Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-31 @ 1:23 PM
Study NCT ID:
NCT04740034
Status:
TERMINATED
Last Update Posted:
2025-06-17
First Post:
2021-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@amgen.com', 'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.', 'description': 'Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: Dose A', 'description': 'Participants with progressive mCRPC received Dose A of AMG 340 administered as an IV infusion Q3W.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 2: Dose B', 'description': 'Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 3: Dose C', 'description': 'Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Cohort 4: Dose D', 'description': 'Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 3, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Cohort 5: Dose E', 'description': 'Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 4, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 4, 'seriousNumAffected': 4}, {'id': 'EG006', 'title': 'Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG007', 'title': 'Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 2, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 4, 'seriousNumAffected': 4}, {'id': 'EG010', 'title': 'Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Ear congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 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'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Dose A', 'description': 'Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).'}, {'id': 'OG001', 'title': 'Cohort 2: Dose B', 'description': 'Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG002', 'title': 'Cohort 3: Dose C', 'description': 'Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG003', 'title': 'Cohort 4: Dose D', 'description': 'Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG004', 'title': 'Cohort 5: Dose E', 'description': 'Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG005', 'title': 'Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG006', 'title': 'Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG007', 'title': 'Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG008', 'title': 'Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG009', 'title': 'Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG010', 'title': 'Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}], 'classes': [{'title': 'All TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}]}, {'title': 'All SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}, {'title': 'All TRAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months', 'description': 'An adverse event (AE) was any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. A treatment-related AE (TRAE) was defined as any TEAE flagged as possibly caused by AMG 340. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. Serious TEAEs (SAEs) were any untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused significant disability, resulted in congenital anomalies, or were considered other medically important events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS: All participants who received at least 1 dose of AMG 340.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Dose A', 'description': 'Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).'}, {'id': 'OG001', 'title': 'Cohort 2: Dose B', 'description': 'Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG002', 'title': 'Cohort 3: Dose C', 'description': 'Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG003', 'title': 'Cohort 4: Dose D', 'description': 'Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG004', 'title': 'Cohort 5: Dose E', 'description': 'Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG005', 'title': 'Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG006', 'title': 'Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 high PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG007', 'title': 'Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG008', 'title': 'Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG009', 'title': 'Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG010', 'title': 'Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately Day 21', 'description': "A DLT was defined as a TEAE that was not unequivocally due to the participant's underlying malignancy or other extraneous cause, and appeared within 21 days from the first dose of AMG 340. AEs considered DLTs were:\n\n* Transient (≤72 hours) grade 3 or 4 electrolyte abnormalities, hyperglycemia, nausea/vomiting/diarrhea responsive to treatment.\n* Alopecia, vitiligo, and grade 3 fatigue lasting \\<10 days.\n* Grade 3 fever lasting ≤24 hours (outside CRS context).\n* Grade 3 lab abnormalities resolving within 72 hours (or within 7 days for certain enzymes like ALT, GGT, ALP, and lipase).\n* Grade 3 CRS or TLS unresolved to ≤ grade 1 within 72 hours or any grade 4 CRS/TLS.\n* Prolonged grade 4 neutropenia (\\>5 days) or febrile neutropenia.\n* Grade 3 thrombocytopenia with bleeding or any grade 4 thrombocytopenia.\n* Grade 4 anemia.\n* Grade 5 adverse events.\n* Lymphopenia is not considered a DLT.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'DLT evaluable analysis set: All participants who were evaluable for DLTs. A participants was considered DLT evaluable if the participant completed at least the first full treatment cycle or experienced a DLT during the first treatment cycle.'