NCT04278144
Version 33 to 34 · Bolt Biotherapeutics, Inc.
Patch inspector
Manual review pending.
None recorded.
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] bb03b0a152856b1d0fdaa020fb958ee542815246715f79f537d7383ab4831c01/protocolSection/outcomesModule/primaryOutcomes/0/measure primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Incidence of adverse events (AEs) and serious adverse events (SAEs)
Incidence of Treatment Emergent Adverse Events (TEAEs)
/protocolSection/outcomesModule/primaryOutcomes/0/description primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Escalation period
Number of participants with at least 1 TEAE graded according to NCI CTCAE v5.0
/protocolSection/outcomesModule/primaryOutcomes/1/measure primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Incidence and nature of dose-limiting toxicities (DLTs)
Incidence of Participants With Serious TEAEs
/protocolSection/outcomesModule/primaryOutcomes/1/description primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Escalation period
Number of participants with at least 1 Serious TEAE graded according to NCI CTCAE v5.0.
/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. up to 21 days
2 years
/protocolSection/outcomesModule/primaryOutcomes/2/measure primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Incidence of potential-immune related toxicities
Incidence Dose-limiting Toxicities (DLTs)
/protocolSection/outcomesModule/primaryOutcomes/2/description primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Escalation period
DLTs occurring in the first 21 days after study drug administration
/protocolSection/outcomesModule/primaryOutcomes/2/timeFrame primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. 2 years
Up to 21 days
/protocolSection/outcomesModule/primaryOutcomes/3 primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. {
"measure": "Maximum tolerable dose (MTD) or a tolerated dose below MTD",
"timeFrame": "2 years",
"description": "Escalation period"
} /protocolSection/outcomesModule/primaryOutcomes/3 primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. {
"measure": "Objective response rate (ORR) of confirmed complete or partial responses (CR, PR)",
"timeFrame": "2 years",
"description": "Expansion period"
} /protocolSection/outcomesModule/secondaryOutcomes/0/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. PK (Cmax) of BDC-1001
Objective Response Rate (ORR)
/protocolSection/outcomesModule/secondaryOutcomes/0/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Escalation and expansion periods
Objective Response Rate (ORR) was defined as the proportion of participants with best overall response of confirmed Complete Response (CR) or Partial Response (PR) as determined by the treating Investigator using RECIST v1.1 criteria.
/protocolSection/outcomesModule/secondaryOutcomes/1/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. PK (Cmin) of BDC-1001
Duration of Response (DOR)
/protocolSection/outcomesModule/secondaryOutcomes/1/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Escalation and expansion periods
Duration of Response (DOR) was calculated for participants who achieved confirmed CR or PR. For such participants, DOR is defined as the duration from the start date of CR or PR (whichever response status is observed first) and subsequently confirmed, to the earliest of documented date of PD per RECIST v 1.1 or death.
/protocolSection/outcomesModule/secondaryOutcomes/2/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. PK (AUC0-t) of BDC-1001
Progression Free Survival (PFS)
/protocolSection/outcomesModule/secondaryOutcomes/2/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Escalation period
Progression-free survival (PFS) was defined as the duration from the date of first study treatment administration (Cycle 1 Day 1) to the earliest date of documented PD per RECIST v1.1 or death. A death was considered a PFS event.
/protocolSection/outcomesModule/secondaryOutcomes/3/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. PK (AUC0-inf) of BDC-1001
Treatment Induced Incidence of Anti-BDC-1001 Antibodies (ADA)
/protocolSection/outcomesModule/secondaryOutcomes/3/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Escalation period
Formation of ADA has been monitored with a bridging enzyme linked immune-absorbent assay (ELISA) assay. The confirmatory assay had a sensitivity of 127 ng/mL, drug tolerance of up to 60-fold more drug than ADAs, soluble HER2 tolerance of 250 ng/mL and tolerance of interference from nivolumab of 100 ug/mL. Detection of treatment-induced ADAs was not associated with alteration of BDC-1001 exposure, increased AEs, nor disease progression.
/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. 2 years
Pre-infusion at Cycle 1 and 3, and then pre-infusion every 2 - 4 weeks, until treatment termination.
/protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
} /protocolSection/outcomesModule/secondaryOutcomes/4/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. PK (CL) of BDC-1001
Minimum Serum Concentration (Cmin) of BDC-1001
/protocolSection/outcomesModule/secondaryOutcomes/4/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Escalation period
Cmin at steady state for BDC-1001 was calculated from serum concentrations using Population PK analysis.
/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. 2 years
Pre-infusion and at end of infusion for Cycles 1-4, at 1 hour and 4 hours post-infusion during Cycles 1-3 with additional samples at specified visits, and then pre-infusion and at end of infusion every 4 - 6 weeks, until treatment termination.
/protocolSection/outcomesModule/secondaryOutcomes/4/reviewUnit secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"resetReasons": [
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]
} /protocolSection/outcomesModule/secondaryOutcomes/5/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. PK (Vz) of BDC-1001
Maximum Serum Concentration (Cmax) of BDC-1001
/protocolSection/outcomesModule/secondaryOutcomes/5/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Escalation period
Cmax at steady state for BDC-1001 was calculated from serum concentrations using Population PK analysis.
/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. 2 years
Pre-infusion and at end of infusion for Cycles 1-4, at 1 hour and 4 hours post-infusion during Cycles 1-3 with additional samples at specified visits, and then pre-infusion and at end of infusion every 4 - 6 weeks, until treatment termination.
/protocolSection/outcomesModule/secondaryOutcomes/5/reviewUnit secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"resetReasons": [
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]
} /protocolSection/outcomesModule/secondaryOutcomes/6/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. PK (t1/2) of BDC-1001
Area Under the Curve (AUC) of BDC-1001
/protocolSection/outcomesModule/secondaryOutcomes/6/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Escalation period
Area under the concentration-time curve (AUC), calculated over the dosing interval following repeated dosing
/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. 2 years
Pre-infusion and at end of infusion for Cycles 1-4, at 1 hour and 4 hours post-infusion during Cycles 1-3 with additional samples at specified visits, and then pre-infusion and at end of infusion every 4 - 6 weeks, until treatment termination.
