Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-31 @ 1:46 AM
Study NCT ID:
NCT04945733
Status:
TERMINATED
Last Update Posted:
2024-09-19
First Post:
2021-06-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Amivantamab in Participants With Previously Treated Advanced or Metastatic Gastric or Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718215', 'term': 'amivantamab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Executive Medical Director', 'organization': 'Janssen Pharmaceutical K.K.'}, 'certainAgreement': {'otherDetails': 'If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was planned to be conducted in 2 cohorts: Phase 2a cohorts (including Phase 2a extension cohort) and Phase 2b expansion cohort. However, due to study termination, no participants were enrolled in Phase 2a extension and Phase 2b cohorts. Hence results were only presented for Phase 2a cohorts. Phase 2b specific outcome measure (overall survival) were not included in the results.'}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality: From screening up to 30 days after last dose of study drug (up to 10 months); Serious AEs and Other AEs: From start of the treatment (Day 1) up to 30 days after last dose of study drug (up to 9 months)', 'description': 'The safety analysis set included all participants who took at least 1 dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic gastric/gastroesophageal junction cancer (GC) exhibiting varying degrees of epidermal growth factor receptor (EGFR), tyrosine-protein kinase mesenchymal-epithelial transition (MET), or both as determined by immunohistochemistry (IHC) received amivantamab 1050 milligrams (mg) for body weight less than (\\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg/1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 28, 'seriousNumAtRisk': 29, 'deathsNumAffected': 5, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 30, 'seriousNumAtRisk': 30, 'deathsNumAffected': 2, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)', 'description': 'Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight \\<80 kg or 2100 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight \\<80 kg or 1750 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Hepatic Function Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Liver Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Infusion Related Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Procedural Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Eastern Cooperative Oncology Group Performance Status Worsened', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Cancer Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Decubitus Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Dermatitis Acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Skin Fissures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}], 'seriousEvents': [{'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Adrenal Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Gastrointestinal Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Oesophageal Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Disease Progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Bile Duct Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Pneumonia Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Retroperitoneal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Kidney Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Radiation Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Eastern Cooperative Oncology Group Performance Status Worsened', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Tumour Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Interstitial Lung Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Tracheal Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic gastric/gastroesophageal junction cancer (GC) exhibiting varying degrees of epidermal growth factor receptor (EGFR), tyrosine-protein kinase mesenchymal-epithelial transition (MET), or both as determined by immunohistochemistry (IHC) received amivantamab 1050 milligrams (mg) for body weight less than (\\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg/1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG001', 'title': 'Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG002', 'title': 'Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)', 'description': 'Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight \\<80 kg or 2100 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight \\<80 kg or 1750 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '21.9'}, {'value': '10.7', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '28.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '84.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of the treatment (Day 1) up to 30 days after the last dose of study drug (up to 9 months)', 'description': 'ORR was defined as the percentage of participants who achieved a confirmed complete response (CR) or partial response (PR) as determined by investigator per RECIST version 1.1. As per RECIST version 1.1, CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (\\<)10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-progressive disease (PD). For non-target lesions, PD: unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response evaluable analysis set included all participants who received at least 1 dose of study treatment, met all eligibility criteria for the study and had a baseline and at least 1 post-baseline efficacy disease assessments, or had disease progression/death due to disease progression prior to the first post-baseline disease assessment.'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR) Per RECIST Version 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic gastric/gastroesophageal junction cancer (GC) exhibiting varying degrees of epidermal growth factor receptor (EGFR), tyrosine-protein kinase mesenchymal-epithelial transition (MET), or both as determined by immunohistochemistry (IHC) received amivantamab 1050 milligrams (mg) for body weight less than (\\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg/1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG001', 'title': 'Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG002', 'title': 'Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)', 'description': 'Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight \\<80 kg or 2100 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight \\<80 kg or 1750 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000', 'lowerLimit': '10.2', 'upperLimit': '48.4'}, {'value': '67.9', 'groupId': 'OG001', 'lowerLimit': '47.6', 'upperLimit': '84.1'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '15.8', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of the treatment (Day 1) up to 30 days after the last dose of study drug (up to 9 months)', 'description': 'DCR was defined as the percentage of participants achieving CR or PR or stable disease (SD) for at least 6 weeks as defined by RECIST version 1.1. As per RECIST version 1.1 CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \\<10 mm. PR was defined as \\>=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. For non-target lesions, PD: unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, and no appearance of new lesion(s).', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response evaluable analysis set included all participants who received at least 1 dose of study treatment, met all eligibility criteria for the study and had a baseline and at least 1 post-baseline efficacy disease assessments, or had disease progression/death due to disease progression prior to the first post-baseline disease assessment.