Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-26 @ 7:45 PM
Study NCT ID:
NCT03954704
Status:
TERMINATED
Last Update Posted:
2023-11-21
First Post:
2019-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Dalutrafusp Alfa (Formerly GS-1423) in Participants With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GileadClinicalTrials@gilead.com', 'phone': '1-833-445-3230 (GILEAD-0)', 'title': 'Gilead Clinical Study Information Center', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Because the study was terminated after enrolling only 22 participants in the dose-escalation stage (Phase 1a Part A), planned analysis was not conducted for Phase 1a Part B, and Phase 1b.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months', 'description': 'Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.\n\nAll-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg', 'description': 'GS-1423 0.3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg', 'description': 'GS-1423 1 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg', 'description': 'GS-1423 3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg', 'description': 'GS-1423 10 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg', 'description': 'GS-1423 20 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg', 'description': 'GS-1423 30 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 2, 'seriousNumAffected': 4}, {'id': 'EG006', 'title': 'Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg', 'description': 'GS-1423 45 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, 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{'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Peripheral embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Covid-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Aortic embolus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase 1a Part A: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs), Graded Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)', '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': '5', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg', 'description': 'GS-1423 0.3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG001', 'title': 'Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg', 'description': 'GS-1423 1 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG002', 'title': 'Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg', 'description': 'GS-1423 3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG003', 'title': 'Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg', 'description': 'GS-1423 10 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG004', 'title': 'Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg', 'description': 'GS-1423 20 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG005', 'title': 'Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg', 'description': 'GS-1423 30 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG006', 'title': 'Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg', 'description': 'GS-1423 45 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}], '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': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28 days', 'description': 'DLT was defined as: Grade 3 thrombocytopenia with bleeding; Grade ≥ 3 febrile neutropenia; any Grade 4 hematologic laboratory abnormalities/adverse events (AEs) (except Grade 4 lymphopenia and anaemia, Grade 4 neutropenia lasting ≤ 7 days with no fever); Grade 4 non-hematologic AEs; any ≥Grade 2 uveitis, blurred vision, eye pain, and/or reduction of visual acuity that did not respond to topical therapy and did not improve to Grade 1 severity within 2 weeks of topical therapy initiation or required systemic treatment; Grade 3 non-hematologic AEs; any other non-immune-related Grade 3 AE (except any Grade 3 endocrinopathy; Grade 3 AE of tumor flare; transient \\[≤ 3 days\\] Grade 3 fatigue, local reactions, headache, nausea, emesis, or diarrhea and/or resolved to Grade ≤ 1; transient Grade 3 flu-like symptoms or fever); inability to receive first 2 doses of GS-1423 or \\> 2-week delay in starting next cycle of therapy due to a treatment-related toxicity; Grade 5 event (death).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The DLT-Evaluable Analysis Set included all participants who were enrolled for dose escalation, received the protocol-specified treatment, and completed safety procedures through Day 28 (inclusive) or experienced a DLT prior to Day 28.'}, {'type': 'SECONDARY', 'title': 'Phase 1a Part A: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)', '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': '7', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg', 'description': 'GS-1423 0.3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG001', 'title': 'Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg', 'description': 'GS-1423 1 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG002', 'title': 'Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg', 'description': 'GS-1423 3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG003', 'title': 'Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg', 'description': 'GS-1423 10 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG004', 'title': 'Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg', 'description': 'GS-1423 20 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG005', 