/protocolSection/outcomesModule/secondaryOutcomes/6/reviewUnit secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"resetReasons": [
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]
} /protocolSection/outcomesModule/secondaryOutcomes/7 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Objective response rate (ORR) using RECIST 1.1",
"timeFrame": "2 years",
"description": "Escalation period"
} /protocolSection/outcomesModule/secondaryOutcomes/7 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Duration of response (DOR)",
"timeFrame": "2 years",
"description": "Escalation and expansion periods"
} /protocolSection/outcomesModule/secondaryOutcomes/7 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Disease control rate (DCR) of confirmed CR, PR, or stable disease (SD) lasting 4 or more weeks",
"timeFrame": "2 years",
"description": "Escalation and expansion periods"
} /protocolSection/outcomesModule/secondaryOutcomes/7 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Progression Free Survival (PFS)",
"timeFrame": "2 years",
"description": "Escalation and expansion periods"
} /protocolSection/outcomesModule/secondaryOutcomes/7 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Incidence of anti-BDC-1001 antibodies",
"timeFrame": "2 years",
"description": "Escalation and expansion periods"
} /protocolSection/outcomesModule/secondaryOutcomes/7 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Incidence of adverse events (AEs) and serious adverse events (SAEs)",
"timeFrame": "2 years",
"description": "Expansion period"
} /protocolSection/outcomesModule/secondaryOutcomes/7 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Incidence of potential-immune related toxicities",
"timeFrame": "2 years",
"description": "Expansion period"
} /protocolSection/contactsLocationsModule/locations/19/state Madrid
/protocolSection/contactsLocationsModule/locations/20/state Madrid
/protocolSection/statusModule/expandedAccessInfo {
"hasExpandedAccess": false
} /protocolSection/statusModule/lastUpdateSubmitDate 2025-09-09
2025-12-10
/protocolSection/statusModule/lastUpdatePostDateStruct/date 2025-09-15
2025-12-30
/protocolSection/statusModule/resultsFirstSubmitDate 2025-12-10
/protocolSection/statusModule/resultsFirstSubmitQcDate 2025-12-10
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"type": "ACTUAL"
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true
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"pointOfContact": {
"email": "clinicaltrials@boltbio.com",
"phone": "1-650-434-8640",
"title": "Director of Clinical Development Operations",
"organization": "Bolt Biotherapeutics, Inc."
},
"certainAgreement": {
"piSponsorEmployee": false,
"restrictiveAgreement": true
}
},
"adverseEventsModule": {
"timeFrame": "From the first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 2 years.",
"description": "The safety population included the participants who received at least one dose of study treatment.",
"eventGroups": [
{
"id": "EG000",
"title": "Single Agent BDC-1001",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p>",
"otherNumAtRisk": 138,
"deathsNumAtRisk": 138,
"otherNumAffected": 125,
"seriousNumAtRisk": 138,
"deathsNumAffected": 86,
"seriousNumAffected": 48
},
{
"id": "EG001",
"title": "Combination BDC-1001 Plus Nivolumab",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p><p>Nivolumab: Programmed death receptor-1 (PD 1)-blocking antibody</p>",
"otherNumAtRisk": 37,
"deathsNumAtRisk": 37,
"otherNumAffected": 34,
"seriousNumAtRisk": 37,
"deathsNumAffected": 19,
"seriousNumAffected": 11
}
],
"otherEvents": [
{
"term": "Anaemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 57,
"numAffected": 32
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 11,
"numAffected": 4
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Abdominal pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 27,
"numAffected": 26
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 15,
"numAffected": 6
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Ascites",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 8,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Constipation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 19,
"numAffected": 18
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 6,
"numAffected": 6
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Diarrhoea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 21,
"numAffected": 18
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 11,
"numAffected": 8
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Nausea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 34,
"numAffected": 33
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 10,
"numAffected": 10
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Vomiting",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 20,
"numAffected": 18
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 17,
"numAffected": 12
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Asthenia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 8,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Chills",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 12,
"numAffected": 10
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Fatigue",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 44,
"numAffected": 37
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 8,
"numAffected": 7
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Oedema peripheral",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 10,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 6,
"numAffected": 4
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Pyrexia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 17,
"numAffected": 15
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Urinary tract infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 9,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 5,
"numAffected": 4
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Infusion related reaction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 74,
"numAffected": 39
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 15,
"numAffected": 10
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Alanine aminotransferase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 13,
"numAffected": 11
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 5,
"numAffected": 2
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Aspartate aminotransferase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 25,
"numAffected": 20
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 4,
"numAffected": 2
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Blood bilirubin increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 8,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Ejection fraction decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 9,
"numAffected": 9
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Weight decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 9,
"numAffected": 9
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Decreased appetite",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 24,
"numAffected": 21
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 7,
"numAffected": 6