}, {'type': 'PRIMARY', 'title': 'Median Concentration of AMG 340', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Dose A', 'description': 'Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).'}, {'id': 'OG001', 'title': 'Cohort 2: Dose B', 'description': 'Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG002', 'title': 'Cohort 3: Dose C', 'description': 'Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG003', 'title': 'Cohort 4: Dose D', 'description': 'Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG004', 'title': 'Cohort 5: Dose E', 'description': 'Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG005', 'title': 'Cohort 6: AMG 340 PmD (Low) and (High), and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (low) and (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG006', 'title': 'Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG007', 'title': 'Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG008', 'title': 'Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG009', 'title': 'Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.352', 'groupId': 'OG000', 'lowerLimit': '0.352', 'upperLimit': '0.352'}, {'value': '0.818', 'groupId': 'OG001', 'lowerLimit': '0.818', 'upperLimit': '0.818'}, {'value': '2.445', 'groupId': 'OG002', 'lowerLimit': '0.233', 'upperLimit': '4.71'}, {'value': '6.78', 'groupId': 'OG003', 'lowerLimit': '0.661', 'upperLimit': '16.2'}, {'value': '17.8', 'groupId': 'OG004', 'lowerLimit': '0.116', 'upperLimit': '54.5'}, {'value': '19.25', 'groupId': 'OG005', 'lowerLimit': '0', 'upperLimit': '52.3'}, {'value': '54.4', 'groupId': 'OG006', 'lowerLimit': '3.61', 'upperLimit': '129'}, {'value': '68.0', 'groupId': 'OG007', 'lowerLimit': '17.1', 'upperLimit': '149'}, {'value': '75.2', 'groupId': 'OG008', 'lowerLimit': '2.64', 'upperLimit': '201'}, {'value': '201', 'groupId': 'OG009', 'lowerLimit': '79.1', 'upperLimit': '397'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cohorts 1-5: Days 1 (pre-dose to 6 hours post-dose), 2, 3, 8, and 10; Cohorts 6-10: Days 1 (pre-dose to 6 hours post-dose), 2, 3, 5 (pre-dose to 6 hours post-dose), 6, 7, 8 (pre-dose to 6 hours post-dose), 9, 10', 'description': 'Blood samples for pharmacokinetics (PK) analysis were collected at specific time points. PK parameters were estimated using standard non-compartmental approaches.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set: Included all participants who received at least 1 dose of AMG 340 and had at least 1 PK sample drawn post dose. Summary statistics are presented per dose level as pre-specified in SAP Section 9.7.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved an Objective Response (OR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Dose A', 'description': 'Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).'}, {'id': 'OG001', 'title': 'Cohort 2: Dose B', 'description': 'Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG002', 'title': 'Cohort 3: Dose C', 'description': 'Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG003', 'title': 'Cohort 4: Dose D', 'description': 'Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG004', 'title': 'Cohort 5: Dose E', 'description': 'Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG005', 'title': 'Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG006', 'title': 'Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG007', 'title': 'Cohort 7a: AMG 340 PmD A and Then AMG 340 Dose F', 'description': 'Participants with progressive mCRPC received AMG 340 PmD A on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG008', 'title': 'Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG009', 'title': 'Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG010', 'title': 'Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '70.76'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '84.19'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '60.24'}, {'value': '0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '60.24'}, {'value': '0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '84.19'}, {'value': '0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '70.76'}, {'value': '0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '84.19'}, {'value': '0', 'groupId': 'OG009', 'lowerLimit': '0.0', 'upperLimit': '52.18'}, {'value': '0', 'groupId': 'OG010', 'lowerLimit': '0.0', 'upperLimit': '84.19'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 24 months', 'description': 'OR was defined as a partial response (PR) or complete response (CR) per RECIST 1.1, confirmed by a repeat assessment at least 4 weeks later. Participants who did not experience a confirmed PR/CR or did not have any follow-up tumor assessments were regarded as non-responders.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'RECIST 1.1 Evaluable Analysis Set: All participants who have received at least 1 dose of AMG 340, had measurable disease per RECIST 1.1 at baseline, and had the opportunity to be followed for at least 6 weeks from start of AMG 340 treatment.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Dose A', 'description': 'Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).'