'title': 'Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg', 'description': 'GS-1423 30 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG006', 'title': 'Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg', 'description': 'GS-1423 45 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '100.0', 'groupId': 'OG005'}, {'value': '100.0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to permanent withdrawal of GS-1423 (maximum duration: 26.3 weeks) plus 30 days', 'description': 'An AE was any untoward medical occurrence in a participant administered the study drug, which did not necessarily have a causal relationship with the treatment. An AE could therefore, be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Adverse events might also include pretreatment or posttreatment complications that occurred as a result of protocol-specified procedures or special situations. Preexisting events that increased in severity or change in nature during or as a consequence of participation in the study were also considered AEs. TEAEs were AEs with onset dates on or after the first dose of study drug GS-1423 and up to 30 days after permanent withdrawal of GS-1423.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Phase 1a Part A: Percentage of Participants With Treatment-Emergent Grade 3 or 4 Laboratory Abnormalities', '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': '7', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg', 'description': 'GS-1423 0.3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG001', 'title': 'Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg', 'description': 'GS-1423 1 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG002', 'title': 'Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg', 'description': 'GS-1423 3 mg/kg solution of body weight, for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG003', 'title': 'Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg', 'description': 'GS-1423 10 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG004', 'title': 'Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg', 'description': 'GS-1423 20 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG005', 'title': 'Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg', 'description': 'GS-1423 30 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG006', 'title': 'Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg', 'description': 'GS-1423 45 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}], 'classes': [{'title': 'Hematology', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '33.3', 'groupId': 'OG004'}, {'value': '14.3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Serum Chemistry', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '33.3', 'groupId': 'OG004'}, {'value': '14.3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Coagulation', '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': '0', 'groupId': 'OG006'}]}]}, {'title': 'Endocrine Function Tests', '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': '0', 'groupId': 'OG006'}]}]}, {'title': 'Urinalysis', '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': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to permanent withdrawal of GS-1423 (maximum duration: 26.3 weeks) plus 30 days', 'description': 'Severity was graded per NCI CTCAE v5.0. Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening or disabling, Grade 5: Death related to AE.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Phase 1a Part A: Percentage of Participants With Shift in Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) From Baseline to Overall Study', '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': '7', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg', 'description': 'GS-1423 0.3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG001', 'title': 'Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg', 'description': 'GS-1423 1 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG002', 'title': 'Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg', 'description': 'GS-1423 3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG003', 'title': 'Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg', 'description': 'GS-1423 10 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG004', 'title': 'Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg', 'description': 'GS-1423 20 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG005', 'title': 'Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg', 'description': 'GS-1423 30 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG006', 'title': 'Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg', 'description': 'GS-1423 45 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}], 'classes': [{'title': 'Normal baseline - Normal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Normal baseline - Abnormal NCS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '66.7', 'groupId': 'OG004'}, {'value': '71.4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Normal baseline - Abnormal CS', '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': '0', 'groupId': 'OG006'}]}]}, {'title': 'Abnormal NCS Baseline - Normal', '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': '0', 'groupId': 'OG006'}]}]}, {'title': 'Abnormal NCS Baseline - Abnormal NCS', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '33.3', 'groupId': 'OG004'}, {'value': '28.6', 'groupId': 'OG005'}, {'value': '100.0', 