL",
"dispersionType": "Geometric Coefficient of Variation",
"reportingStatus": "POSTED",
"populationDescription": "PK analysis set:Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd."
},
{
"type": "SECONDARY",
"title": "Pharmacokinetic Parameter: Time to Maximum Plasma Concentration (Tmax) _Total Anti-TROP2 Antibody",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "79",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "2.00",
"groupId": "OG000",
"lowerLimit": "1.40",
"upperLimit": "7.17"
},
{
"value": "1.70",
"groupId": "OG001",
"lowerLimit": "0.90",
"upperLimit": "6.83"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "PK parameters of Total Anti-TROP2 Antibody_Time to maximum plasma concentration",
"unitOfMeasure": "Hour",
"dispersionType": "Full Range",
"reportingStatus": "POSTED",
"populationDescription": "PK analysis set: Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd."
},
{
"type": "SECONDARY",
"title": "Pharmacokinetic Parameter: Time to Maximum Plasma Concentration (Tmax) _Dato-DXd",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "79",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "1.92",
"groupId": "OG000",
"lowerLimit": "1.12",
"upperLimit": "7.17"
},
{
"value": "1.77",
"groupId": "OG001",
"lowerLimit": "0.90",
"upperLimit": "5.22"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "Time to maximum plasma concentration",
"unitOfMeasure": "h",
"dispersionType": "Full Range",
"reportingStatus": "POSTED",
"populationDescription": "PK analysis set: Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd."
},
{
"type": "SECONDARY",
"title": "Pharmacokinetic Parameter: Time to Maximum Plasma Concentration (Tmax) _ MAAA-1181a",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "79",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "5.00",
"groupId": "OG000",
"lowerLimit": "1.67",
"upperLimit": "24.22"
},
{
"value": "4.98",
"groupId": "OG001",
"lowerLimit": "4.77",
"upperLimit": "25.07"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "PK parameters of MAAA-1181a_Time to maximum plasma concentration",
"unitOfMeasure": "Hour",
"dispersionType": "Full Range",
"reportingStatus": "POSTED",
"populationDescription": "PK analysis set: Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd."
},
{
"type": "SECONDARY",
"title": "Immunogenicity of Dato-DXd",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "75",
"groupId": "OG000"
},
{
"value": "38",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "33.3",
"groupId": "OG000"
},
{
"value": "36.8",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "The prevalence of ADA (positive at any visit)",
"unitOfMeasure": "percentage",
"reportingStatus": "POSTED",
"populationDescription": "ADA Evaluable Set: Participants in the FAS with a non-missing baseline Dato-DXd ADA result and at least one post-baseline Dato-DXd ADA result."
},
{
"type": "SECONDARY",
"title": "Duration of Response (DoR), Assessed by ICR",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "26",
"groupId": "OG000"
},
{
"value": "18",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "6.7",
"groupId": "OG000",
"lowerLimit": "4.53",
"upperLimit": "12.6"
},
{
"value": "8.3",
"comment": "The upper limit is not calculable due to insufficient number of participants with events",
"groupId": "OG001",
"lowerLimit": "5.9",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "Duration of response is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression per RECIST 1.1, as assessed by ICR, or death due to any cause.",
"unitOfMeasure": "Month",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "<p>RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR.</p><p>The analysis for DOR assessed by ICR was based on the responders in the RES of each cohort.</p>"
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "FG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"periods": [
{
"title": "Overall Study",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "79"
},
{
"groupId": "FG001",
"numSubjects": "40"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "29"
},
{
"comment": "NSCLC cohort has not reached final analysis.",
"groupId": "FG001",
"numSubjects": "0"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "50"
},
{
"groupId": "FG001",
"numSubjects": "40"
}
]
}
],
"dropWithdraws": [
{
"type": "Death",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "43"
},
{
"groupId": "FG001",
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"upperLimit": "42.7"
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},
{
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"upperLimit": "8.4"
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{
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{
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"categories": [
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"groupId": "OG000",
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"upperLimit": "82.3"
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"reportingStatus": "POSTED",
"populationDescription": "RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR."
