Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-03-11 @ 1:30 PM
Study NCT ID:
NCT03094169
Status:
TERMINATED
Last Update Posted:
2025-06-11
First Post:
2017-02-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
AVID100 in Advanced Epithelial Carcinomas
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sandra@forbius.com', 'phone': '8326221699', 'title': 'Sandra Sinclair', 'organization': 'Formation Biologics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '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.', 'eventGroups': [{'id': 'EG000', '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.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', '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.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', '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.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', '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.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', '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.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', '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.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG006', '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.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG007', '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. Extended treatment was permitted for participants tolerating and benefiting from treatment.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 25, 'seriousNumAtRisk': 25, 'deathsNumAffected': 3, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Conjunctivitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Blood Bilirubin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Tumour Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Lymphocyte Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Blood Alkaline Phosphate Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Lipase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Aspartate Aminotransferase Increased', 'notes': 'MedDRA 23.0 used for Phase 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 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'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Creatine Kinase increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Multifocal pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Shortness of Breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Elevated AST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase 1 Dose Escalation: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) in Cycle 1', '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'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation Phase 1-Cohort 1', 'description': '1 Patient treated at 20mg/m2, AVID100 IV is administered once every 3 weeks'}, {'id': 'OG001', 'title': 'Dose Escalation Phase 1-Cohort 2', 'description': '1 Patient treated at 40mg/m2, AVID100 IV is administered IV once every 3 weeks'}, {'id': 'OG002', 'title': 'Dose Escalation Phase 1-Cohort 3', 'description': '3 Patients treated at 80mg/m2, AVID100 IV administered once every 3 weeks'}, {'id': 'OG003', 'title': 'Dose Escalation Phase 1-Cohort 4', 'description': '3 Patients treated at 120mg/m2, AVID100 IV is administered once every 3 weeks'}, {'id': 'OG004', 'title': 'Dose Escalation Phase 1-Cohort 5', 'description': '3 Patients treated at 180mg/m2, AVID100 IV is administered once every 3 weeks'}, {'id': 'OG005', 'title': 'Dose Escalation Phase 1-Cohort 6', 'description': '6 Patients treated at 220 mg/m2, AVID100 IV is administered once every 3 weeks'}, {'id': 'OG006', 'title': 'Dose Escalation Phase 1-Cohort 7', 'description': '7 Patients treated at 270mg/m2, AVID100 IV is administered once every 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 1 during Dose Escalation (ie the first 3 weeks of dosing)', 'description': 'Any of the following toxicities, if judged to be associated with study, were considered a DLT:\n\n1. Evidence of pulmonary fibrosis\n2. G3 non-hematologic toxicity regardless of duration with the exceptions of:\n\n * G3 nausea, vomiting, diarrhea, or fatigue lasting \\< 2 days\n * G3 asymptomatic electrolyte abnormalities lasting \\< 3 days not considered clinically relevant\n3. AST and/or ALT elevation \\> 3 x ULN with total bilirubin \\> 2 x ULN without initial findings of cholestasis, that cannot be explained by other factors\n4. Any G4 non-hematologic toxicity with the exception of:\n\n • G4 asymptomatic electrolyte abnormalities lasting \\< 7 days not considered clinically significant\n5. Neutropenia that is:\n\n * \\> G3 and associated with fever\n * G4 and sustained (ANC \\< 500 per mm3, duration \\> 5 days)\n6. Thrombocytopenia that is:\n\n * G3 with clinically significant hemorrhage or requirement for transfusion\n * G4 (platelets \\< 25,000 per mm3)\n7. Inability to complete Cycle 1 at the assigned dose', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Phase 2a: Number of Participants With Best Overall Response by RECIST 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', '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. Extended treatment was permitted for participants tolerating and benefiting from treatment.'