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Hypoalbuminaemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 13,
"numAffected": 11
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Hypokalaemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 17,
"numAffected": 9
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 3,
"numAffected": 2
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Hyponatraemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 12,
"numAffected": 9
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Arthralgia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 15,
"numAffected": 14
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Back pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 8,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 5,
"numAffected": 5
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
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"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Pneumothorax",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Pulmonary embolism",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Pulmonary haemorrhage",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
}
],
"armsReviewUnit": {
"resetReasons": [
"The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
]
},
"frequencyThreshold": "5"
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "Incidence of Treatment Emergent Adverse Events (TEAEs)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "138",
"groupId": "OG000"
},
{
"value": "37",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Single Agent BDC-1001",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p>"
},
{
"id": "OG001",
"title": "Combination BDC-1001 Plus Nivolumab",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p><p>Nivolumab: Programmed death receptor-1 (PD 1)-blocking antibody</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "133",
"groupId": "OG000"
},
{
"value": "36",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "2 years",
"description": "Number of participants with at least 1 TEAE graded according to NCI CTCAE v5.0",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "Treatment-emergent AEs (TEAEs) are defined as AEs that start on or after the first administration of study drug.",
"measureCategoriesReviewUnit": {
"resetReasons": [
"The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
]
}
},
{
"type": "PRIMARY",
"title": "Incidence of Participants With Serious TEAEs",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "138",
"groupId": "OG000"
},
{
"value": "37",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Single Agent BDC-1001",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p>"
},
{
"id": "OG001",
"title": "Combination BDC-1001 Plus Nivolumab - Dose Escalation",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p><p>Nivolumab: Programmed death receptor-1 (PD 1)-blocking antibody</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "48",
"groupId": "OG000"
},
{
"value": "11",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "2 years",
"description": "Number of participants with at least 1 Serious TEAE graded according to NCI CTCAE v5.0.",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"measureCategoriesReviewUnit": {
"resetReasons": [
"The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
]
}
},
{
"type": "PRIMARY",
"title": "Incidence Dose-limiting Toxicities (DLTs)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "93",
"groupId": "OG000"
},
{
"value": "34",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Single Agent BDC-1001",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p>"
},
{
"id": "OG001",
"title": "Combination BDC-1001 Plus Nivolumab",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p><p>Nivolumab: Programmed death receptor-1 (PD 1)-blocking antibody</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "1",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "Up to 21 days",
"description": "DLTs occurring in the first 21 days after study drug administration",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "DLT by Preferred Term in DLT Evaluable Population",
"measureCategoriesReviewUnit": {
"resetReasons": [
"The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
]
}
},
{
"type": "SECONDARY",
"title": "Objective Response Rate (ORR)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "122",
"groupId": "OG000"
},
{
"value": "32",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Single Agent BDC-1001",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p>"
},
{
"id": "OG001",
"title": "Combination BDC-1001 Plus Nivolumab",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p><p>Nivolumab: Programmed death receptor-1 (PD 1)-blocking antibody</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "4",
"groupId": "OG000"
},
{
"value": "3",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "2 years",
"description": "Objective Response Rate (ORR) was defined as the proportion of participants with best overall response of confirmed Complete Response (CR) or Partial Response (PR) as determined by the treating Investigator using RECIST v1.1 criteria.",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "Rates were based on participants who were tumor evaluable (had at least one baseline and one post-baseline tumor response data).",
"measureCategoriesReviewUnit": {
"resetReasons": [
"The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
]
}
},
{
"type": "SECONDARY",
"title": "Duration of Response (DOR)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "138",
"groupId": "OG000"
},
{
"value": "37",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Single Agent BDC-1001",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p>"
},
{
"id": "OG001",
"title": "Combination BDC-1001 Plus Nivolumab",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p><p>Nivolumab: Programmed death receptor-1 (PD 1)-blocking antibody</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "13.17",
"comment": "It was not possible to calculate the upper 95% confidence interval due to the insufficient number of participants with events.",
"groupId": "OG000",
"lowerLimit": "5.82",
"upperLimit": "NA"
},
{
"value": "5.68",
"comment": "It was not possible to calculate the upper 95% confidence interval due to the insufficient number of participants with events.",
"groupId": "OG001",
"lowerLimit": "2.76",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "2 years",
"description": "Duration of Response (DOR) was calculated for participants who achieved confirmed CR or PR.\nFor such participants, DOR is defined as the duration from the start date of CR or PR (whichever response status is observed first) and subsequently confirmed, to the earliest of documented date of PD per RECIST v 1.1 or death.",
"unitOfMeasure": "Months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "DOR was calculated based on the total number of participants who had CR or PR in each cohort.",
"measureCategoriesReviewUnit": {
"resetReasons": [
"The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided.",
"The number of participants analyzed appears inconsistent with data here or in other parts of the record."
]
}
},
{
"type": "SECONDARY",
"title": "Progression Free Survival (PFS)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "138",
"groupId": "OG000"
},
{