}, {'id': 'OG001', 'title': 'Cohort 2: Dose B', 'description': 'Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG002', 'title': 'Cohort 3: Dose C', 'description': 'Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG003', 'title': 'Cohort 4: Dose D', 'description': 'Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG004', 'title': 'Cohort 5: Dose E', 'description': 'Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG005', 'title': 'Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG006', 'title': 'Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG007', 'title': 'Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG008', 'title': 'Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG009', 'title': 'Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG010', 'title': 'Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '9.2', 'upperLimit': '9.2'}, {'value': '13.4', 'groupId': 'OG001', 'lowerLimit': '13.4', 'upperLimit': '13.4'}, {'value': '10.22', 'groupId': 'OG002', 'lowerLimit': '4.8', 'upperLimit': '12.2'}, {'value': '11.56', 'groupId': 'OG003', 'lowerLimit': '3.4', 'upperLimit': '20.3'}, {'value': '5.59', 'groupId': 'OG004', 'lowerLimit': '1.6', 'upperLimit': '19.2'}, {'value': '8.15', 'groupId': 'OG005', 'lowerLimit': '3.1', 'upperLimit': '19.3'}, {'value': '5.45', 'groupId': 'OG006', 'lowerLimit': '4.2', 'upperLimit': '25.7'}, {'value': 'NA', 'comment': 'Median could not be calculated as there was an insufficient number of participants with events.', 'groupId': 'OG007', 'lowerLimit': '3.0', 'upperLimit': '28.2'}, {'value': '6.97', 'groupId': 'OG008', 'lowerLimit': '1.5', 'upperLimit': '27.1'}, {'value': '7.56', 'groupId': 'OG009', 'lowerLimit': '0.5', 'upperLimit': '15.4'}, {'value': 'NA', 'comment': 'Median could not be calculated as there was an insufficient number of participants with events.', 'groupId': 'OG010', 'lowerLimit': '8.5', 'upperLimit': '10.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 24 months', 'description': 'OS was defined as the time from the date of study Day 1 until death due to any cause.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS: All participants who received at least 1 dose of AMG 340.'}, {'type': 'SECONDARY', 'title': 'Prostate Specific Antigen (PSA) Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Dose A', 'description': 'Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).'}, {'id': 'OG001', 'title': 'Cohort 2: Dose B', 'description': 'Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG002', 'title': 'Cohort 3: Dose C', 'description': 'Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG003', 'title': 'Cohort 4: Dose D', 'description': 'Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG004', 'title': 'Cohort 5: Dose E', 'description': 'Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG005', 'title': 'Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG006', 'title': 'Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG007', 'title': 'Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG008', 'title': 'Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG009', 'title': 'Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG010', 'title': 'Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '1.4'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '2.1'}, {'value': '4.83', 'groupId': 'OG002', 'lowerLimit': '3.4', 'upperLimit': '6.9'}, {'value': '3.20', 'groupId': 'OG003', 'lowerLimit': '2.1', 'upperLimit': '6.2'}, {'value': '2.89', 'groupId': 'OG004', 'lowerLimit': '1.5', 'upperLimit': '8.3'}, {'value': '3.12', 'groupId': 'OG005', 'lowerLimit': '1.9', 'upperLimit': '8.1'}, {'value': '2.8', 'groupId': 'OG006', 'lowerLimit': '2.8', 'upperLimit': '5.5'}, {'value': '3.48', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '3.8'}, {'value': '6.97', 'groupId': 'OG008', 'lowerLimit': '1.5', 'upperLimit': '27.1'}, {'value': '4.86', 'groupId': 'OG009', 'lowerLimit': '0.0', 'upperLimit': '9.4'}, {'value': 'NA', 'comment': 'Median could not be calculated as there was an insufficient number of participants with events.', 'groupId': 'OG010', 'lowerLimit': '1.4', 'upperLimit': '1.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 24 months', 'description': 'PSA PFS was defined as the interval from study day 1 to the earlier of a PSA progression or death from any cause; otherwise, PSA PFS was censored on the date of the last PSA measurement. If a participant had no baseline or post-baseline PSA measurement and a vital status of alive or unknown, PSA PFS was censored at study day 1.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS: All participants who received at least 1 dose of AMG 340.'}, {'type': 'SECONDARY', 'title': 'Radiographic PFS (rPFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Dose A', 'description': 'Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).'}, {'id': 'OG001', 'title': 'Cohort 2: Dose B', 'description': 'Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG002', 'title': 'Cohort 3: Dose C', 'description': 'Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG003', 'title': 'Cohort 4: Dose D', 'description': 'Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG004', 'title': 'Cohort 5: Dose E', 'description': 'Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG005', 'title': 'Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG006', 'title': 'Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG007', 'title': 'Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG008', 'title': 'Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG009', 'title': 'Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG010', 'title': 'Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median could not be calculated as there was an insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '7.8'}, {'value': '3.48', 'groupId': 'OG001', 'lowerLimit': '3.48', 'upperLimit': '3.48'}, {'value': '5.32', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '7.2'}, {'value': '3.38', 'groupId': 'OG003', 'lowerLimit': '1.2', 'upperLimit': '3.4'}, {'value': '1.56', 'groupId': 'OG004', 'lowerLimit': '1.4', 'upperLimit': '6.2'}, {'value': '2.25', 'groupId': 'OG005', 'lowerLimit': '0.9', 'upperLimit': '9.4'}, {'value': '4.27', 'groupId': 'OG006', 'lowerLimit': '1.2', 'upperLimit': '5.5'}, {'value': '3.84', 'groupId': 'OG007', 'lowerLimit': '1.4', 'upperLimit': '7.5'}, {'value': '1.31', 'groupId': 'OG008', 'lowerLimit': '1.2', 'upperLimit': '11.7'}, {'value': '2.35', 'groupId': 'OG009', 'lowerLimit': '0.00', 'upperLimit': '13.6'}, {'value': 'NA', 'comment': 'Median could not be calculated as there was an insufficient number of participants with events.', 'groupId': 'OG010', 'lowerLimit': '1.9', 'upperLimit': '3.