},
{
"type": "SECONDARY",
"title": "Best Overall Response (BoR) , Assessed by ICR",
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{
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{
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],
"classes": [
{
"title": "Confirmed Partial Response",
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"measurements": [
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"groupId": "OG000"
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{
"value": "45.0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Confirmed Complete Response",
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{
"measurements": [
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"value": "0",
"groupId": "OG000"
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{
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},
{
"type": "SECONDARY",
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}
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"groupId": "OG000",
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"upperLimit": "2.8"
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{
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],
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"unitOfMeasure": "Month",
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"reportingStatus": "POSTED",
"populationDescription": "<p>RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR.</p><p>The analysis for TTR assessed by ICR was based on the responders in the RES of each cohort.</p>"
},
{
"type": "SECONDARY",
"title": "Progression-Free Survival (PFS) , Assessed by ICR",
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"units": "Participants",
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"value": "79",
"groupId": "OG000"
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{
"value": "40",
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]
}
],
"groups": [
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"id": "OG000",
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"id": "OG001",
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],
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"categories": [
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"groupId": "OG000",
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"upperLimit": "6.9"
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{
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"comment": "The upper limit is not calculable due to insufficient number of participants with events.",
"groupId": "OG001",
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]
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}
],
"paramType": "MEDIAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "Progression-free survival is defined as time from the date of the first dose of study intervention until progression per RECIST 1.1, as assessed by ICR, or death due to any cause.",
"unitOfMeasure": "Month",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "FAS: Enrolled participants who have received at least one dose of treatment.\nParticipants who were enrolled but did not subsequently receive study intervention are not included in the analysis."
},
{
"type": "SECONDARY",
"title": "Overall Survival (OS)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "79",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "13.5",
"comment": "The upper limit is not calculable.",
"groupId": "OG000",
"lowerLimit": "10.7",
"upperLimit": "NA"
},
{
"value": "NA",
"comment": "The NAs are not calculable due to insufficient number of participants with events.",
"groupId": "OG001",
"lowerLimit": "NA",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "Overall survival is defined as the time from the date of the first dose of study intervention to the date of death due to any cause.",
"unitOfMeasure": "Month",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "FAS: Enrolled participants who have received at least one dose of treatment.\nParticipants who were enrolled but did not subsequently receive study intervention are not included in the analysis."
},
{
"type": "SECONDARY",
"title": "Progression-Free Survival (PFS) , Assessed by Investigator",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "79",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "4.3",
"groupId": "OG000",
"lowerLimit": "4.0",
"upperLimit": "5.6"
},
{
"value": "7.0",
"groupId": "OG001",
"lowerLimit": "5.5",
"upperLimit": "8.5"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "Progression-free survival is defined as time from the date of the first dose of study intervention until progression per RECIST 1.1, as assessed by investigator, or death due to any cause.",
"unitOfMeasure": "Month",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "FAS: Enrolled participants who have received at least one dose of treatment.\nParticipants who were enrolled but did not subsequently receive study intervention are not included in the analysis."
},
{
"type": "SECONDARY",
"title": "Disease Control Rate (DCR), Assessed by Investigator",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "77",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "76.6",
"groupId": "OG000",
"lowerLimit": "65.6",
"upperLimit": "85.5"
},
{
"value": "85.0",
"groupId": "OG001",
"lowerLimit": "70.2",
"upperLimit": "94.3"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "Duration of response is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression per RECIST 1.1, as assessed by investigator, or death due to any cause.",
"unitOfMeasure": "Percentage",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR."
},
{
"type": "SECONDARY",
"title": "Best Overall Response (BoR) , Assessed by Investigator",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "77",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"title": "Confirmed complete response",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Confirmed partial response",
"categories": [
{
"measurements": [
{
"value": "31.2",
"groupId": "OG000"
},
{
"value": "37.5",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "Best overall response is defined as participant's best confirmed response during their participation in the study, but prior to starting any subsequent anticancer therapy, up until RECIST 1.1-defined PD or the last evaluable assessment in the absence of RECIST 1.1-defined progression.",
"unitOfMeasure": "Percentage",
"reportingStatus": "POSTED",
"populationDescription": "RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR."