"value": "37",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Single Agent BDC-1001",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p>"
},
{
"id": "OG001",
"title": "Combination BDC-1001 Plus Nivolumab",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p><p>Nivolumab: Programmed death receptor-1 (PD 1)-blocking antibody</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "1.38",
"groupId": "OG000",
"lowerLimit": "1.25",
"upperLimit": "1.41"
},
{
"value": "1.40",
"groupId": "OG001",
"lowerLimit": "1.22",
"upperLimit": "4.11"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "2 years",
"description": "Progression-free survival (PFS) was defined as the duration from the date of first study treatment administration (Cycle 1 Day 1) to the earliest date of documented PD per RECIST v1.1 or death.\nA death was considered a PFS event.",
"unitOfMeasure": "Months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Rates were based on participants who have at least one baseline and one post-baseline Tumor Response data.",
"measureCategoriesReviewUnit": {
"resetReasons": [
"The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
]
}
},
{
"type": "SECONDARY",
"title": "Treatment Induced Incidence of Anti-BDC-1001 Antibodies (ADA)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "129",
"groupId": "OG000"
},
{
"value": "37",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Single Agent BDC-1001",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p>"
},
{
"id": "OG001",
"title": "Combination BDC-1001 Plus Nivolumab",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p><p>Nivolumab: Programmed death receptor-1 (PD 1)-blocking antibody</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "11",
"groupId": "OG000"
},
{
"value": "7",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "Pre-infusion at Cycle 1 and 3, and then pre-infusion every 2 - 4 weeks, until treatment termination.",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "Formation of ADA has been monitored with a bridging enzyme linked immune-absorbent assay (ELISA) assay.\nThe confirmatory assay had a sensitivity of 127 ng/mL, drug tolerance of up to 60-fold more drug than ADAs, soluble HER2 tolerance of 250 ng/mL and tolerance of interference from nivolumab of 100 ug/mL.\nDetection of treatment-induced ADAs was not associated with alteration of BDC-1001 exposure, increased AEs, nor disease progression.",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "Evaluable participants with any baseline or post baseline ADA assessment.",
"measureCategoriesReviewUnit": {
"resetReasons": [
"The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
]
}
},
{
"type": "SECONDARY",
"title": "Minimum Serum Concentration (Cmin) of BDC-1001",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "15",
"groupId": "OG000"
},
{
"value": "11",
"groupId": "OG001"
},
{
"value": "8",
"groupId": "OG002"
},
{
"value": "10",
"groupId": "OG003"
},
{
"value": "5",
"groupId": "OG004"
},
{
"value": "8",
"groupId": "OG005"
},
{
"value": "7",
"groupId": "OG006"
},
{
"value": "4",
"groupId": "OG007"
},
{
"value": "9",
"groupId": "OG008"
},
{
"value": "4",
"groupId": "OG009"
},
{
"value": "7",
"groupId": "OG010"
},
{
"value": "7",
"groupId": "OG011"
},
{
"value": "9",
"groupId": "OG012"
},
{
"value": "3",
"groupId": "OG013"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "BDC-1001 5 mg/kg q3w",
"description": "Participants received 5 mg/kg of BDC-1001 intravenously (IV) once every 3 weeks (q3w) on Day 1 of 21-day cycles"
},
{
"id": "OG001",
"title": "BDC-1001 8 mg/kg q3w",
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 3 weeks (q3w)"
},
{
"id": "OG002",
"title": "BDC-1001 12 mg/kg q3w",
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 3 weeks (q3w)"
},
{
"id": "OG003",
"title": "BDC-1001 20 mg/kg q3w",
"description": "Participants received 20 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 3 weeks (q3w)"
},
{
"id": "OG004",
"title": "BDC-1001 8 mg/kg q2w",
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 2 weeks (q2w)"
},
{
"id": "OG005",
"title": "BDC-1001 12 mg/kg q2w",
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 2 weeks (q2w)"
},
{
"id": "OG006",
"title": "BDC-1001 20 mg/kg q2w",
"description": "Participants received 20 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 2 weeks (q2w)"
},
{
"id": "OG007",
"title": "BDC-1001 8 mg/kg q1w",
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) on Day 1 every week (q1w)"
},
{
"id": "OG008",
"title": "BDC-1001 12 mg/kg q1w",
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) on Day 1 every week (q1w)"
},
{
"id": "OG009",
"title": "BDC-1001 20 mg/kg q1w",
"description": "Participants received 20 mg/kg of BDC-1001 intravenously (IV) on Day 1 every week (q1w)"
},
{
"id": "OG010",
"title": "BDC-1001 12 mg/kg + Nivolumab q2w",
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) and 360 mg nivolumab on Day 1 every 2 weeks (q2w)"
},
{
"id": "OG011",
"title": "BDC-1001 20 mg/kg + Nivolumab q2w",
"description": "Participants received 20 mg/kg of BDC-1001 intravenously (IV) and 360 mg nivolumab on Day 1 every 2 weeks (q2w)"
},
{
"id": "OG012",
"title": "BDC-1001 8 mg/kg + Nivolumab q1w",
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) and 240 mg nivolumab on Day 1 every 1 week (q1w)"
},
{
"id": "OG013",
"title": "BDC-1001 12 mg/kg + Nivolumab q1w",
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) and 240 mg nivolumab on Day 1 every 1 week (q1w)"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "0.13",
"groupId": "OG000",
"lowerLimit": "0.0016",
"upperLimit": "3.1"
},
{
"value": "0.78",
"groupId": "OG001",
"lowerLimit": "0.01",
"upperLimit": "2.4"
},
{
"value": "1.0",
"groupId": "OG002",
"lowerLimit": "0.069",
"upperLimit": "4.5"
},
{
"value": "2.9",
"groupId": "OG003",
"lowerLimit": "0.82",
"upperLimit": "5.6"
},
{
"value": "2.7",
"groupId": "OG004",
"lowerLimit": "1.04",
"upperLimit": "20"
},
{
"value": "5.5",
"groupId": "OG005",
"lowerLimit": "1.6",
"upperLimit": "11"
},
{
"value": "14",
"groupId": "OG006",
"lowerLimit": "0.35",
"upperLimit": "19"
},
{
"value": "16",
"groupId": "OG007",
"lowerLimit": "13",
"upperLimit": "41"
},
{
"value": "44",
"groupId": "OG008",
"lowerLimit": "13",
"upperLimit": "120"
},
{
"value": "36",
"groupId": "OG009",
"lowerLimit": "20",
"upperLimit": "66"
},
{
"value": "3.1",
"groupId": "OG010",
"lowerLimit": "1.5",
"upperLimit": "17"
},
{
"value": "10",
"groupId": "OG011",
"lowerLimit": "0.091",
"upperLimit": "79"
},
{
"value": "18",
"groupId": "OG012",
"lowerLimit": "9.8",
"upperLimit": "48"
},
{
"value": "12",
"groupId": "OG013",
"lowerLimit": "11",
"upperLimit": "40"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "Pre-infusion and at end of infusion for Cycles 1-4, at 1 hour and 4 hours post-infusion during Cycles 1-3 with additional samples at specified visits, and then pre-infusion and at end of infusion every 4 - 6 weeks, until treatment termination.",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "Cmin at steady state for BDC-1001 was calculated from serum concentrations using Population PK analysis.",
"unitOfMeasure": "µg/mL",
"dispersionType": "Full Range",
"reportingStatus": "POSTED",
"populationDescription": "Participants who received at least one dose of BDC-1001 and had at least one evaluable post-dose PK concentration."
