Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2025-05-23"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2025-06-11"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2025-05-23"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2025-06-11",
"type": "ACTUAL"
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/description",
"value": "<p>Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening and every 2 cycles during study treatment.</p><p>Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nPartial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.\nStable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.\nComplete Response (CR): Disappearance of all target lesions.\nAny pathological lymph nodes (whether target or non- target) must have reduction in short axis to < 10 mm.</p>"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame",
"value": "Imaging for Disease status (tumour measurements) occurred after every even cycle for the full duration of treatment and at EOT visit up to approximately 24 weeks total"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes",
"value": [
{
"measure": "PK Profile of Total Antibody",
"timeFrame": "Cycle 1 Profile (ie the first 3 weeks of dosing)",
"description": "Characterization of the pharmacokinetic profile of total antibody"
}
]
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description",
"value": "<p>Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening and every 2 cycles during study treatment.</p><p>Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nPartial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.\nStable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.\nComplete Response (CR): Disappearance of all target lesions.\nAny pathological lymph nodes (whether target or non- target) must have reduction in short axis to < 10 mm.</p>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame",
"value": "Imaging for Disease status (tumour measurements) occurred after every even cycle for the full duration of treatment and at EOT visit up to approximately 24 weeks total"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/reviewUnit"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2",
"value": {
"type": "SECONDARY",
"title": "PK Profile of Total Antibody",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1",
"groupId": "OG000"
},
{
"value": "1",
"groupId": "OG001"
},
{
"value": "3",
"groupId": "OG002"
},
{
"value": "3",
"groupId": "OG003"
},
{
"value": "3",
"groupId": "OG004"
},
{
"value": "6",
"groupId": "OG005"
},
{
"value": "7",
"groupId": "OG006"
},
{
"value": "9",
"groupId": "OG007"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "AVID100 20 mg/m^2",
"description": "Phase 1 Cohort 1: Participants were administered 20 mg/m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
},
{
"id": "OG001",
"title": "AVID100 40 mg/m^2",
"description": "Phase 1 Cohort 1: Participants were administered 40 mg/m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
},
{
"id": "OG002",
"title": "AVID100 80 mg/m^2",
"description": "Phase 1 Cohort 1: Participants were administered 80 mg/m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
},
{
"id": "OG003",
"title": "AVID100 120 mg/m^2",
"description": "Phase 1 Cohort 1: Participants were administered 120 mg/m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
},
{
"id": "OG004",
"title": "AVID100 180 mg/m^2",
"description": "Phase 1 Cohort 1: Participants were administered 180 mg/m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
},
{
"id": "OG005",
"title": "AVID100 220 mg/m^2",
"description": "Phase 1 Cohort 1: Participants were administered 220 mg/m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
},
{
"id": "OG006",
"title": "AVID100 270 mg/m^2",
"description": "Phase 1 Cohort 1: Participants were administered 270 mg/m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
},
{
"id": "OG007",
"title": "Phase 2a Expansion: AVID100 220 mg/m^2",
"description": "Participants from expanded populations of mTNBC, SCCHN, and Sq-NSCLC with documented EGFR expression received the maximum tolerated dose (MTD) determined in Phase 1, comprising AVID100 220 mg/m^2 administered every 3 weeks IV, for at least 1 cycle.\nExtended treatment was permitted for participants tolerating and benefiting from treatment."
}
],
"classes": [
{
"title": "Cycle 1 D1 prior SOI",
"categories": [
{
"measurements": [
{
"value": "NA",
"comment": "BLQ (below detection limit)",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "BLQ (below detection limit)",
"groupId": "OG001"
},
{
"value": "NA",
"spread": "NA",
"comment": "BLQ (below detection limit)",
"groupId": "OG002"
},
{
"value": "NA",
"spread": "NA",
"comment": "BLQ (below detection limit)",
"groupId": "OG003"
},
{
"value": "NA",
"spread": "NA",
"comment": "BLQ (below detection limit)",
"groupId": "OG004"
},
{
"value": "NA",
"spread": "NA",
"comment": "BLQ (below detection limit)",
"groupId": "OG005"
},
{
"value": "NA",
"spread": "NA",
"comment": "BLQ (below detection limit)",
"groupId": "OG006"
},
{
"value": "NA",
"spread": "NA",