},
{
"type": "SECONDARY",
"title": "Time To Response (TTR) , Assessed by Investigator",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "25",
"groupId": "OG000"
},
{
"value": "13",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "1.4",
"groupId": "OG000",
"lowerLimit": "1.4",
"upperLimit": "1.6"
},
{
"value": "1.4",
"groupId": "OG001",
"lowerLimit": "1.3",
"upperLimit": "1.4"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "Time to response is defined as the time from the date of the first dose of study intervention until the date of first documented objective response, which is subsequently confirmed per RECIST 1.1.",
"unitOfMeasure": "Month",
"dispersionType": "Inter-Quartile Range",
"reportingStatus": "POSTED",
"populationDescription": "<p>FAS: Enrolled participants who have received at least one dose of treatment.\nParticipants who were enrolled but did not subsequently receive study intervention are not included in the analysis.</p><p>The analysis for TTR assessed by investigator was based on the responders in the FAS of each cohort.</p>"
},
{
"type": "SECONDARY",
"title": "Pharmacokinetic Parameter: Area Under the Plasma Concentration- Time Curve (AUC) _ Total Anti-TROP2 Antibody",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "9",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "713.9",
"spread": "25.45",
"groupId": "OG000"
},
{
"value": "569.3",
"spread": "24.47",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "GEOMETRIC_MEAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "PK parameters of Total Anti-TROP2 Antibody_Area under the curve",
"unitOfMeasure": "day*ug/mL",
"dispersionType": "Geometric Coefficient of Variation",
"reportingStatus": "POSTED",
"populationDescription": "<p>PK analysis set:Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd.</p><p>The analysis for AUC was based on the patients with intensive PK collection of each cohort.</p>"
},
{
"type": "SECONDARY",
"title": "Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) _ Total Anti-TROP2 Antibody",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "79",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "137.8",
"spread": "19.09",
"groupId": "OG000"
},
{
"value": "121.1",
"spread": "22.38",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "GEOMETRIC_MEAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "PK parameters of Total Anti-TROP2 Antibody_Maximum observed concentration",
"unitOfMeasure": "ug/mL",
"dispersionType": "Geometric Coefficient of Variation",
"reportingStatus": "POSTED",
"populationDescription": "PK analysis set:Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd."
},
{
"type": "SECONDARY",
"title": "Pharmacokinetic Parameter: Area Under the Plasma Concentration- Time Curve (AUC) _Dato-DXd",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "9",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "668.3",
"spread": "21.11",
"groupId": "OG000"
},
{
"value": "504.5",
"spread": "22.38",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "GEOMETRIC_MEAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "PK parameters of Dato-DXd_Area under the curve",
"unitOfMeasure": "day*ug/mL",
"dispersionType": "Geometric Coefficient of Variation",
"reportingStatus": "POSTED",
"populationDescription": "<p>PK analysis set:Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd.</p><p>The analysis for AUC was based on the patients with intensive PK collection of each cohort.</p>"
},
{
"type": "SECONDARY",
"title": "Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) _ Dato-DXd",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "79",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "136.4",
"spread": "20.18",
"groupId": "OG000"
},
{
"value": "115.4",
"spread": "18.12",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "GEOMETRIC_MEAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "PK parameters of Dato-DXd_Maximum observed concentration",
"unitOfMeasure": "ug/mL",
"dispersionType": "Geometric Coefficient of Variation",
"reportingStatus": "POSTED",
"populationDescription": "PK analysis set:Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd."
},
{
"type": "SECONDARY",
"title": "Pharmacokinetic Parameter: Area Under the Plasma Concentration- Time Curve (AUC) _ MAAA-1181a",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "9",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "17.60",
"spread": "24.64",
"groupId": "OG000"
},
{
"value": "17.66",
"spread": "33.09",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "GEOMETRIC_MEAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "PK parameters of MAAA-1181a_Area under the curve",
"unitOfMeasure": "day*ng/mL",
"dispersionType": "Geometric Coefficient of Variation",
"reportingStatus": "POSTED",
"populationDescription": "<p>PK analysis set:Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd.</p><p>The analysis for AUC was based on the patients with intensive PK collection of each cohort.</p>"
},
{
"type": "SECONDARY",
"title": "Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) _ MAAA-1181a",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "79",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "2.484",
"spread": "45.09",
"groupId": "OG000"
},
{
"value": "2.463",
"spread": "42.31",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "GEOMETRIC_MEAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "PK parameters of MAAA-1181a_Maximum observed concentration",
"unitOfMeasure": "ng/mL",
"dispersionType": "Geometric Coefficient of Variation",
"reportingStatus": "POSTED",
"populationDescription": "PK analysis set:Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd."