},
{
"type": "SECONDARY",
"title": "Maximum Serum Concentration (Cmax) of BDC-1001",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "15",
"groupId": "OG000"
},
{
"value": "11",
"groupId": "OG001"
},
{
"value": "8",
"groupId": "OG002"
},
{
"value": "10",
"groupId": "OG003"
},
{
"value": "5",
"groupId": "OG004"
},
{
"value": "8",
"groupId": "OG005"
},
{
"value": "7",
"groupId": "OG006"
},
{
"value": "4",
"groupId": "OG007"
},
{
"value": "9",
"groupId": "OG008"
},
{
"value": "4",
"groupId": "OG009"
},
{
"value": "7",
"groupId": "OG010"
},
{
"value": "7",
"groupId": "OG011"
},
{
"value": "9",
"groupId": "OG012"
},
{
"value": "3",
"groupId": "OG013"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "BDC-1001 5 mg/kg q3w",
"description": "Participants received 5 mg/kg of BDC-1001 intravenously (IV) once every 3 weeks (q3w) on Day 1 of 21-day cycles"
},
{
"id": "OG001",
"title": "BDC-1001 8 mg/kg q3w",
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 3 weeks (q3w)"
},
{
"id": "OG002",
"title": "BDC-1001 12 mg/kg q3w",
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 3 weeks (q3w)"
},
{
"id": "OG003",
"title": "BDC-1001 20 mg/kg q3w",
"description": "Participants received 20 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 3 weeks (q3w)"
},
{
"id": "OG004",
"title": "BDC-1001 8 mg/kg q2w",
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 2 weeks (q2w)"
},
{
"id": "OG005",
"title": "BDC-1001 12 mg/kg q2w",
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 2 weeks (q2w)"
},
{
"id": "OG006",
"title": "BDC-1001 20 mg/kg q2w",
"description": "Participants received 20 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 2 weeks (q2w)"
},
{
"id": "OG007",
"title": "BDC-1001 8 mg/kg q1w",
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"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"value": "Duration of Response (DOR) was calculated for participants who achieved confirmed CR or PR.\nFor such participants, DOR is defined as the duration from the start date of CR or PR (whichever response status is observed first) and subsequently confirmed, to the earliest of documented date of PD per RECIST v 1.1 or death."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"value": "Progression Free Survival (PFS)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"value": "Progression-free survival (PFS) was defined as the duration from the date of first study treatment administration (Cycle 1 Day 1) to the earliest date of documented PD per RECIST v1.1 or death.\nA death was considered a PFS event."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"value": "Treatment Induced Incidence of Anti-BDC-1001 Antibodies (ADA)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
"value": "Formation of ADA has been monitored with a bridging enzyme linked immune-absorbent assay (ELISA) assay.\nThe confirmatory assay had a sensitivity of 127 ng/mL, drug tolerance of up to 60-fold more drug than ADAs, soluble HER2 tolerance of 250 ng/mL and tolerance of interference from nivolumab of 100 ug/mL.\nDetection of treatment-induced ADAs was not associated with alteration of BDC-1001 exposure, increased AEs, nor disease progression."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"value": "Pre-infusion at Cycle 1 and 3, and then pre-infusion every 2 - 4 weeks, until treatment termination."
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
"value": "Minimum Serum Concentration (Cmin) of BDC-1001"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
"value": "Cmin at steady state for BDC-1001 was calculated from serum concentrations using Population PK analysis."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
"value": "Pre-infusion and at end of infusion for Cycles 1-4, at 1 hour and 4 hours post-infusion during Cycles 1-3 with additional samples at specified visits, and then pre-infusion and at end of infusion every 4 - 6 weeks, until treatment termination."
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
"value": "Maximum Serum Concentration (Cmax) of BDC-1001"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
"value": "Cmax at steady state for BDC-1001 was calculated from serum concentrations using Population PK analysis."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
"value": "Pre-infusion and at end of infusion for Cycles 1-4, at 1 hour and 4 hours post-infusion during Cycles 1-3 with additional samples at specified visits, and then pre-infusion and at end of infusion every 4 - 6 weeks, until treatment termination."
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
"value": "Area Under the Curve (AUC) of BDC-1001"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/description",
"value": "Area under the concentration-time curve (AUC), calculated over the dosing interval following repeated dosing"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame",
"value": "Pre-infusion and at end of infusion for Cycles 1-4, at 1 hour and 4 hours post-infusion during Cycles 1-3 with additional samples at specified visits, and then pre-infusion and at end of infusion every 4 - 6 weeks, until treatment termination."
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/7"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/7"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/7"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/7"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/7"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/7"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/7"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/19/state"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/20/state"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"moreInfoModule": {
"pointOfContact": {
"email": "clinicaltrials@boltbio.com",
"phone": "1-650-434-8640",
"title": "Director of Clinical Development Operations",
"organization": "Bolt Biotherapeutics, Inc."
},
"certainAgreement": {
"piSponsorEmployee": false,
"restrictiveAgreement": true
}
},
"adverseEventsModule": {
"timeFrame": "From the first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 2 years.",
"description": "The safety population included the participants who received at least one dose of study treatment.",
"eventGroups": [
{
"id": "EG000",
"title": "Single Agent BDC-1001",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p>",
"otherNumAtRisk": 138,
"deathsNumAtRisk": 138,
"otherNumAffected": 125,
"seriousNumAtRisk": 138,
"deathsNumAffected": 86,
"seriousNumAffected": 48
},
{
"id": "EG001",
"title": "Combination BDC-1001 Plus Nivolumab",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p><p>Nivolumab: Programmed death receptor-1 (PD 1)-blocking antibody</p>",
"otherNumAtRisk": 37,
"deathsNumAtRisk": 37,
"otherNumAffected": 34,
"seriousNumAtRisk": 37,
"deathsNumAffected": 19,
"seriousNumAffected": 11
}
],
"otherEvents": [
{
"term": "Anaemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 57,
"numAffected": 32
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 11,
"numAffected": 4
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Abdominal pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 27,
"numAffected": 26
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 15,
"numAffected": 6
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Ascites",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 8,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Constipation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 19,
"numAffected": 18
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 6,
"numAffected": 6
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Diarrhoea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 21,
"numAffected": 18
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 11,
"numAffected": 8
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Nausea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 34,
"numAffected": 33
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 10,
"numAffected": 10