}], 'classes': [{'categories': [{'title': 'Progressive Disease', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Stable Disease', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Complete Response', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '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', 'description': 'Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening and every 2 cycles during study treatment.\n\nProgressive 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). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable 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. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non- target) must have reduction in short axis to \\< 10 mm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who completed Cycle 2 (6 weeks) of treatment, received at least 2 planned doses during that period, and had a follow-up assessment of disease status were considered evaluable for assessment of antineoplastic activity. Patients who were withdrawn from the study before completion of Cycle 2 because of progressive disease also were included in assessments of antineoplastic activity.'}, {'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. Extended 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'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', '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': 'FG001', 'title': 'AVID100 40 mg/m^2', 'description': 'Phase 1 Cohort 2: 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': 'FG002', 'title': 'AVID100 80 mg/m^2', 'description': 'Phase 1 Cohort 3: 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': 'FG003', 'title': 'AVID100 120 mg/m^2', 'description': 'Phase 1 Cohort 4: 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': 'FG004', 'title': 'AVID100 180 mg/m^2', 'description': 'Phase 1 Cohort 5: 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': 'FG005', 'title': 'AVID100 220 mg/m^2', 'description': 'Phase 1 Cohort 6: 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': 'FG006', 'title': 'AVID100 270 mg/m^2', 'description': 'Phase 1 Cohort 7: 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': 'FG007', '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. Extended treatment was permitted for participants tolerating and benefiting from treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '21'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Trial Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '25', 'groupId': 'BG007'}, {'value': '49', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', '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': 'BG001', 'title': 'AVID100 40 mg/m^2', 'description': 'Phase 1 Cohort 2: 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': 'BG002', 'title': 'AVID100 80 mg/m^2 Cohort 3', 'description': 'Phase 1 Cohort 3: 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': 'BG003', 'title': 'AVID100 120 mg/m^2', 'description': 'Phase 1 Cohort 4: 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': 'BG004', 'title': 'AVID100 180 mg/m^2', 'description': 'Phase 1 Cohort 5: 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': 'BG005', 'title': 'AVID100 220 mg/m^2', 'description': 'Phase 1 Cohort 6: 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': 'BG006', 'title': 'AVID100 270 mg/m^2', 'description': 'Phase 1 Cohort 7: 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': 'BG007', '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. Extended treatment was permitted for participants tolerating and benefiting from treatment.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}, {'value': '32', 'groupId': 'BG008'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '17', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '24', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '15', 'groupId': 'BG007'}, {'value': '25', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '22', 'groupId': 'BG007'}, {'value': '43', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}, {'value': '38', 'groupId': 'BG008'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '23', 'groupId': 'BG007'}, {'value': '47', 'groupId': 'BG008'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants treated with at least 1 dose'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-30', 'size': 1643880, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-09T20:46', 'hasProtocol': True}, {'date': '2020-05-30', 'size': 434559, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-09-09T20:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Uncontrolled, open label, non-randomized, Enrollment in the order of confirmation of eligibility, Escalating doses of study drug in sequential patient cohorts (Phase 1a). Uncontrolled, open label, non-randomised. Enrollment into three individual Phase 2a study cohorts'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'whyStopped': 'lack of efficacy', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-23', 'studyFirstSubmitDate': '2017-02-06', 'resultsFirstSubmitDate': '2021-09-10', 'studyFirstSubmitQcDate': '2017-03-22', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-23', 'studyFirstPostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1 Dose Escalation: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) in Cycle 1', 'timeFrame': 'Cycle 1 during Dose Escalation (ie the first 3 weeks of dosing)', 'description': 'Any of the following toxicities, if judged to be associated with study, were considered a DLT:\n\n1. Evidence of pulmonary