},
{
"type": "SECONDARY",
"title": "Pharmacokinetic Parameter: Time to Maximum Plasma Concentration (Tmax) _Total Anti-TROP2 Antibody",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "79",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "2.00",
"groupId": "OG000",
"lowerLimit": "1.40",
"upperLimit": "7.17"
},
{
"value": "1.70",
"groupId": "OG001",
"lowerLimit": "0.90",
"upperLimit": "6.83"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "PK parameters of Total Anti-TROP2 Antibody_Time to maximum plasma concentration",
"unitOfMeasure": "Hour",
"dispersionType": "Full Range",
"reportingStatus": "POSTED",
"populationDescription": "PK analysis set: Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd."
},
{
"type": "SECONDARY",
"title": "Pharmacokinetic Parameter: Time to Maximum Plasma Concentration (Tmax) _Dato-DXd",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "79",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "1.92",
"groupId": "OG000",
"lowerLimit": "1.12",
"upperLimit": "7.17"
},
{
"value": "1.77",
"groupId": "OG001",
"lowerLimit": "0.90",
"upperLimit": "5.22"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "Time to maximum plasma concentration",
"unitOfMeasure": "h",
"dispersionType": "Full Range",
"reportingStatus": "POSTED",
"populationDescription": "PK analysis set: Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd."
},
{
"type": "SECONDARY",
"title": "Pharmacokinetic Parameter: Time to Maximum Plasma Concentration (Tmax) _ MAAA-1181a",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "79",
"groupId": "OG000"
},
{
"value": "40",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "5.00",
"groupId": "OG000",
"lowerLimit": "1.67",
"upperLimit": "24.22"
},
{
"value": "4.98",
"groupId": "OG001",
"lowerLimit": "4.77",
"upperLimit": "25.07"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "PK parameters of MAAA-1181a_Time to maximum plasma concentration",
"unitOfMeasure": "Hour",
"dispersionType": "Full Range",
"reportingStatus": "POSTED",
"populationDescription": "PK analysis set: Enrolled participants who have received at least one dose of treatment and had measurable serum concentrations of Dato-DXd."
},
{
"type": "SECONDARY",
"title": "Immunogenicity of Dato-DXd",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "75",
"groupId": "OG000"
},
{
"value": "38",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "33.3",
"groupId": "OG000"
},
{
"value": "36.8",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "The prevalence of ADA (positive at any visit)",
"unitOfMeasure": "percentage",
"reportingStatus": "POSTED",
"populationDescription": "ADA Evaluable Set: Participants in the FAS with a non-missing baseline Dato-DXd ADA result and at least one post-baseline Dato-DXd ADA result."
},
{
"type": "SECONDARY",
"title": "Duration of Response (DoR), Assessed by ICR",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "26",
"groupId": "OG000"
},
{
"value": "18",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "OG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "6.7",
"groupId": "OG000",
"lowerLimit": "4.53",
"upperLimit": "12.6"
},
{
"value": "8.3",
"comment": "The upper limit is not calculable due to insufficient number of participants with events",
"groupId": "OG001",
"lowerLimit": "5.9",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "TNBC cohort: from enrollment to 12 months post last subject dose with an average of 12 months follow up. NSCLC cohort: from enrollment to 6 months post last subject dose with an average of 8 months follow up.",
"description": "Duration of response is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression per RECIST 1.1, as assessed by ICR, or death due to any cause.",
"unitOfMeasure": "Month",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "<p>RES: Enrolled participants who received at least one dose of study intervention and had measurable disease at baseline by ICR.</p><p>The analysis for DOR assessed by ICR was based on the responders in the RES of each cohort.</p>"
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "FG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
}
],
"periods": [
{
"title": "Overall Study",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "79"
},
{
"groupId": "FG001",
"numSubjects": "40"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "29"
},
{
"comment": "NSCLC cohort has not reached final analysis.",