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Vomiting",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 20,
"numAffected": 18
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 17,
"numAffected": 12
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Asthenia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 8,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Chills",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 12,
"numAffected": 10
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Fatigue",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 44,
"numAffected": 37
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 8,
"numAffected": 7
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Oedema peripheral",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 10,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 6,
"numAffected": 4
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Pyrexia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 17,
"numAffected": 15
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Urinary tract infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 9,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 5,
"numAffected": 4
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Infusion related reaction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 74,
"numAffected": 39
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 15,
"numAffected": 10
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Alanine aminotransferase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 13,
"numAffected": 11
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 5,
"numAffected": 2
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Aspartate aminotransferase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 25,
"numAffected": 20
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 4,
"numAffected": 2
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Blood bilirubin increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 8,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Ejection fraction decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 9,
"numAffected": 9
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Weight decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 9,
"numAffected": 9
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Decreased appetite",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 24,
"numAffected": 21
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 7,
"numAffected": 6
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Hypoalbuminaemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 13,
"numAffected": 11
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Hypokalaemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 17,
"numAffected": 9
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 3,
"numAffected": 2
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Hyponatraemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 12,
"numAffected": 9
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Arthralgia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 15,
"numAffected": 14
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Back pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 8,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 5,
"numAffected": 5
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Dizziness",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 7,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 8,
"numAffected": 6
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Headache",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 14,
"numAffected": 12
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Cough",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 14,
"numAffected": 11
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 3,
"numAffected": 2
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Dyspnoea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 19,
"numAffected": 17
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
}
],
"seriousEvents": [
{
"term": "Anaemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 3,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Blood loss anaemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Supraventricular tachycardia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Ear discomfort",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Adrenal insufficiency",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Endocrine disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Abdominal pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 4,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Dysphagia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Gastric haemorrhage",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Gastrointestinal haemorrhage",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.0"
},
{
"term": "Large intestinal obstruction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 138,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 37,
"numEvents": 0,
"numAffected": 0
}
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"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "Up to 21 days",
"description": "DLTs occurring in the first 21 days after study drug administration",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "DLT by Preferred Term in DLT Evaluable Population",
"measureCategoriesReviewUnit": {
"resetReasons": [
"The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
]
}
},
{
"type": "SECONDARY",
"title": "Objective Response Rate (ORR)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "122",
"groupId": "OG000"
},
{
"value": "32",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Single Agent BDC-1001",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p>"
},
{
"id": "OG001",
"title": "Combination BDC-1001 Plus Nivolumab",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p><p>Nivolumab: Programmed death receptor-1 (PD 1)-blocking antibody</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "4",
"groupId": "OG000"
},
{
"value": "3",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "2 years",
"description": "Objective Response Rate (ORR) was defined as the proportion of participants with best overall response of confirmed Complete Response (CR) or Partial Response (PR) as determined by the treating Investigator using RECIST v1.1 criteria.",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "Rates were based on participants who were tumor evaluable (had at least one baseline and one post-baseline tumor response data).",
"measureCategoriesReviewUnit": {
"resetReasons": [
"The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
]
}
},
{
"type": "SECONDARY",
"title": "Duration of Response (DOR)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "138",
"groupId": "OG000"
},
{
"value": "37",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Single Agent BDC-1001",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p>"
},
{
"id": "OG001",
"title": "Combination BDC-1001 Plus Nivolumab",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p><p>Nivolumab: Programmed death receptor-1 (PD 1)-blocking antibody</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "13.17",
"comment": "It was not possible to calculate the upper 95% confidence interval due to the insufficient number of participants with events.",
"groupId": "OG000",
"lowerLimit": "5.82",
"upperLimit": "NA"
},
{
"value": "5.68",
"comment": "It was not possible to calculate the upper 95% confidence interval due to the insufficient number of participants with events.",
"groupId": "OG001",
"lowerLimit": "2.76",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "2 years",
"description": "Duration of Response (DOR) was calculated for participants who achieved confirmed CR or PR.\nFor such participants, DOR is defined as the duration from the start date of CR or PR (whichever response status is observed first) and subsequently confirmed, to the earliest of documented date of PD per RECIST v 1.1 or death.",