'groupId': 'OG006'}]}]}, {'title': 'Abnormal NCS Baseline - Abnormal CS', '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': '0', 'groupId': 'OG006'}]}]}, {'title': 'Abnormal CS Baseline - Normal', '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': '0', 'groupId': 'OG006'}]}]}, {'title': 'Abnormal CS Baseline - Abnormal NCS', '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': '0', 'groupId': 'OG006'}]}]}, {'title': 'Abnormal CS Baseline - Abnormal CS', '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': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to permanent withdrawal of GS-1423 (maximum duration: 26.3 weeks) plus 30 days', 'description': 'The Baseline value was the last available value collected on or prior to first dose of study drug. Percentages were based on participants with values available at both baseline and postbaseline.\n\nNCS = Non-clinical significance; CS = Clinical significance.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Phase 1a Part A: Pharmacokinetic (PK) Parameter: AUCtau of GS-1423', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg', 'description': 'GS-1423 0.3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG001', 'title': 'Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg', 'description': 'GS-1423 1 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG002', 'title': 'Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg', 'description': 'GS-1423 3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG003', 'title': 'Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg', 'description': 'GS-1423 10 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG004', 'title': 'Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg', 'description': 'GS-1423 20 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG005', 'title': 'Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg', 'description': 'GS-1423 30 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG006', 'title': 'Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg', 'description': 'GS-1423 45 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1476.9', 'spread': '759.84', 'groupId': 'OG002'}, {'value': '5311.8', 'spread': '595.77', 'groupId': 'OG003'}, {'value': '33530.9', 'spread': '1646.22', 'groupId': 'OG004'}, {'value': '51593.2', 'spread': '16313.20', 'groupId': 'OG005'}, {'value': '64856.3', 'spread': '9814.95', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1711.9', 'spread': '1486.08', 'groupId': 'OG002'}, {'value': '28558.0', 'groupId': 'OG004'}, {'value': '65368.1', 'spread': '5469.82', 'groupId': 'OG005'}, {'value': '74097.0', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 and Cycle 4: Day 1 (Predose, end of infusion, 2 and 6 hours post start of infusion); Days 2, 3, 5, and 8 (additionally at Day 15 in Cycle 4)', 'description': 'AUCtau was defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).', 'unitOfMeasure': 'µg*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK Analysis Set (all enrolled participants who received at least 1 dose of study drug and had at least 1 non-missing postdose concentration value reported by the PK laboratory) with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Phase 1a Part A: Percentage of Participants Who Developed Anti-Drug Antibodies (ADAs)', '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': '7', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg', 'description': 'GS-1423 0.3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG001', 'title': 'Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg', 'description': 'GS-1423 1 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG002', 'title': 'Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg', 'description': 'GS-1423 3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG003', 'title': 'Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg', 'description': 'GS-1423 10 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG004', 'title': 'Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg', 'description': 'GS-1423 20 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG005', 'title': 'Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg', 'description': 'GS-1423 30 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'OG006', 'title': 'Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg', 'description': 'GS-1423 45 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '14.3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'During the Treatment', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}, {'value': '66.7', 'groupId': 'OG003'}, {'value': '66.7', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '33.3', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '66.7', 'groupId': 'OG003'}, {'value': '33.3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '33.3', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 3 Day 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '66.7', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 4 Day 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '33.3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 4 Day 15', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '33.3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 6 Day 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': '30-Day Follow-Up', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '33.3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Post Treatment Follow-Up (3 months)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '33.0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, during the treatment (maximum duration: 26.3 weeks), Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 4 Day 15, Cycle 6 Day 1, 30-day follow-up (30 days after discontinuation of GS-1423), post treatment follow-up (3 months)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Immunogenicity Analysis Set included all participants in the Safety Analysis Set who have at least 1 nonmissing postdose ADA status reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg', 'description': 'GS-1423 0.3 mg/kg of body weight, solution for intravenous (IV) infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'FG001', 'title': 'Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg', 'description': 'GS-1423 1 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'FG002', 'title': 'Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg', 'description': 'GS-1423 3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'FG003', 'title': 'Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg', 'description': 'GS-1423 10 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'FG004', 'title': 'Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg', 'description': 'GS-1423 20 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'FG005', 'title': 'Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg', 'description': 'GS-1423 30 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'FG006', 'title': 'Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg', 'description': 'GS-1423 45 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}], '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': '8'}, {'groupId': 'FG006', 'numSubjects': '3'}]}, {'type': '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': '0'}]}, {'type': 'NOT 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': '8'}, {'groupId': 'FG006', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', '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'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Enrolled but not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in United States. The first participant was screened on 03 June 2019. The last study visit occurred on 15 April 2021.', 'preAssignmentDetails': 'The study was discontinued prior to initiation of Phase 1a Part B and Phase 1b. Therefore, data are reported for only Phase 1a Part A.'}, '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': '7', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg', 'description': 'GS-1423 0.3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'BG001', 'title': 'Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg', 'description': 'GS-1423 1 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'BG002', 'title': 'Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg', 'description': 'GS-1423 3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'BG003', 'title': 'Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg', 'description': 'GS-1423 10 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'BG004', 'title': 'Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg', 'description': 'GS-1423 20 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'BG005', 'title': 'Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg', 'description': 'GS-1423 30 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'BG006', 'title': 'Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg', 'description': 'GS-1423 45 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '70', 'spread': '8.7', 'groupId': 'BG002'}, {'value': '70', 'spread': '11.6', 'groupId': 'BG003'}, {'value': '62', 'spread': '7.4', 'groupId': 'BG004'}, {'value': '57', 'spread': '15.8', 'groupId': 'BG005'}, {'value': '71', 'spread': '7.2', 'groupId': 'BG006'}, {'value': '64', 'spread': '12.0', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '15', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '14', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}]}]}], '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'}]}, {'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': '0', 'groupId': 'BG007'}]}, {'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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '18', 'groupId': 'BG007'}]}, {'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'}]}, {'title': 'Unknown or Not Reported', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-29', 'size': 5704910, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-07-25T15:29', 'hasProtocol': True}, {'date': '2021-07-13', 'size': 2262010, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-07-25T15:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'whyStopped': 'The decision to discontinue the study was made based on the totality of the clinical, pharmacokinetic, and pharmacodynamic findings. No safety concerns were observed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-10', 'studyFirstSubmitDate': '2019-05-15', 'resultsFirstSubmitDate': '2023-02-10', 'studyFirstSubmitQcDate': '2019-05-15', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-10', 'studyFirstPostDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1a Part A: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs), Graded Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)', 'timeFrame': 'Baseline up to 28 days', 'description': 'DLT was defined as: Grade 3 thrombocytopenia