fibrosis\n2. G3 non-hematologic toxicity regardless of duration with the exceptions of:\n\n * G3 nausea, vomiting, diarrhea, or fatigue lasting \\< 2 days\n * G3 asymptomatic electrolyte abnormalities lasting \\< 3 days not considered clinically relevant\n3. AST and/or ALT elevation \\> 3 x ULN with total bilirubin \\> 2 x ULN without initial findings of cholestasis, that cannot be explained by other factors\n4. Any G4 non-hematologic toxicity with the exception of:\n\n • G4 asymptomatic electrolyte abnormalities lasting \\< 7 days not considered clinically significant\n5. Neutropenia that is:\n\n * \\> G3 and associated with fever\n * G4 and sustained (ANC \\< 500 per mm3, duration \\> 5 days)\n6. Thrombocytopenia that is:\n\n * G3 with clinically significant hemorrhage or requirement for transfusion\n * G4 (platelets \\< 25,000 per mm3)\n7. Inability to complete Cycle 1 at the assigned dose'}, {'measure': 'Phase 2a: Number of Participants With Best Overall Response by RECIST 1.1', 'timeFrame': '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', 'description': 'Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening and every 2 cycles during study treatment.\n\nProgressive 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). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable 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. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non- target) must have reduction in short axis to \\< 10 mm.'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumor, Adult', 'Triple Negative Breast Cancer', 'Head and Neck Squamous Cell Carcinoma', 'Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Approximately 90 male and female patients with documented solid tumor malignancies of epithelial origin that are locally advanced or metastatic, and either refractory to standard therapy or for whom no standard therapy is available, will be entered into this Phase 1a/2a, multicenter, open-label, dose-escalation, cohort study of AVID100. Phase 2a will include evaluation of patient with EGFR-overexpressing squamous histology non-small cell lung cancer, squamous cell carcinoma of the head and neck, and triple negative breast cancer', 'detailedDescription': 'On Day 1 of study, patients will receive study drug administered by 2-hour IV infusion. AVID100 will be administered once every 3 weeks (Q3W) with administration on Day 1 of the first week, followed by a 3-week recovery period. In Phase 2a AVID100 will be administered at a dose of 220 mg/m2.\n\nEvidence of progressive disease at any point in the study will necessitate withdrawal of the patient from further participation so that alternative management of their malignancy may be considered. All patients will be followed to further evaluate safety as well as evidence of the anti-tumor effects of AVID100 in these selected patient populations. If anti-tumor activity is observed additional patients may be added to the planned Phase 2a patient populations to further characterize these effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (Phase 1):\n\n1. Patients with a documented (histologically- or cytologically-proven) solid tumor epithelial carcinoma that is locally advanced or metastatic\n2. Patients with a malignancy that is either refractory to standard therapy, or for which no standard therapy is available\n3. Patients with a malignancy that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor\n4. Phase 1a Dose-Escalation Cohorts: Patients with measurable or non-measurable disease according to RECIST, v1.1 criteria. To include patients reasonably likely to express EGFR.\n\nInclusion Criteria (Phase 2a)\n\n1. Patients with measurable disease according to RECIST, v1.1 criteria.\n2. Patients with triple negative breast cancer who are either EGFR 2+ or EGFR 3+ by validated IHC assay.\n3. Patients with squamous non-small cell lung cancer who are EGFR 3+ by validated IHC assay.\n4. Patients with squamous cell carcinoma of the head and neck who are EGFR 3+ by validated IHC assay.\n5. Patients whose malignancy is either refractory to standard therapy, or for which no standard therapy is available\n6. Patients whose malignancy is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor\n\nPatients to be Excluded (patients must not meet any of the following criteria Phase 1 only)\n\n1. Women who are pregnant or lactating. Women of child-bearing potential (WOCBP) and fertile men with WOCBP partner(s), not using and not willing to use a medically effective method of contraception.\n2. Patients with known central nervous system (CNS) or leptomeningeal metastases, or spinal cord compression not controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS involvement for which treatment is required\n3. Patients with a malignancy other than that of epithelial origin\n4. Patients with hematologic abnormalities at baseline\n5. Patients with a significant cardiovascular disease or condition\n6. Patients with a significant ocular disease or condition\n7. Patients with a significant pulmonary disease or condition\n8. History of pneumonia within 6 months prior to the first study drug administration\n9. Patients with significant gastrointestinal (GI) abnormalities\n10. Patients with non-healing wounds on any part of the body\n\nPatients to be Excluded (patients must not meet any of the following criteria Phase 2a only)\n\n1. Women who are pregnant or lactating. Women of child-bearing potential (WOCBP) and fertile men with WOCBP partner(s), not using and not willing to use a medically effective method of contraception.