"unitOfMeasure": "Months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "DOR was calculated based on the total number of participants who had CR or PR in each cohort.",
"measureCategoriesReviewUnit": {
"resetReasons": [
"The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided.",
"The number of participants analyzed appears inconsistent with data here or in other parts of the record."
]
}
},
{
"type": "SECONDARY",
"title": "Progression Free Survival (PFS)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "138",
"groupId": "OG000"
},
{
"value": "37",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Single Agent BDC-1001",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p>"
},
{
"id": "OG001",
"title": "Combination BDC-1001 Plus Nivolumab",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p><p>Nivolumab: Programmed death receptor-1 (PD 1)-blocking antibody</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "1.38",
"groupId": "OG000",
"lowerLimit": "1.25",
"upperLimit": "1.41"
},
{
"value": "1.40",
"groupId": "OG001",
"lowerLimit": "1.22",
"upperLimit": "4.11"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "2 years",
"description": "Progression-free survival (PFS) was defined as the duration from the date of first study treatment administration (Cycle 1 Day 1) to the earliest date of documented PD per RECIST v1.1 or death.\nA death was considered a PFS event.",
"unitOfMeasure": "Months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Rates were based on participants who have at least one baseline and one post-baseline Tumor Response data.",
"measureCategoriesReviewUnit": {
"resetReasons": [
"The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
]
}
},
{
"type": "SECONDARY",
"title": "Treatment Induced Incidence of Anti-BDC-1001 Antibodies (ADA)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "129",
"groupId": "OG000"
},
{
"value": "37",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Single Agent BDC-1001",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p>"
},
{
"id": "OG001",
"title": "Combination BDC-1001 Plus Nivolumab",
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p><p>Nivolumab: Programmed death receptor-1 (PD 1)-blocking antibody</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "11",
"groupId": "OG000"
},
{
"value": "7",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "Pre-infusion at Cycle 1 and 3, and then pre-infusion every 2 - 4 weeks, until treatment termination.",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "Formation of ADA has been monitored with a bridging enzyme linked immune-absorbent assay (ELISA) assay.\nThe confirmatory assay had a sensitivity of 127 ng/mL, drug tolerance of up to 60-fold more drug than ADAs, soluble HER2 tolerance of 250 ng/mL and tolerance of interference from nivolumab of 100 ug/mL.\nDetection of treatment-induced ADAs was not associated with alteration of BDC-1001 exposure, increased AEs, nor disease progression.",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "Evaluable participants with any baseline or post baseline ADA assessment.",
"measureCategoriesReviewUnit": {
"resetReasons": [
"The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
]
}
},
{
"type": "SECONDARY",
"title": "Minimum Serum Concentration (Cmin) of BDC-1001",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "15",
"groupId": "OG000"
},
{
"value": "11",
"groupId": "OG001"
},
{
"value": "8",
"groupId": "OG002"
},
{
"value": "10",
"groupId": "OG003"
},
{
"value": "5",
"groupId": "OG004"
},
{
"value": "8",
"groupId": "OG005"
},
{
"value": "7",
"groupId": "OG006"
},
{
"value": "4",
"groupId": "OG007"
},
{
"value": "9",
"groupId": "OG008"
},
{
"value": "4",
"groupId": "OG009"
},
{
"value": "7",
"groupId": "OG010"
},
{
"value": "7",
"groupId": "OG011"
},
{
"value": "9",
"groupId": "OG012"
},
{
"value": "3",
"groupId": "OG013"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "BDC-1001 5 mg/kg q3w",
"description": "Participants received 5 mg/kg of BDC-1001 intravenously (IV) once every 3 weeks (q3w) on Day 1 of 21-day cycles"
},
{
"id": "OG001",
"title": "BDC-1001 8 mg/kg q3w",
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 3 weeks (q3w)"
},
{
"id": "OG002",
"title": "BDC-1001 12 mg/kg q3w",
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 3 weeks (q3w)"
},
{
"id": "OG003",
"title": "BDC-1001 20 mg/kg q3w",
"description": "Participants received 20 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 3 weeks (q3w)"
},
{
"id": "OG004",
"title": "BDC-1001 8 mg/kg q2w",
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 2 weeks (q2w)"
},
{
"id": "OG005",
"title": "BDC-1001 12 mg/kg q2w",
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 2 weeks (q2w)"
},
{
"id": "OG006",
"title": "BDC-1001 20 mg/kg q2w",
"description": "Participants received 20 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 2 weeks (q2w)"
},
{
"id": "OG007",
"title": "BDC-1001 8 mg/kg q1w",
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) on Day 1 every week (q1w)"
},
{
"id": "OG008",
"title": "BDC-1001 12 mg/kg q1w",
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) on Day 1 every week (q1w)"
},
{
"id": "OG009",
"title": "BDC-1001 20 mg/kg q1w",
"description": "Participants received 20 mg/kg of BDC-1001 intravenously (IV) on Day 1 every week (q1w)"
},
{
"id": "OG010",
"title": "BDC-1001 12 mg/kg + Nivolumab q2w",
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) and 360 mg nivolumab on Day 1 every 2 weeks (q2w)"
},
{
"id": "OG011",
"title": "BDC-1001 20 mg/kg + Nivolumab q2w",
"description": "Participants received 20 mg/kg of BDC-1001 intravenously (IV) and 360 mg nivolumab on Day 1 every 2 weeks (q2w)"
},
{
"id": "OG012",
"title": "BDC-1001 8 mg/kg + Nivolumab q1w",
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) and 240 mg nivolumab on Day 1 every 1 week (q1w)"
},
{
"id": "OG013",
"title": "BDC-1001 12 mg/kg + Nivolumab q1w",
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) and 240 mg nivolumab on Day 1 every 1 week (q1w)"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "0.13",
"groupId": "OG000",
"lowerLimit": "0.0016",
"upperLimit": "3.1"
},
{
"value": "0.78",
"groupId": "OG001",
"lowerLimit": "0.01",
"upperLimit": "2.4"
},
{
"value": "1.0",
"groupId": "OG002",
"lowerLimit": "0.069",
"upperLimit": "4.5"
},
{
"value": "2.9",
"groupId": "OG003",
"lowerLimit": "0.82",
"upperLimit": "5.6"
},
{
"value": "2.7",
"groupId": "OG004",
"lowerLimit": "1.04",
"upperLimit": "20"
},
{
"value": "5.5",
"groupId": "OG005",
"lowerLimit": "1.6",
"upperLimit": "11"
},
{
"value": "14",
"groupId": "OG006",
"lowerLimit": "0.35",
"upperLimit": "19"
},
{
"value": "16",
"groupId": "OG007",
"lowerLimit": "13",
"upperLimit": "41"
},
{
"value": "44",
"groupId": "OG008",
"lowerLimit": "13",
"upperLimit": "120"
},
{
"value": "36",
"groupId": "OG009",
"lowerLimit": "20",
"upperLimit": "66"
},
{
"value": "3.1",
"groupId": "OG010",
"lowerLimit": "1.5",
"upperLimit": "17"
},
{
"value": "10",
"groupId": "OG011",
"lowerLimit": "0.091",
"upperLimit": "79"
},
{
"value": "18",
"groupId": "OG012",
"lowerLimit": "9.8",
"upperLimit": "48"
},
{
"value": "12",
"groupId": "OG013",
"lowerLimit": "11",
"upperLimit": "40"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "Pre-infusion and at end of infusion for Cycles 1-4, at 1 hour and 4 hours post-infusion during Cycles 1-3 with additional samples at specified visits, and then pre-infusion and at end of infusion every 4 - 6 weeks, until treatment termination.",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "Cmin at steady state for BDC-1001 was calculated from serum concentrations using Population PK analysis.",
"unitOfMeasure": "µg/mL",
"dispersionType": "Full Range",
"reportingStatus": "POSTED",
"populationDescription": "Participants who received at least one dose of BDC-1001 and had at least one evaluable post-dose PK concentration."