"groupId": "FG001",
"numSubjects": "0"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "50"
},
{
"groupId": "FG001",
"numSubjects": "40"
}
]
}
],
"dropWithdraws": [
{
"type": "Death",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "43"
},
{
"groupId": "FG001",
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}
]
},
{
"type": "Lost to Follow-up",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "7"
},
{
"groupId": "FG001",
"numSubjects": "0"
}
]
},
{
"type": "Ongoing participants at NSCLC primary analysis DCO",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "31"
}
]
}
]
}
],
"recruitmentDetails": "<p>This Phase 1/2, open-label, multiple-cohort, single-arm study was conducted in participants with Advanced Non-Small-Cell Lung Cancer (NSCLC) and Triple-Negative Breast Cancer(TNBC) in China.</p><ul><li>For TNBC cohort, first participant was screened on 11Jul2022, last participant was screened on 27Apr2023.</li><li>For NSCLC cohort, first participant was screened on 29Aug2022, last participant was screened on 21Mar2023.</li></ul>",
"preAssignmentDetails": "<p>Overall 168 participants were screened at 23 centers in China.\nA total of 119 participants were treated with Dato-DXd.</p><ul><li>For TNBC cohort, 106 participant was screened at 14 centers in China.\n79 participants received Dato-DXd at the 14 centers.</li><li>For NSCLC cohort, 62 participant was screened at 12 centers in China.\n40 participants received Dato-DXd at 11 centers.</li></ul><p>Note: 3 centers screened both TNBC participants and NSCLC participants.</p>"
},
"baselineCharacteristicsModule": {
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "79",
"groupId": "BG000"
},
{
"value": "40",
"groupId": "BG001"
},
{
"value": "119",
"groupId": "BG002"
}
]
}
],
"groups": [
{
"id": "BG000",
"title": "TNBC Cohort",
"description": "Final Analysis with DCO on 06May2024"
},
{
"id": "BG001",
"title": "NSCLC Cohort",
"description": "Primary Analysis with DCO on 09Oct2023"
},
{
"id": "BG002",
"title": "Total",
"description": "Total of all reporting groups"
}
],
"measures": [
{
"title": "Age, Customized",
"classes": [
{
"title": "<50",
"categories": [
{
"measurements": [
{
"value": "39",
"groupId": "BG000"
},
{
"value": "6",
"groupId": "BG001"
},
{
"value": "45",
"groupId": "BG002"
}
]
}
]
},
{
"title": "50-65",
"categories": [
{
"measurements": [
{
"value": "31",
"groupId": "BG000"
},
{
"value": "20",
"groupId": "BG001"
},
{
"value": "51",
"groupId": "BG002"
}
]
}
]
},
{
"title": "65-75",
"categories": [
{
"measurements": [
{
"value": "9",
"groupId": "BG000"
},
{
"value": "14",
"groupId": "BG001"
},
{
"value": "23",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "NUMBER",
"unitOfMeasure": "Participants"
},
{
"title": "Sex: Female, Male",
"classes": [
{
"categories": [
{
"title": "Female",
"measurements": [
{
"value": "79",
"groupId": "BG000"
},
{
"value": "11",
"groupId": "BG001"
},
{
"value": "90",
"groupId": "BG002"
}
]
},
{
"title": "Male",
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "29",
"groupId": "BG001"
},
{
"value": "29",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Race/Ethnicity, Customized",
"classes": [
{
"title": "ASIAN",
"categories": [
{
"measurements": [
{
"value": "79",
"groupId": "BG000"
},
{
"value": "40",
"groupId": "BG001"
},
{
"value": "119",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "NUMBER",
"unitOfMeasure": "Participants"
},
{
"title": "Region of Enrollment",
"classes": [
{
"title": "China",
"categories": [
{
"measurements": [
{
"value": "79",
"groupId": "BG000"
},
{
"value": "40",
"groupId": "BG001"
},
{
"value": "119",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "NUMBER",
"unitOfMeasure": "Participants"
}
],
"populationDescription": "FAS: Enrolled participants who have received at least one dose of treatment."
}
}
},
{
"op": "add",
"path": "/documentSection",
"value": {
"largeDocumentModule": {
"largeDocs": [
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"date": "2023-05-29",
"size": 7732633,
"label": "Study Protocol",
"hasIcf": false,
"hasSap": false,
"filename": "Prot_000.pdf",
"typeAbbrev": "Prot",
"uploadDate": "2024-10-31T06:24",
"hasProtocol": true
},
{
"date": "2023-08-30",
"size": 1210633,
"label": "Statistical Analysis Plan",
"hasIcf": false,
"hasSap": true,
"filename": "SAP_001.pdf",
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}
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}
}
}
]