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) as Per RECIST Version 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic gastric/gastroesophageal junction cancer (GC) exhibiting varying degrees of epidermal growth factor receptor (EGFR), tyrosine-protein kinase mesenchymal-epithelial transition (MET), or both as determined by immunohistochemistry (IHC) received amivantamab 1050 milligrams (mg) for body weight less than (\\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg/1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG001', 'title': 'Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG002', 'title': 'Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)', 'description': 'Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight \\<80 kg or 2100 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight \\<80 kg or 1750 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': "Here, 'NA' signifies that median, lower and upper limit of 95% confidence interval (CI) could not be calculated due to less number of participants with events.", 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.86', 'comment': "Here, 'NA' signifies that upper limit of 95% CI could not be calculated due to less number of participants with events.", 'groupId': 'OG001', 'lowerLimit': '2.79', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first documented response up to date of first documented PD or death (up to 9 months)', 'description': 'DOR was defined as time between date of first documented response (CR/PR) and date of first documented progression or death, whichever occurred first. CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes short axis measures \\<10 mm. PR was defined as \\>=30% decrease in sum of measures (tumor lesions-longest diameter and nodes-short axis) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. For non-target lesions, PD: unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. There was no participant who had event (CR/PR) in Phase 2a EC higher dose cohort, hence data could not be collected and analyzed for this cohort.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Response evaluable analysis set included all participants who received at least 1 dose of study treatment, met all eligibility criteria for study and had a baseline and at least 1 post-baseline efficacy disease assessments, or had disease progression/death due to disease progression prior to first post-baseline disease assessment. Here 'N' (overall number of participants analyzed) = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR) as Per RECIST Version 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic gastric/gastroesophageal junction cancer (GC) exhibiting varying degrees of epidermal growth factor receptor (EGFR), tyrosine-protein kinase mesenchymal-epithelial transition (MET), or both as determined by immunohistochemistry (IHC) received amivantamab 1050 milligrams (mg) for body weight less than (\\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg/1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG001', 'title': 'Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG002', 'title': 'Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)', 'description': 'Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight \\<80 kg or 2100 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight \\<80 kg or 1750 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.45', 'comment': "Here, 'NA' signifies that lower and upper limit of 95% CI could not be calculated due to less number of participants with events.", 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.41', 'comment': "Here, 'NA' signifies that upper limit of 95% CI could not be calculated due to less number of participants with events.", 'groupId': 'OG001', 'lowerLimit': '1.41', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study treatment until first documentation of CR or PR (up to 9 months)', 'description': 'TTR was defined as time from date of first amivantamab administration to date of achieving objective response (CR/PR) as assessed by investigator per RECIST v1.1 among participants who achieved objective response. Per RECIST v1.1, CR: disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \\<10 mm. PR: \\>=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. For non-target lesions, PD: unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. There was no participant who had event (CR/PR) in Phase 2a EC higher dose cohort, hence data could not be collected and analyzed for this cohort.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Response evaluable analysis set included all participants who received at least 1 dose of study treatment, met all eligibility criteria for study and had a baseline and at least 1 post-baseline efficacy disease assessments, or had disease progression/death due to disease progression prior to first post-baseline disease assessment. Here 'N' (overall number of participants analyzed) = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) as Per RECIST Version 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic gastric/gastroesophageal junction cancer (GC) exhibiting varying degrees of epidermal growth factor receptor (EGFR), tyrosine-protein kinase mesenchymal-epithelial transition (MET), or both as determined by immunohistochemistry (IHC) received amivantamab 1050 milligrams (mg) for body weight less than (\\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg/1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG001', 'title': 'Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG002', 'title': 'Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)', 'description': 'Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight \\<80 kg or 2100 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight \\<80 kg or 1750 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.45', 'groupId': 'OG000', 'lowerLimit': '1.41', 'upperLimit': '1.48'}, {'value': '4.11', 'groupId': 'OG001', 'lowerLimit': '2.10', 'upperLimit': '4.17'}, {'value': '2.99', 'comment': "Here, 'NA' signifies that upper limit of 95% CI could not be calculated due to less number of participants with events.", 'groupId': 'OG002', 'lowerLimit': '1.41', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From day of first dose (Day 1) until PD or death (up to 9 months)', 'description': 'PFS was defined as the time from the date of first dose of study drug until the date of objective disease progression or death (by any cause in the absence of progression), whichever comes first, based on investigator assessment using RECIST Version 1.1.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated analysis set included all participants who took at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic gastric/gastroesophageal junction cancer (GC) exhibiting varying degrees of epidermal growth factor receptor (EGFR), tyrosine-protein kinase mesenchymal-epithelial transition (MET), or both as determined by immunohistochemistry (IHC) received amivantamab 1050 milligrams (mg) for body weight less than (\\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg/1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG001', 'title': 'Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG002', 'title': 'Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)', 'description': 'Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight \\<80 kg or 2100 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight \\<80 kg or 1750 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of the treatment (Day 1) up to 30 days after last dose or start of new anticancer therapy, whichever occurred first (up to 9 months)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs was defined as AEs occurring at or after first dose of study drug up to 30 days after last dose or until the start of new anticancer therapy, whichever occurred first. TEAEs were graded according to NCI-CTCAE v5.0. Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe or medically significant but not immediately life-threatening; Grade 4- Life-threatening consequences; Grade 5- Death related to AE. All TEAEs including serious and non-serious events are reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants who took at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Serum Concentration (Cmax) for Amivantamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic gastric/gastroesophageal junction cancer (GC) exhibiting varying degrees of epidermal growth factor receptor (EGFR), tyrosine-protein kinase mesenchymal-epithelial transition (MET), or both as determined by immunohistochemistry (IHC) received amivantamab 1050 milligrams (mg) for body weight less than (\\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg/1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG001', 'title': 'Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG002', 'title': 'Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)', 'description': 'Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight \\<80 kg or 2100 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight \\<80 kg or 1750 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG003', 'title': 'Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic GC and EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '356', 'spread': '91.6', 'groupId': 'OG000'}, {'value': '370', 'spread': '78.2', 'groupId': 'OG001'}, {'value': '363', 'spread': '84.0', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '820', 'spread': '221', 'groupId': 'OG000'}, {'value': '866', 'spread': '196', 'groupId': 'OG001'}, {'value': '845', 'spread': '202', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0, 24, 26, 48, 72, 96 and 168 hours post-dose on Day 1 of Cycle 1; pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)', 'description': 'Cmax was defined as the maximum observed serum concentration of amivantamab. The concentrations of amivantamab were measured using a validated, specific, and sensitive enzyme-linked immunosorbent assay (ELISA) method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for Cmax was not collected and analyzed for Phase 2a EC higher dose cohort.', 'unitOfMeasure': 'Micrograms per milliliter (mcg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The pharmacokinetics (PK) analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline measurement. Here 'N' (overall number of participants analyzed) = participants evaluable for this outcome measure and 'n' (number analyzed) = refers to participants evaluable at specified time points."}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Serum Concentration (Tmax) for Amivantamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic gastric/gastroesophageal junction cancer (GC) exhibiting varying degrees of epidermal growth factor receptor (EGFR), tyrosine-protein kinase mesenchymal-epithelial transition (MET), or both as determined by immunohistochemistry (IHC) received amivantamab 1050 milligrams (mg) for body weight less than (\\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg/1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG001', 'title': 'Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG002', 'title': 'Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)', 'description': 'Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight \\<80 kg or 2100 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight \\<80 kg or 1750 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG003', 'title': 'Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic GC and EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28.42', 'groupId': 'OG000', 'lowerLimit': '27.02', 'upperLimit': '31.00'}, {'value': '29.65', 'groupId': 'OG001', 'lowerLimit': '28.80', 'upperLimit': '31.62'}, {'value': '29.23', 'groupId': 'OG003', 'lowerLimit': '27.02', 'upperLimit': '31.62'}]}]}, {'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.23', 'groupId': 'OG000', 'lowerLimit': '2.42', 'upperLimit': '24.63'}, {'value': '2.53', 'groupId': 'OG001', 'lowerLimit': '2.27', 'upperLimit': '4.53'}, {'value': '3.46', 'groupId': 'OG003', 'lowerLimit': '2.27', 'upperLimit': '24.63'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0, 24, 26, 48, 72, 96 and 168 hours post-dose on Day 1 of Cycle 1; pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)', 'description': 'Tmax was defined as the time to reach maximum observed serum concentration of amivantamab. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for Tmax was not collected and analyzed for Phase 2a EC higher dose cohort.', 'unitOfMeasure': 'Hours (h)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "The PK analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline measurement. Here 'N' (overall number of participants analyzed) = participants evaluable for this outcome measure and 'n' (number analyzed) = refers to participants evaluable at specified time points."}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time (0) to Time (168h) (AUC [0-168h]) for Amivantamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic gastric/gastroesophageal junction cancer (GC) exhibiting varying degrees of epidermal growth factor receptor (EGFR), tyrosine-protein kinase mesenchymal-epithelial transition (MET), or both as determined by immunohistochemistry (IHC) received amivantamab 1050 milligrams (mg) for body weight less than (\\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg/1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG001', 'title': 'Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG002', 'title': 'Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)', 'description': 'Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight \\<80 kg or 2100 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight \\<80 kg or 1750 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG003', 'title': 'Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic GC and EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '30990', 'spread': '8346', 'groupId': 'OG000'}, {'value': '31548', 'spread': '7854', 'groupId': 'OG001'}, {'value': '31269', 'spread': '7930', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0, 24, 26, 48, 72, 96 and 168 hours post-dose on Day 1 of Cycle 1 (each cycle was of 28 days)', 'description': 'AUC (0-168h) was defined as area under the serum concentration time-curve from time zero to the time point 168 hours. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for AUC (0-168h) was not collected and analyzed for Phase 2a EC higher dose cohort.', 'unitOfMeasure': 'micrograms*hours/milliliter (mcg*hr/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline measurement. Here 'N' (overall number of participants analyzed) refers to the participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Amivantamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic gastric/gastroesophageal junction cancer (GC) exhibiting varying degrees of epidermal growth factor receptor (EGFR), tyrosine-protein kinase mesenchymal-epithelial transition (MET), or both as determined by immunohistochemistry (IHC) received amivantamab 1050 milligrams (mg) for body weight less than (\\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg/1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG001', 'title': 'Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG002', 'title': 'Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)', 'description': 'Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight \\<80 kg or 2100 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight \\<80 kg or 1750 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG003', 'title': 'Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic GC and EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '137806', 'spread': '19006', 'groupId': 'OG000'}, {'value': '162171', 'spread': '45328', 'groupId': 'OG001'}, {'value': '154049', 'spread': '39369', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)', 'description': 'Area under the serum concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 336 hours was reported. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for AUCtau was not collected and analyzed for Phase 2a EC higher dose cohort.', 'unitOfMeasure': 'micrograms*hours/milliliter (mcg*hr/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline measurement. Here 'N' (overall number of participants analyzed) refers to the participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Phase 2a Gastric Cancer and Esophageal Cancer Cohorts: Serum Trough Concentrations (Ctrough) of Amivantamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic gastric/gastroesophageal junction cancer (GC) exhibiting varying degrees of epidermal growth factor receptor (EGFR), tyrosine-protein kinase mesenchymal-epithelial transition (MET), or both as determined by immunohistochemistry (IHC) received amivantamab 1050 milligrams (mg) for body weight less than (\\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg/1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG001', 'title': 'Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG002', 'title': 'Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic GC and EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}], 'classes': [{'title': 'Pre-dose Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '119', 'spread': '34.9', 'groupId': 'OG000'}, {'value': '136', 'spread': '45.1', 'groupId': 'OG001'}, {'value': '128', 'spread': '40.5', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '214', 'spread': '73.7', 'groupId': 'OG000'}, {'value': '222', 'spread': '74.6', 'groupId': 'OG001'}, {'value': '218', 'spread': '73.5', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '308', 'spread': '99.5', 'groupId': 'OG000'}, {'value': '342', 'spread': '77.4', 'groupId': 'OG001'}, {'value': '327', 'spread': '88.5', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose Cycle 2 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '231', 'spread': '85.6', 'groupId': 'OG000'}, {'value': '259', 'spread': '80.7', 'groupId': 'OG001'}, {'value': '250', 'spread': '82.0', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '166', 'spread': '86.6', 'groupId': 'OG000'}, {'value': '234', 'spread': '58.5', 'groupId': 'OG001'}, {'value': '217', 'spread': '70.3', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose Cycle 3 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '154', 'spread': '83.3', 'groupId': 'OG000'}, {'value': '210', 'spread': '87.1', 'groupId': 'OG001'}, {'value': '198', 'spread': '87.1', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '105', 'spread': '73.2', 'groupId': 'OG000'}, {'value': '236', 'spread': '82.8', 'groupId': 'OG001'}, {'value': '210', 'spread': '95.4', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose Cycle 4 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '139.0', 'spread': 'NA', 'comment': "Here, 'NA' signifies that standard deviation could not be calculated due to single evaluable participant.", 'groupId': 'OG000'}, {'value': '203', 'spread': '54.1', 'groupId': 'OG001'}, {'value': '198', 'spread': '54.8', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '122.3', 'spread': 'NA', 'comment': "Here, 'NA' signifies that standard deviation could not be calculated due to single evaluable participant.", 'groupId': 'OG000'}, {'value': '190', 'spread': '35.7', 'groupId': 'OG001'}, {'value': '173', 'spread': '44.7', 'groupId': 'OG002'}]}]}, {'title': 'Pre-dose Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '111.4', 'spread': 'NA', 'comment': "Here, 'NA' signifies that standard deviation could not be calculated due to single evaluable participant.", 'groupId': 'OG000'}, {'value': '100.0', 'spread': 'NA', 'comment': "Here, 'NA' signifies that standard deviation could not be calculated due to single evaluable participant.", 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "Here, 'NA' signifies that, per planned analysis, data was not summarized where number of participants analyzed was less than 3. Only individual participant data was collected and analyzed which is reported in the first 2 arms.", 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose at 0 hour: Days 8 and 15 of Cycle 1; Days 1 and 15 of Cycles 2, 3 and 4; Day 1 of Cycles 6 and 8 (each cycle was of 28 days)', 'description': 'Ctrough of amivantamab in GC and EC cohorts were reported. Ctrough was defined as pre-dose serum drug concentration. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]).', 'unitOfMeasure': 'Micrograms per milliliter (mcg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline measurement. Here 'N' (overall number of participants analyzed) = participants evaluable for this outcome measure and 'n' (number analyzed) = refers to participants evaluable at specified time points."}, {'type': 'SECONDARY', 'title': 'Phase 2a Esophageal Cancer Higher Dose Cohort: Serum Trough Concentrations (Ctrough) of Amivantamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)', 'description': 'Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight \\<80 kg or 2100 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight \\<80 kg or 1750 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}], 'classes': [{'title': 'Pre-dose Cycle 1 Day 15: Participant 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '333', 'spread': 'NA', 'comment': "Here, 'NA' signifies that standard deviation could not be calculated due to single evaluable participant.", 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose Cycle 1 Day 15: Participant 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '337', 'spread': 'NA', 'comment': "Here, 'NA' signifies that standard deviation could not be calculated due to single evaluable participant.", 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose Cycle 2 Day 1: Participant 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '657', 'spread': 'NA', 'comment': "Here, 'NA' signifies that standard deviation could not be calculated due to single evaluable participant.", 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose Cycle 2 Day 1: Participant 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '779', 'spread': 'NA', 'comment': "Here, 'NA' signifies that standard deviation could not be calculated due to single evaluable participant.", 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose Cycle 2 Day 15: Participant 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '590', 'spread': 'NA', 'comment': "Here, 'NA' signifies that standard deviation could not be calculated due to single evaluable participant.", 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose Cycle 2 Day 15: Participant 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '604', 'spread': 'NA', 'comment': "Here, 'NA' signifies that standard deviation could not be calculated due to single evaluable participant.", 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose Cycle 3 Day 1: Participant 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '433', 'spread': 'NA', 'comment': "Here, 'NA' signifies that standard deviation could not be calculated due to single evaluable participant.", 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose Cycle 3 Day 1: Participant 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '600', 'spread': 'NA', 'comment': "Here, 'NA' signifies that standard deviation could not be calculated due to single evaluable participant.", 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose Cycle 3 Day 15: Participant 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '460', 'spread': 'NA', 'comment': "Here, 'NA' signifies that standard deviation could not be calculated due to single evaluable participant.", 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose Cycle 6 Day 1: Participant 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '295', 'spread': 'NA', 'comment': "Here, 'NA' signifies that standard deviation could not be calculated due to single evaluable participant.", 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose Cycle 8 Day 1: Participant 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '314', 'spread': 'NA', 'comment': "Here, 'NA' signifies that standard deviation could not be calculated due to single evaluable participant.", 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose at 0 hour: Day 15 of Cycle 1; Days 1 and 15 of Cycles 2 and 3; Day 1 of Cycles 6 and 8 (each cycle was of 28 days)', 'description': 'Ctrough of amivantamab in phase 2a EC higher dose cohort was reported. Ctrough was defined as pre-dose serum drug concentration. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method.', 'unitOfMeasure': 'Micrograms per milliliter (mcg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline measurement. Here \'N\' (overall number of participants analyzed) = the participants evaluable for this outcome measure and \'n\' (number analyzed) = participants evaluable at specified time points. As planned participant wise data was collected and analyzed when "n" was less than (\\<) 3.'}, {'type': 'SECONDARY', 'title': 'Phase 2a Gastric Cancer Cohort: Terminal Elimination Half-Life (t1/2) for Amivantamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic gastric/gastroesophageal junction cancer (GC) exhibiting varying degrees of epidermal growth factor receptor (EGFR), tyrosine-protein kinase mesenchymal-epithelial transition (MET), or both as determined by immunohistochemistry (IHC) received amivantamab 1050 milligrams (mg) for body weight less than (\\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg/1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}], 'classes': [{'title': 'Participant 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '226.0', 'spread': 'NA', 'comment': "Here, 'NA' signifies that standard deviation could not be calculated due to single evaluable participant.", 'groupId': 'OG000'}]}]}, {'title': 'Participant 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '264.5', 'spread': 'NA', 'comment': "Here, 'NA' signifies that standard deviation could not be calculated due to single evaluable participant.", 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)', 'description': 'Terminal elimination half-life (t1/2) was the time measured for the serum concentration of a drug to decrease by half of its initial concentration. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline measurement. Here \'N\' (overall number of participants analyzed) = the participants evaluable for this outcome measure and \'n\' (number analyzed) = participants evaluable at specified row. As planned participant wise data was collected and analyzed when "n" was \\<3.'}, {'type': 'SECONDARY', 'title': 'Phase 2a Esophageal Cancer and Overall Combined Cohorts: Terminal Elimination Half-Life (t1/2) for Amivantamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG001', 'title': 'Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)', 'description': 'Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight \\<80 kg or 2100 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight \\<80 kg or 1750 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG002', 'title': 'Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic GC and EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '254.7', 'spread': '43.0', 'groupId': 'OG000'}, {'value': '252.6', 'spread': '38.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)', 'description': 'Terminal elimination half-life (t1/2) was the time measured for the serum concentration of a drug to decrease by half of its initial concentration. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for EC cohort and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for t1/2 was not collected and analyzed for Phase 2a EC higher dose cohort.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline measurement. Here 'N' (overall number of participants analyzed) refers to the participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Apparent Clearance at Steady State (CLss) of Amivantamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic gastric/gastroesophageal junction cancer (GC) exhibiting varying degrees of epidermal growth factor receptor (EGFR), tyrosine-protein kinase mesenchymal-epithelial transition (MET), or both as determined by immunohistochemistry (IHC) received amivantamab 1050 milligrams (mg) for body weight less than (\\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg/1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG001', 'title': 'Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG002', 'title': 'Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)', 'description': 'Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight \\<80 kg or 2100 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight \\<80 kg or 1750 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG003', 'title': 'Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic GC and EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00775', 'spread': '0.00122', 'groupId': 'OG000'}, {'value': '0.00695', 'spread': '0.00200', 'groupId': 'OG001'}, {'value': '0.00722', 'spread': '0.00176', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)', 'description': 'Clearance was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for CLss was not collected and analyzed for Phase 2a EC higher dose cohort.', 'unitOfMeasure': 'Liters/hour (L/h)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline measurement. Here 'N' (overall number of participants analyzed) refers to the participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution at Steady State (Vss) of Amivantamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic gastric/gastroesophageal junction cancer (GC) exhibiting varying degrees of epidermal growth factor receptor (EGFR), tyrosine-protein kinase mesenchymal-epithelial transition (MET), or both as determined by immunohistochemistry (IHC) received amivantamab 1050 milligrams (mg) for body weight less than (\\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg/1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG001', 'title': 'Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG002', 'title': 'Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)', 'description': 'Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight \\<80 kg or 2100 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight \\<80 kg or 1750 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG003', 'title': 'Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic GC and EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.59', 'spread': 'NA', 'comment': "Here, 'NA' signifies that standard deviation could not be calculated due to single evaluable participant.", 'groupId': 'OG000'}, {'value': '2.61', 'spread': '1.04', 'groupId': 'OG001'}, {'value': '2.75', 'spread': '1.02', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)', 'description': 'Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for Vss was not collected and analyzed for Phase 2a EC higher dose cohort.