with bleeding; Grade ≥ 3 febrile neutropenia; any Grade 4 hematologic laboratory abnormalities/adverse events (AEs) (except Grade 4 lymphopenia and anaemia, Grade 4 neutropenia lasting ≤ 7 days with no fever); Grade 4 non-hematologic AEs; any ≥Grade 2 uveitis, blurred vision, eye pain, and/or reduction of visual acuity that did not respond to topical therapy and did not improve to Grade 1 severity within 2 weeks of topical therapy initiation or required systemic treatment; Grade 3 non-hematologic AEs; any other non-immune-related Grade 3 AE (except any Grade 3 endocrinopathy; Grade 3 AE of tumor flare; transient \\[≤ 3 days\\] Grade 3 fatigue, local reactions, headache, nausea, emesis, or diarrhea and/or resolved to Grade ≤ 1; transient Grade 3 flu-like symptoms or fever); inability to receive first 2 doses of GS-1423 or \\> 2-week delay in starting next cycle of therapy due to a treatment-related toxicity; Grade 5 event (death).'}], 'secondaryOutcomes': [{'measure': 'Phase 1a Part A: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'First dose date up to permanent withdrawal of GS-1423 (maximum duration: 26.3 weeks) plus 30 days', 'description': 'An AE was any untoward medical occurrence in a participant administered the study drug, which did not necessarily have a causal relationship with the treatment. An AE could therefore, be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Adverse events might also include pretreatment or posttreatment complications that occurred as a result of protocol-specified procedures or special situations. Preexisting events that increased in severity or change in nature during or as a consequence of participation in the study were also considered AEs. TEAEs were AEs with onset dates on or after the first dose of study drug GS-1423 and up to 30 days after permanent withdrawal of GS-1423.'}, {'measure': 'Phase 1a Part A: Percentage of Participants With Treatment-Emergent Grade 3 or 4 Laboratory Abnormalities', 'timeFrame': 'First dose date up to permanent withdrawal of GS-1423 (maximum duration: 26.3 weeks) plus 30 days', 'description': 'Severity was graded per NCI CTCAE v5.0. Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening or disabling, Grade 5: Death related to AE.'}, {'measure': 'Phase 1a Part A: Percentage of Participants With Shift in Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) From Baseline to Overall Study', 'timeFrame': 'First dose date up to permanent withdrawal of GS-1423 (maximum duration: 26.3 weeks) plus 30 days', 'description': 'The Baseline value was the last available value collected on or prior to first dose of study drug. Percentages were based on participants with values available at both baseline and postbaseline.\n\nNCS = Non-clinical significance; CS = Clinical significance.'}, {'measure': 'Phase 1a Part A: Pharmacokinetic (PK) Parameter: AUCtau of GS-1423', 'timeFrame': 'Cycle 1 and Cycle 4: Day 1 (Predose, end of infusion, 2 and 6 hours post start of infusion); Days 2, 3, 5, and 8 (additionally at Day 15 in Cycle 4)', 'description': 'AUCtau was defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).'}, {'measure': 'Phase 1a Part A: Percentage of Participants Who Developed Anti-Drug Antibodies (ADAs)', 'timeFrame': 'Baseline, during the treatment (maximum duration: 26.3 weeks), Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 4 Day 15, Cycle 6 Day 1, 30-day follow-up (30 days after discontinuation of GS-1423), post treatment follow-up (3 months)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '36746510', 'type': 'BACKGROUND', 'citation': 'Tolcher AW, Gordon M, Mahoney KM, Seto A, Zavodovskaya M, Hsueh CH, Zhai S, Tarnowski T, Jurgensmeier JM, Stinson S, Othman AA, Chen T, Strauss J. Phase 1 first-in-human study of dalutrafusp alfa, an anti-CD73-TGF-beta-trap bifunctional antibody, in patients with advanced solid tumors. J Immunother Cancer. 2023 Feb;11(2):e005267. doi: 10.1136/jitc-2022-005267.'}], 'seeAlsoLinks': [{'url': 'https://www.gileadclinicaltrials.com/study/?id=GS-US-505-5452', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'For Phase 1a Part A, the primary objectives are to assess safety and tolerability and to define the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of dalutrafusp alfa (formerly GS-1423) monotherapy in participants with advanced solid tumors.\n\nFor Phase 1a Part B, the primary objective is to assess safety and tolerability of dalutrafusp alfa monotherapy in participants with advanced solid tumors.\n\nFor Phase 1b Cohort 1 safety run-in, the primary objective is to assess safety and tolerability and to define the DLT and MTD or RP2D of dalutrafusp alfa in combination with a chemotherapy regimen in participants with advanced gastric or gastroesophageal junction adenocarcinoma.\n\nFor Phase 1b Cohort 1 post safety run-in, the primary objective is to assess the preliminary efficacy of dalutrafusp alfa in combination with a chemotherapy regimen in participants with advanced gastric or gastroesophageal junction adenocarcinoma, as assessed by the confirmed objective response rate (ORR).