},
{
"type": "SECONDARY",
"title": "Maximum Serum Concentration (Cmax) of BDC-1001",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "15",
"groupId": "OG000"
},
{
"value": "11",
"groupId": "OG001"
},
{
"value": "8",
"groupId": "OG002"
},
{
"value": "10",
"groupId": "OG003"
},
{
"value": "5",
"groupId": "OG004"
},
{
"value": "8",
"groupId": "OG005"
},
{
"value": "7",
"groupId": "OG006"
},
{
"value": "4",
"groupId": "OG007"
},
{
"value": "9",
"groupId": "OG008"
},
{
"value": "4",
"groupId": "OG009"
},
{
"value": "7",
"groupId": "OG010"
},
{
"value": "7",
"groupId": "OG011"
},
{
"value": "9",
"groupId": "OG012"
},
{
"value": "3",
"groupId": "OG013"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "BDC-1001 5 mg/kg q3w",
"description": "Participants received 5 mg/kg of BDC-1001 intravenously (IV) once every 3 weeks (q3w) on Day 1 of 21-day cycles"
},
{
"id": "OG001",
"title": "BDC-1001 8 mg/kg q3w",
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 3 weeks (q3w)"
},
{
"id": "OG002",
"title": "BDC-1001 12 mg/kg q3w",
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 3 weeks (q3w)"
},
{
"id": "OG003",
"title": "BDC-1001 20 mg/kg q3w",
"description": "Participants received 20 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 3 weeks (q3w)"
},
{
"id": "OG004",
"title": "BDC-1001 8 mg/kg q2w",
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 2 weeks (q2w)"
},
{
"id": "OG005",
"title": "BDC-1001 12 mg/kg q2w",
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 2 weeks (q2w)"
},
{
"id": "OG006",
"title": "BDC-1001 20 mg/kg q2w",
"description": "Participants received 20 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 2 weeks (q2w)"
},
{
"id": "OG007",
"title": "BDC-1001 8 mg/kg q1w",
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) on Day 1 every week (q1w)"
},
{
"id": "OG008",
"title": "BDC-1001 12 mg/kg q1w",
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) on Day 1 every week (q1w)"
},
{
"id": "OG009",
"title": "BDC-1001 20 mg/kg q1w",
"description": "Participants received 20 mg/kg of BDC-1001 intravenously (IV) on Day 1 every week (q1w)"
},
{
"id": "OG010",
"title": "BDC-1001 12 mg/kg + Nivolumab q2w",
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) and 360 mg nivolumab on Day 1 every 2 weeks (q2w)"
},
{
"id": "OG011",
"title": "BDC-1001 20 mg/kg + Nivolumab q2w",
"description": "Participants received 20 mg/kg of BDC-1001 intravenously (IV) and 360 mg nivolumab on Day 1 every 2 weeks (q2w)"
},
{
"id": "OG012",
"title": "BDC-1001 8 mg/kg + Nivolumab q1w",
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) and 240 mg nivolumab on Day 1 every 1 week (q1w)"
},
{
"id": "OG013",
"title": "BDC-1001 12 mg/kg + Nivolumab q1w",
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) and 240 mg nivolumab on Day 1 every 1 week (q1w)"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "96",
"groupId": "OG000",
"lowerLimit": "75",
"upperLimit": "120"
},
{
"value": "110",
"groupId": "OG001",
"lowerLimit": "80",
"upperLimit": "150"
},
{
"value": "150",
"groupId": "OG002",
"lowerLimit": "93",
"upperLimit": "200"
},
{
"value": "290",
"groupId": "OG003",
"lowerLimit": "220",
"upperLimit": "380"
},
{
"value": "150",
"groupId": "OG004",
"lowerLimit": "88",
"upperLimit": "180"
},
{
"value": "200",
"groupId": "OG005",
"lowerLimit": "160",
"upperLimit": "250"
},
{
"value": "300",
"groupId": "OG006",
"lowerLimit": "270",
"upperLimit": "350"
},
{
"value": "140",
"groupId": "OG007",
"lowerLimit": "110",
"upperLimit": "180"
},
{
"value": "220",
"groupId": "OG008",
"lowerLimit": "120",
"upperLimit": "400"
},
{
"value": "360",
"groupId": "OG009",
"lowerLimit": "280",
"upperLimit": "510"
},
{
"value": "210",
"groupId": "OG010",
"lowerLimit": "160",
"upperLimit": "280"
},
{
"value": "340",
"groupId": "OG011",
"lowerLimit": "270",
"upperLimit": "480"
},
{
"value": "160",
"groupId": "OG012",
"lowerLimit": "140",
"upperLimit": "200"
},
{
"value": "170",
"groupId": "OG013",
"lowerLimit": "160",
"upperLimit": "270"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "Pre-infusion and at end of infusion for Cycles 1-4, at 1 hour and 4 hours post-infusion during Cycles 1-3 with additional samples at specified visits, and then pre-infusion and at end of infusion every 4 - 6 weeks, until treatment termination.",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "Cmax at steady state for BDC-1001 was calculated from serum concentrations using Population PK analysis.",
"unitOfMeasure": "µg/mL",
"dispersionType": "Full Range",
"reportingStatus": "POSTED",
"populationDescription": "Participants who received at least one dose of BDC-1001 and had at least one evaluable post-dose PK concentration."
},
{
"type": "SECONDARY",
"title": "Area Under the Curve (AUC) of BDC-1001",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "15",
"groupId": "OG000"
},
{
"value": "11",
"groupId": "OG001"
},
{
"value": "8",
"groupId": "OG002"
},
{
"value": "10",
"groupId": "OG003"
},
{
"value": "5",
"groupId": "OG004"
},
{
"value": "8",
"groupId": "OG005"
},
{
"value": "7",
"groupId": "OG006"
},
{
"value": "4",
"groupId": "OG007"
},
{
"value": "9",
"groupId": "OG008"
},
{
"value": "4",
"groupId": "OG009"
},
{
"value": "7",
"groupId": "OG010"
},
{
"value": "7",
"groupId": "OG011"
},
{
"value": "9",
"groupId": "OG012"
},
{
"value": "3",
"groupId": "OG013"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "BDC-1001 5 mg/kg q3w",
"description": "Participants received 5 mg/kg of BDC-1001 intravenously (IV) once every 3 weeks (q3w) on Day 1 of 21-day cycles"
},
{
"id": "OG001",
"title": "BDC-1001 8 mg/kg q3w",
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 3 weeks (q3w)"
},
{
"id": "OG002",
"title": "BDC-1001 12 mg/kg q3w",
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 3 weeks (q3w)"
},
{
"id": "OG003",
"title": "BDC-1001 20 mg/kg q3w",
"description": "Participants received 20 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 3 weeks (q3w)"
},
{
"id": "OG004",
"title": "BDC-1001 8 mg/kg q2w",
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 2 weeks (q2w)"
},
{
"id": "OG005",
"title": "BDC-1001 12 mg/kg q2w",
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 2 weeks (q2w)"
},
{
"id": "OG006",
"title": "BDC-1001 20 mg/kg q2w",
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},
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},
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