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline measurement. Here 'N' (overall number of participants analyzed) refers to the participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio (AR) of AUCtau for Amivantamab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic gastric/gastroesophageal junction cancer (GC) exhibiting varying degrees of epidermal growth factor receptor (EGFR), tyrosine-protein kinase mesenchymal-epithelial transition (MET), or both as determined by immunohistochemistry (IHC) received amivantamab 1050 milligrams (mg) for body weight less than (\\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg/1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG001', 'title': 'Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG002', 'title': 'Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)', 'description': 'Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight \\<80 kg or 2100 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight \\<80 kg or 1750 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG003', 'title': 'Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic GC and EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.32', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '5.12', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '4.85', 'spread': '0.74', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0, 24, 26, 48, 72, 96 and 168 hours post-dose on Day 1 of Cycle 1; pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)', 'description': 'Accumulation ratio for AUC was calculated as AUC (0-336h) for Cycle 2 Day 1 divided by AUC (0-168h) for Cycle 1 Day 1. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for AR of AUCtau was not collected and analyzed for Phase 2a EC higher dose cohort.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline measurement. Here 'N' (overall number of participants analyzed) refers to the participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Amivantamab Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic gastric/gastroesophageal junction cancer (GC) exhibiting varying degrees of epidermal growth factor receptor (EGFR), tyrosine-protein kinase mesenchymal-epithelial transition (MET), or both as determined by immunohistochemistry (IHC) received amivantamab 1050 milligrams (mg) for body weight less than (\\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg/1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG001', 'title': 'Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'OG002', 'title': 'Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)', 'description': 'Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight \\<80 kg or 2100 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight \\<80 kg or 1750 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of the treatment (Day 1) up to 30 days after the last dose of study drug (up to 9 months)', 'description': 'Number of participants with anti-amivantamab antibodies were reported. Serum samples were assessed for anti-drug antibodies.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The immunogenicity analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline measurement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic gastric/gastroesophageal junction cancer (GC) exhibiting varying degrees of epidermal growth factor receptor (EGFR), tyrosine-protein kinase mesenchymal-epithelial transition (MET), or both as determined by immunohistochemistry (IHC) received amivantamab 1050 milligrams (mg) for body weight less than (\\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg/1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'FG001', 'title': 'Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'FG002', 'title': 'Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)', 'description': 'Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight \\<80 kg or 2100 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight \\<80 kg or 1750 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The study was planned to be conducted in 2 cohorts: Phase 2a cohorts (including Phase 2a extension cohort) and Phase 2b expansion cohort in participants with previously treated advanced or metastatic gastric or esophageal cancer. However, due to study termination, no participants were enrolled in Phase 2a extension cohorts and Phase 2b cohorts. Hence the results were only presented for Phase 2a cohorts.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic gastric/gastroesophageal junction cancer (GC) exhibiting varying degrees of epidermal growth factor receptor (EGFR), tyrosine-protein kinase mesenchymal-epithelial transition (MET), or both as determined by immunohistochemistry (IHC) received amivantamab 1050 milligrams (mg) for body weight less than (\\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg/1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'BG001', 'title': 'Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)', 'description': 'Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \\<80 kg or 1400 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \\<80 kg or 1050 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'BG002', 'title': 'Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)', 'description': 'Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight \\<80 kg or 2100 mg for body weight \\>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight \\<80 kg or 1750 mg for body weight \\>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose.'}, {'id': 'BG003', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'spread': '11.97', 'groupId': 'BG000'}, {'value': '62.7', 'spread': '10.35', 'groupId': 'BG001'}, {'value': '60', 'spread': '9', 'groupId': 'BG002'}, {'value': '63.2', 'spread': '10.97', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}]}], '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'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'JAPAN', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-16', 'size': 2115727, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-03T02:56', 'hasProtocol': True}, {'date': '2023-08-11', 'size': 2068358, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-03T02:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'whyStopped': 'Due to reconsideration of development strategy', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-22', 'studyFirstSubmitDate': '2021-06-23', 'resultsFirstSubmitDate': '2024-07-03', 'studyFirstSubmitQcDate': '2021-06-23', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-22', 'studyFirstPostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1', 'timeFrame': 'From start of the treatment (Day 1) up to 30 days after the last dose of study drug (up to 9 months)', 'description': 'ORR was defined as the percentage of participants who achieved a confirmed complete response (CR) or partial response (PR) as determined by investigator per RECIST version 1.1. As per RECIST version 1.1, CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (\\<)10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-progressive disease (PD). For non-target lesions, PD: unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression.'}], 'secondaryOutcomes': [{'measure': 'Disease Control Rate (DCR) Per RECIST Version 1.1', 'timeFrame': 'From start of the treatment (Day 1) up to 30 days after the last dose of study drug (up to 9 months)', 'description': 'DCR was defined as the percentage of participants achieving CR or PR or stable disease (SD) for at least 6 weeks as defined by RECIST version 1.1. As per RECIST version 1.1 CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \\<10 mm. PR was defined as \\>=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. For non-target lesions, PD: unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, and no appearance of new lesion(s).'