\n\nFor Phase 1b Cohort 2, the primary objective is to assess safety and tolerability of dalutrafusp alfa monotherapy in participants with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Diagnosis:\n\n * For Phase 1a and Phase 1b Cohort 2, have a histologically or cytologically confirmed diagnosis of a locally advanced or metastatic solid tumor for which no standard therapy is available (per local guidance) or standard therapy has failed, or\n * For Phase 1b Cohort 1, have histologically or cytologically confirmed unresectable, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma who have not previously received systemic therapy for advanced disease\n* Measurable disease: Have measurable disease on imaging based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1\n* Have a life expectancy of at least 3 months and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\nKey Exclusion Criteria:\n\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 3 weeks of the first dose of treatment\n* Has persisting toxicity related to prior therapy of National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE) Grade \\>1 severity\n* Is expected to require any other form of systemic or localized anticancer therapy while on trial (including maintenance therapy with another agent, radiation therapy, and/or surgical resection)\n* Has concurrent active malignancy other than nonmelanoma skin cancer, carcinoma in situ of the cervix or superficial bladder cancer who has undergone potentially curative therapy with no evidence of disease. Individuals with other previous malignancies are eligible if disease-free for \\>2 years\n* Has a known central nervous system metastasis(es), unless metastases are treated and stable and the individual does not require systemic corticosteroids for management of CNS symptoms at least 7 days prior to study treatment. Individuals with history of carcinomatous meningitis are excluded regardless of clinical stability.\n* Has active or history of autoimmune disease that has required systemic treatment within 2 years of the start of trial treatment\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT03954704', 'briefTitle': 'Study of Dalutrafusp Alfa (Formerly GS-1423) in Participants With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 1a/1b Study of GS-1423, an Anti-CD73-TGFβ-Trap Bifunctional Antibody, as Monotherapy or in Combination With a Chemotherapy Regimen in Subjects With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'GS-US-505-5452'}, 'secondaryIdInfos': [{'id': '2019-004938-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1a, Part A - Dose Escalation', 'description': 'Part A will consist of dose escalation by an accelerated dosing design and a 3+3 dose escalation scheme. Participants will receive escalating dose levels dalutrafusp alfa of up to 45 mg/kg on Day 1 of each 2-week cycle (Q2W) until the participant meets study treatment discontinuation criteria or for up to 1 year.', 'interventionNames': ['Drug: Dalutrafusp alfa']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1a, Part B - Flat Dose Regimen', 'description': 'Part B will consist of 3 adaptive cohorts. Based on PK, pharmacodynamics, and safety results from the Part A study, participants will be administered a flat dose of dalutrafusp alfa on Day 1 of each cycle QW, Q2W and/or every 3 weeks (Q3W) until the participant meets study treatment discontinuation criteria or for up to 1 year.', 'interventionNames': ['Drug: Dalutrafusp alfa']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b, Cohort 1 (Gastric Cancer)', 'description': 'Safety run-in: A standard 3+3 dose escalation design will be used to determine the DLT and MTD or RP2D of dalutrafusp alfa in combination with mFOLFOX6. The planned starting dose of dalutrafusp alfa will be targeted to achieve the exposure at -1 dose of RP2D monotherapy (Q2W) determined from Phase 1a. Dalutrafusp alfa will be administered in combination with mFOLFOX6.\n\nPost safety run-in: Approximately 70 participants will be enrolled to receive dalutrafusp alfa at the dose level determined from the safety run-in period, in combination with mFOLFOX6 regimen.\n\nParticipants will receive dalutrafusp alfa on Day 1 of each 14-day cycle up to 2 years until PD, or unacceptable toxicity, substantial noncompliance with study procedures or study drug, study discontinuation or withdrawal from study. Participants will also receive mFOLFOX6 regimen Q2W for up to 12 cycles.', 'interventionNames': ['Drug: Dalutrafusp alfa', 'Drug: mFOLFOX6 Regimen']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b, Cohort 2 (Paired Biopsy)', 'description': 'Participants will receive dalutrafusp alfa at the dose level determined from Phase 1a Q2W until the participants meets study treatment discontinuation criteria or for up to 1 year.', 'interventionNames': ['Drug: Dalutrafusp alfa']}], 'interventions': [{'name': 'Dalutrafusp alfa', 'type': 'DRUG', 'otherNames': ['GS-1423'], 'description': 'Administered intravenously', 'armGroupLabels': ['Phase 1a, Part A - Dose Escalation', 'Phase 1b, Cohort 1 (Gastric Cancer)', 'Phase 1b, Cohort 2 (Paired Biopsy)']}, {'name': 'mFOLFOX6 Regimen', 'type': 'DRUG', 'description': 'Chemotherapy regimen of oxaliplatin, 5-fluorouracil \\[5-FU\\], and leucovorin', 'armGroupLabels': ['Phase 1b, Cohort 1 (Gastric Cancer)']}, {'name': 'Dalutrafusp alfa', 'type': 'DRUG', 'otherNames': ['GS-1423'], 'description': 'Administered intravenously', 'armGroupLabels': ['Phase 1a, Part B - Flat Dose Regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Scottsdale Healthcare Hospitals d/b/a HonorHealth', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Mary Crowley Cancer Research', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'NEXT Oncology', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}