\n2. Patients with known central nervous system (CNS) or leptomeningeal metastases, or spinal cord compression not controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS involvement for which treatment is required\n3. Patients with a malignancy other than EGFR-overexpressing triple negative breast cancer, squamous histology non-small cell lung cancer, or squamous cell carcinoma of the head and neck.\n4. Patients with hematologic abnormalities at baseline\n5. Patients with a significant cardiovascular disease or condition\n6. Patients with a significant ocular disease or condition\n7. Patients with a significant pulmonary disease or condition\n8. History of pneumonia within 6 months prior to the first study drug administration\n9. Patients with significant gastrointestinal (GI) abnormalities\n10. Patients with non-healing wounds on any part of the body\n11. Patients without measurable disease according to RECIST v1.1\n12. Patients with an active second malignancy within the last 2 years prior to entry\n\nDrugs and Other Treatments to be Excluded\n\n1. Any antineoplastic agent for the primary malignancy (standard or investigational), without delayed toxicity, within 4 weeks, 5 plasma half-lives, or twice the duration of the biological effect, whichever is shortest, prior to first study drug administration and during study with the exception of: Nitrosoureas and nitrogen mustard within 6 weeks prior to first study drug administration and during study\n2. Any other investigational treatments during study. This includes participation in any medical device or other therapeutic intervention clinical trials.\n3. Radiotherapy for target lesions within 4 weeks prior to first study drug administration and during study\n4. Herbal preparations or related over-the-counter (OTC) preparations/supplements containing herbal ingredients aimed at treating the underlying malignancy within 2 weeks prior to first study drug administration and during study\n5. Strong inhibitors and/or inducers of cytochrome P450 (CYP) isoenzyme 3A4 within 2 weeks prior to first study drug administration and during study\n6. Immunosuppressive or systemic hormonal therapy within 2 weeks prior to first study drug administration and during study.\n7. Prophylactic use of hematopoietic growth factors within 1 week prior to first study drug administration and during Cycle 1 of study; thereafter prophylactic use of growth factors is allowed as clinically indicated'}, 'identificationModule': {'nctId': 'NCT03094169', 'briefTitle': 'AVID100 in Advanced Epithelial Carcinomas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Formation Biologics'}, 'officialTitle': 'Phase 1a/2a Dose Escalation Trial to Determine Safety, Tolerance, MTD, and Preliminary Antineoplastic Activity of AVID100, in Patients With Advanced or Metastatic Solid Tumors of Epithelial Origin', 'orgStudyIdInfo': {'id': 'AVID100-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose escalation', 'description': 'Minimum of 1 to 3 patients per dose cohort; approximately 4 dose cohorts to be evaluated to establish the Maximum tolerated dose.', 'interventionNames': ['Drug: AVID100 IV']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2a Triple Negative Breast Cancer', 'description': 'Addition of up to 15 patients in each of 2 subpopulations of patients with triple negative breast cancer (30 total). One group of 15 patients will have 3+ EGFR over-expression. The second group will have 2+ EGFR over-expression.', 'interventionNames': ['Drug: AVID100 IV']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2a Head and Neck Carcinoma', 'description': 'Addition of 15 patients with squamous head and neck carcinoma. Patients will have 3+ EGFR over-expression.', 'interventionNames': ['Drug: AVID100 IV']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2a Non-Small Cell Lung Carcinoma', 'description': 'Addition of 15 patients with squamous histology non-small cell lung carcinoma. Patients will have 3+ EGFR over-expression', 'interventionNames': ['Drug: AVID100 IV']}], 'interventions': [{'name': 'AVID100 IV', 'type': 'DRUG', 'description': 'AVID100 is administered once every 3 weeks', 'armGroupLabels': ['Dose escalation', 'Phase 2a Head and Neck Carcinoma', 'Phase 2a Non-Small Cell Lung Carcinoma', 'Phase 2a Triple Negative Breast Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'START Midwest', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The Tisch Cancer Institute-Mt. Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology Midtown', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology-Baylor -Charles A. Sammons Cancer Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78503', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology McAllen', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology NE San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '75702', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology Tyler', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}], 'overallOfficials': [{'name': 'Nehal Lakhani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'START Midwest'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Formation Biologics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}