}, {'measure': 'Duration of Response (DOR) as Per RECIST Version 1.1', 'timeFrame': 'From the date of first documented response up to date of first documented PD or death (up to 9 months)', 'description': 'DOR was defined as time between date of first documented response (CR/PR) and date of first documented progression or death, whichever occurred first. CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes short axis measures \\<10 mm. PR was defined as \\>=30% decrease in sum of measures (tumor lesions-longest diameter and nodes-short axis) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. For non-target lesions, PD: unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. There was no participant who had event (CR/PR) in Phase 2a EC higher dose cohort, hence data could not be collected and analyzed for this cohort.'}, {'measure': 'Time to Response (TTR) as Per RECIST Version 1.1', 'timeFrame': 'From first dose of study treatment until first documentation of CR or PR (up to 9 months)', 'description': 'TTR was defined as time from date of first amivantamab administration to date of achieving objective response (CR/PR) as assessed by investigator per RECIST v1.1 among participants who achieved objective response. Per RECIST v1.1, CR: disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \\<10 mm. PR: \\>=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. For non-target lesions, PD: unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. There was no participant who had event (CR/PR) in Phase 2a EC higher dose cohort, hence data could not be collected and analyzed for this cohort.'}, {'measure': 'Progression Free Survival (PFS) as Per RECIST Version 1.1', 'timeFrame': 'From day of first dose (Day 1) until PD or death (up to 9 months)', 'description': 'PFS was defined as the time from the date of first dose of study drug until the date of objective disease progression or death (by any cause in the absence of progression), whichever comes first, based on investigator assessment using RECIST Version 1.1.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0', 'timeFrame': 'From start of the treatment (Day 1) up to 30 days after last dose or start of new anticancer therapy, whichever occurred first (up to 9 months)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs was defined as AEs occurring at or after first dose of study drug up to 30 days after last dose or until the start of new anticancer therapy, whichever occurred first. TEAEs were graded according to NCI-CTCAE v5.0. Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe or medically significant but not immediately life-threatening; Grade 4- Life-threatening consequences; Grade 5- Death related to AE. All TEAEs including serious and non-serious events are reported in this outcome measure.'}, {'measure': 'Maximum Observed Serum Concentration (Cmax) for Amivantamab', 'timeFrame': 'Pre-dose, 0, 24, 26, 48, 72, 96 and 168 hours post-dose on Day 1 of Cycle 1; pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)', 'description': 'Cmax was defined as the maximum observed serum concentration of amivantamab. The concentrations of amivantamab were measured using a validated, specific, and sensitive enzyme-linked immunosorbent assay (ELISA) method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for Cmax was not collected and analyzed for Phase 2a EC higher dose cohort.'}, {'measure': 'Time to Reach Maximum Observed Serum Concentration (Tmax) for Amivantamab', 'timeFrame': 'Pre-dose, 0, 24, 26, 48, 72, 96 and 168 hours post-dose on Day 1 of Cycle 1; pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)', 'description': 'Tmax was defined as the time to reach maximum observed serum concentration of amivantamab. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for Tmax was not collected and analyzed for Phase 2a EC higher dose cohort.'}, {'measure': 'Area Under the Curve From Time (0) to Time (168h) (AUC [0-168h]) for Amivantamab', 'timeFrame': 'Pre-dose, 0, 24, 26, 48, 72, 96 and 168 hours post-dose on Day 1 of Cycle 1 (each cycle was of 28 days)', 'description': 'AUC (0-168h) was defined as area under the serum concentration time-curve from time zero to the time point 168 hours. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for AUC (0-168h) was not collected and analyzed for Phase 2a EC higher dose cohort.'}, {'measure': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Amivantamab', 'timeFrame': 'Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)', 'description': 'Area under the serum concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 336 hours was reported. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for AUCtau was not collected and analyzed for Phase 2a EC higher dose cohort.'}, {'measure': 'Phase 2a Gastric Cancer and Esophageal Cancer Cohorts: Serum Trough Concentrations (Ctrough) of Amivantamab', 'timeFrame': 'Pre-dose at 0 hour: Days 8 and 15 of Cycle 1; Days 1 and 15 of Cycles 2, 3 and 4; Day 1 of Cycles 6 and 8 (each cycle was of 28 days)', 'description': 'Ctrough of amivantamab in GC and EC cohorts were reported. Ctrough was defined as pre-dose serum drug concentration. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]).'}, {'measure': 'Phase 2a Esophageal Cancer Higher Dose Cohort: Serum Trough Concentrations (Ctrough) of Amivantamab', 'timeFrame': 'Pre-dose at 0 hour: Day 15 of Cycle 1; Days 1 and 15 of Cycles 2 and 3; Day 1 of Cycles 6 and 8 (each cycle was of 28 days)', 'description': 'Ctrough of amivantamab in phase 2a EC higher dose cohort was reported. Ctrough was defined as pre-dose serum drug concentration. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method.'}, {'measure': 'Phase 2a Gastric Cancer Cohort: Terminal Elimination Half-Life (t1/2) for Amivantamab', 'timeFrame': 'Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)', 'description': 'Terminal elimination half-life (t1/2) was the time measured for the serum concentration of a drug to decrease by half of its initial concentration. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method.'}, {'measure': 'Phase 2a Esophageal Cancer and Overall Combined Cohorts: Terminal Elimination Half-Life (t1/2) for Amivantamab', 'timeFrame': 'Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)', 'description': 'Terminal elimination half-life (t1/2) was the time measured for the serum concentration of a drug to decrease by half of its initial concentration. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for EC cohort and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for t1/2 was not collected and analyzed for Phase 2a EC higher dose cohort.'}, {'measure': 'Apparent Clearance at Steady State (CLss) of Amivantamab', 'timeFrame': 'Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)', 'description': 'Clearance was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for CLss was not collected and analyzed for Phase 2a EC higher dose cohort.'}, {'measure': 'Apparent Volume of Distribution at Steady State (Vss) of Amivantamab', 'timeFrame': 'Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)', 'description': 'Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for Vss was not collected and analyzed for Phase 2a EC higher dose cohort.'}, {'measure': 'Accumulation Ratio (AR) of AUCtau for Amivantamab', 'timeFrame': 'Pre-dose, 0, 24, 26, 48, 72, 96 and 168 hours post-dose on Day 1 of Cycle 1; pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)', 'description': 'Accumulation ratio for AUC was calculated as AUC (0-336h) for Cycle 2 Day 1 divided by AUC (0-168h) for Cycle 1 Day 1. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab \\[1050/1400 mg\\]). As planned, data for AR of AUCtau was not collected and analyzed for Phase 2a EC higher dose cohort.'}, {'measure': 'Number of Participants With Anti-Amivantamab Antibodies', 'timeFrame': 'From start of the treatment (Day 1) up to 30 days after the last dose of study drug (up to 9 months)', 'description': 'Number of participants with anti-amivantamab antibodies were reported. Serum samples were assessed for anti-drug antibodies.