"comment": "BLQ (below detection limit)",
"groupId": "OG007"
}
]
}
]
},
{
"title": "Cycle D1 EOI",
"categories": [
{
"measurements": [
{
"value": "9213.3",
"groupId": "OG000"
},
{
"value": "13686.7",
"groupId": "OG001"
},
{
"value": "41140.7",
"spread": "7472.0",
"groupId": "OG002"
},
{
"value": "71440.9",
"spread": "9107.3",
"groupId": "OG003"
},
{
"value": "85982.9",
"spread": "8517.2",
"groupId": "OG004"
},
{
"value": "113401.6",
"spread": "18740.3",
"groupId": "OG005"
},
{
"value": "136306.3",
"spread": "16938.5",
"groupId": "OG006"
},
{
"value": "122464.3",
"spread": "20790.1",
"groupId": "OG007"
}
]
}
]
},
{
"title": "Cycle 1 D1 2h post SOI",
"categories": [
{
"measurements": [
{
"value": "8066.3",
"groupId": "OG000"
},
{
"value": "14003.5",
"groupId": "OG001"
},
{
"value": "36935.8",
"spread": "7089.3",
"groupId": "OG002"
},
{
"value": "66587.4",
"spread": "6199.4",
"groupId": "OG003"
},
{
"value": "89676.6",
"spread": "6216.5",
"groupId": "OG004"
},
{
"value": "112663.3",
"spread": "21616.7",
"groupId": "OG005"
},
{
"value": "131267.2",
"spread": "10585.7",
"groupId": "OG006"
},
{
"value": "NA",
"spread": "NA",
"comment": "Timepoint not assessed in Phase 2a expansion",
"groupId": "OG007"
}
]
}
]
},
{
"title": "Cycle 1 D1 4h post SOI",
"categories": [
{
"measurements": [
{
"value": "8351.9",
"groupId": "OG000"
},
{
"value": "14555.1",
"groupId": "OG001"
},
{
"value": "34399.7",
"spread": "5940.6",
"groupId": "OG002"
},
{
"value": "61468.6",
"spread": "4879.1",
"groupId": "OG003"
},
{
"value": "79581.1",
"spread": "9542.3",
"groupId": "OG004"
},
{
"value": "101809.1",
"spread": "17330.1",
"groupId": "OG005"
},
{
"value": "132671.4",
"spread": "13243.3",
"groupId": "OG006"
},
{
"value": "NA",
"spread": "NA",
"comment": "Timepoint not assessed in Phase 2a expansion",
"groupId": "OG007"
}
]
}
]
},
{
"title": "Cycle 1 D2",
"categories": [
{
"measurements": [
{
"value": "3217.6",
"groupId": "OG000"
},
{
"value": "9390.7",
"groupId": "OG001"
},
{
"value": "25236.4",
"spread": "2159.3",
"groupId": "OG002"
},
{
"value": "43504.6",
"spread": "5940.3",
"groupId": "OG003"
},
{
"value": "63001.5",
"spread": "5837.3",
"groupId": "OG004"
},
{
"value": "68284.5",
"spread": "6605.4",
"groupId": "OG005"
},
{
"value": "99382.8",
"spread": "13832.9",
"groupId": "OG006"
},
{
"value": "NA",
"spread": "NA",
"comment": "Timepoint not assessed in Phase 2a expansion",
"groupId": "OG007"
}
]
}
]
},
{
"title": "Cycle 1 D4",
"categories": [
{
"measurements": [
{
"value": "876.3",
"groupId": "OG000"
},
{
"value": "4578.3",
"groupId": "OG001"
},
{
"value": "14638.5",
"spread": "1776.9",
"groupId": "OG002"
},
{
"value": "24985.3",
"spread": "6859.7",
"groupId": "OG003"
},
{
"value": "35500.0",
"spread": "5004.5",
"groupId": "OG004"
},
{
"value": "38068.0",
"spread": "7890.3",
"groupId": "OG005"
},
{
"value": "69578.4",
"spread": "10616.0",
"groupId": "OG006"
},
{
"value": "NA",
"spread": "NA",
"comment": "Timepoint not assessed in Phase 2a expansion",
"groupId": "OG007"
}
]
}
]
},
{
"title": "Cycle 1 D8",
"categories": [
{
"measurements": [
{
"value": "NA",
"comment": "BLQ (below detection limit)",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "BLQ (below detection limit)",
"groupId": "OG001"
},
{
"value": "2450.7",
"spread": "1422.7",
"groupId": "OG002"
},
{
"value": "8768.0",
"spread": "5393.1",
"groupId": "OG003"
},
{
"value": "12590.0",
"spread": "1531.9",
"groupId": "OG004"
},
{
"value": "18581.5",
"spread": "3128.7",
"groupId": "OG005"
},
{
"value": "27982.5",
"spread": "13531.7",
"groupId": "OG006"
},
{
"value": "NA",
"spread": "NA",
"comment": "Timepoint not assessed in Phase 2a expansion",
"groupId": "OG007"
}
]
}
]
},
{
"title": "Cycle 2 D1 prior to SOI",
"categories": [
{
"measurements": [
{
"value": "NA",
"comment": "BLQ (below detection limit)",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "BLQ (below detection limit)",
"groupId": "OG001"
},
{
"value": "NA",
"spread": "NA",
"comment": "BLQ (below detection limit)",
"groupId": "OG002"
},
{
"value": "NA",
"spread": "NA",
"comment": "BLQ (below detection limit)",
"groupId": "OG003"
},
{
"value": "NA",
"spread": "NA",
"comment": "BLQ (below detection limit)",
"groupId": "OG004"
},
{
"value": "NA",
"spread": "NA",
"comment": "BLQ (below detection limit)",
"groupId": "OG005"
},
{
"value": "866.5",
"spread": "855.8",
"groupId": "OG006"
},
{
"value": "131.1",
"spread": "40.6",
"groupId": "OG007"
}
]
}
]
}
],
"paramType": "MEAN",
"timeFrame": "Cycle 1 Profile (ie the first 3 weeks of dosing)",
"description": "Characterization of the pharmacokinetic profile of total antibody",
"unitOfMeasure": "ng/mL",
"dispersionType": "Standard Deviation",
"reportingStatus": "POSTED",
"populationDescription": "Patients who have completed Cycle 1 for which PK analysis was performed"
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/timeFrame",
"value": "Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total."
},
{
"op": "remove",
"path": "/resultsSection/adverseEventsModule/reviewUnit"
},
{
"op": "remove",
"path": "/annotationSection"
},
{
"op": "remove",
"path": "/reviewUnit"
}
]