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stomach Neoplasms', 'Esophageal Neoplasms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the activity of amivantamab in gastric cancer (GC) and esophageal cancer (EC) participants (Phase 2a), and to characterize the preliminary antitumor activity of amivantamab in selected GC and EC population (Phase 2b).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant must have histologically or cytologically confirmed gastric (including gastroesophageal junction \\[GEJ\\]) or esophageal cancer (EC) that is locally advanced, unresectable, or metastatic, and not eligible for curative treatment\n* Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. If only 1 measurable lesion exists, it may be used for the screening biopsy if the baseline tumor assessment scans are performed greater than or equal to (\\>=) 7 days after the biopsy\n* Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n\nGastric or GEJ Cancer Only - Must be refractory or ineligible to at least 2 prior lines of standard of care systemic therapy. Prior therapies must include fluoropyrimidine- and platinum-based chemotherapy. Participants with known human epidermal growth factor receptor (HER) 2 expression must have had HER2 targeting therapy as part of the prior therapy\n\nEsophageal Cancer Only\n\n\\- Must be refractory or intolerant to at least 1 prior line of systemic therapy. Prior therapies must include fluoropyrimidine-, and platinum-based chemotherapy (including chemoradiation therapy given as stage intravenous \\[IV\\] setting)\n\nExclusion Criteria:\n\n* Participant has an uncontrolled illness, including but not limited to the following: diabetes; ongoing or active bacterial infection (includes infection requiring treatment with antimicrobial therapy \\[participants will be required to complete antibiotics 1 week before enrollment\\]), symptomatic viral infection, or any other clinically significant infection; active bleeding diathesis and psychiatric illness/social situation that would limit compliance with study requirements\n* Participant has received prior epidermal growth factor receptor (EGFR) or tyrosine-protein kinase mesenchymal-epithelial transition (cMet)-directed therapies\n* Participant has had prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or 4 half-lives whichever is longer or had radiation therapy within 4 weeks before the first administration of study treatment. For agents with long half-lives, the maximum required time since last dose is 28 days. Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less, (except for alopecia or post-radiation skin changes \\[any grade\\], Grade less than or equal to \\[\\<=\\] 2 peripheral neuropathy, and Grade \\<=2 hypothyroidism stable on hormone replacement)\n* Participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to the first administration of study treatment is eligible), history of leptomeningeal disease or spinal cord compression that has not been treated definitively with surgery or radiation. If brain metastases are diagnosed on screening imaging, the participant may be rescreened for eligibility after definitive treatment\n* Participant has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. Esophageal cancer participants with history of completely resolved radiation pneumonitis (defined as radiographically stable for 3 months prior to enrollment without need of any treatment) may be enrolled'}, 'identificationModule': {'nctId': 'NCT04945733', 'briefTitle': 'A Study of Amivantamab in Participants With Previously Treated Advanced or Metastatic Gastric or Esophageal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Pharmaceutical K.K.'}, 'officialTitle': 'A Phase 2, Open-label Study of Amivantamab in Subjects With Previously Treated Advanced or Metastatic Gastric or Esophageal Cancer', 'orgStudyIdInfo': {'id': 'CR109026'}, 'secondaryIdInfos': [{'id': '61186372GIC2001', 'type': 'OTHER', 'domain': 'Janssen Pharmaceutical K.K., Japan'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amivantamab: Gastric Cancer (GC) Cohorts', 'description': 'Participants in Phase 2a GC cohorts will receive intravenous (IV) infusion of weight-based dose of amivantamab in 28-day cycles. Participants with body weight less than (\\<) 80 kilograms (kg) will receive IV infusion of amivantamab 1,050 milligrams (mg) and participants with body weight greater than or equal to (\\>=) 80 kg will receive IV infusion of amivantamab 1,400 mg once weekly in Cycle 1 and then every 2 weeks in subsequent cycles (on Days 1 and 15 of each cycle), followed by additional dosing based on body weight if recommended by clinical trial management team (CTMT) (amivantamab 1750 mg for body weight \\<80 kg and 2100 mg for body weight \\>=80 kg as IV infusion) every 2 weeks on Days 1 and 15 of 28 day cycle. Phase 2b GC expansion cohorts will be initiated if activity is observed within Phase 2a cohorts.', 'interventionNames': ['Drug: Amivantamab']}, {'type': 'EXPERIMENTAL', 'label': 'Amivantamab: Esophageal Cancer (EC) Cohorts', 'description': 'Participants in Phase 2a EC cohorts will receive IV infusion of weight-based dose of amivantamab in 28-day cycles. Participants with body weight \\<80 kg will receive IV infusion of amivantamab 1,050 mg and participants with body weight \\>=80 kg will receive IV infusion of amivantamab 1,400 mg once weekly in Cycle 1 and then every 2 weeks in subsequent cycles (on Days 1 and 15 of each cycle) followed by additional dosing based on body weight if recommended by CTMT (amivantamab 1750 mg for body weight \\<80 kg and 2100 mg for body weight \\>=80 kg as IV infusion) every 2 weeks on Days 1 and 15 of 28 day cycle. Phase 2b EC expansion cohorts will be initiated if activity is observed within Phase 2a cohorts.', 'interventionNames': ['Drug: Amivantamab']}], 'interventions': [{'name': 'Amivantamab', 'type': 'DRUG', 'otherNames': ['JNJ-61186372'], 'description': 'Amivantamab will be administered intravenously.', 'armGroupLabels': ['Amivantamab: Esophageal Cancer (EC) Cohorts', 'Amivantamab: Gastric Cancer (GC) Cohorts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '104 0045', 'city': 'Chūōku', 'country': 'Japan', 'facility': 'National Cancer Center Hospital', 'geoPoint': {'lat': 33.63867, 'lon': 130.67068}}, {'zip': '277 8577', 'city': 'Kashiwa', 'country': 'Japan', 'facility': 'National Cancer Center Hospital East', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}, {'zip': '362-0806', 'city': 'Kitaadachi-gun', 'country': 'Japan', 'facility': 'Saitama Cancer center'}, {'zip': '951-8566', 'city': 'Niigata', 'country': 'Japan', 'facility': 'Niigata Cancer Center Hospital', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'zip': '060-8648', 'city': 'Sapporo', 'country': 'Japan', 'facility': 'Hokkaido University Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '980 8574', 'city': 'Sendai', 'country': 'Japan', 'facility': 'Tohoku University Hospital', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '565-0871', 'city': 'Suita-shi', 'country': 'Japan', 'facility': 'Osaka University Hospital'}, {'zip': '113 8677', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '135 8550', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'The Cancer Institute Hospital of JFCR', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '232 0024', 'city': 'Yokohama', 'country': 'Japan', 'facility': 'Yokohama City University Medical Center', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}], 'overallOfficials': [{'name': 'Janssen Pharmaceutical K.K., Japan Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Pharmaceutical K.K.'}]}, 'ipdSharingStatementModule': {'url': 'https://www.janssen.com/clinical-trials/transparency', 'ipdSharing': 'YES', 'description': 'The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \\& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Pharmaceutical K.K.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}