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 24 months', 'description': 'rPFS was defined as the interval from study day 1 to radiographic progression or death from any cause, whichever occurred first, in the absence of subsequent anti-cancer therapy; otherwise, rPFS was censored at the last evaluable tumor assessment date prior to subsequent anti-cancer therapy.\n\nIf a participant had no post-baseline radiographic tumor assessment and a vital status of alive or unknown, rPFS was censored at study day 1.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS: All participants who received at least 1 dose of AMG 340.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With rPFS at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Dose A', 'description': 'Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).'}, {'id': 'OG001', 'title': 'Cohort 2: Dose B', 'description': 'Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG002', 'title': 'Cohort 3: Dose C', 'description': 'Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG003', 'title': 'Cohort 4: Dose D', 'description': 'Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG004', 'title': 'Cohort 5: Dose E', 'description': 'Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG005', 'title': 'Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG006', 'title': 'Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG007', 'title': 'Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG008', 'title': 'Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG009', 'title': 'Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG010', 'title': 'Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'comment': '95% Confidence interval (CI) not estimable due to the low number of participants in the analysis population.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.0', 'comment': '95% CI not estimable due to the low number of participants in the analysis population.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '33.3', 'groupId': 'OG002', 'lowerLimit': '0.9', 'upperLimit': '77.4'}, {'value': '0.0', 'comment': '95% CI could not be calculated as there was an insufficient number of participants with events.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '4.6', 'upperLimit': '67.6'}, {'value': '16.7', 'groupId': 'OG005', 'lowerLimit': '0.8', 'upperLimit': '51.7'}, {'value': '0.0', 'comment': '95% CI not estimable due to the low number of participants in the analysis population.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '33.3', 'groupId': 'OG007', 'lowerLimit': '0.9', 'upperLimit': '77.4'}, {'value': '33.3', 'groupId': 'OG008', 'lowerLimit': '0.9', 'upperLimit': '77.4'}, {'value': '16.7', 'groupId': 'OG009', 'lowerLimit': '0.8', 'upperLimit': '51.7'}, {'value': 'NA', 'comment': 'Median and 95% CI not estimable due to the low number of participants in the analysis population.', 'groupId': 'OG010', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'rPFS was defined as the interval from study day 1 to radiographic progression or death from any cause, whichever occurred first, in the absence of subsequent anti-cancer therapy; otherwise, rPFS was censored at the last evaluable tumor assessment date prior to subsequent anti-cancer therapy.\n\nIf a participant had no post-baseline radiographic tumor assessment and a vital status of alive or unknown, rPFS was censored at study day 1.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS: All participants who received at least 1 dose of AMG 340.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a 30% Reduction From Baseline in PSA (PSA30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Dose A', 'description': 'Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).'}, {'id': 'OG001', 'title': 'Cohort 2: Dose B', 'description': 'Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG002', 'title': 'Cohort 3: Dose C', 'description': 'Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG003', 'title': 'Cohort 4: Dose D', 'description': 'Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG004', 'title': 'Cohort 5: Dose E', 'description': 'Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG005', 'title': 'Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG006', 'title': 'Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG007', 'title': 'Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG008', 'title': 'Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG009', 'title': 'Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG010', 'title': 'Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '97.50'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '100.00'}, {'value': '33.3', 'groupId': 'OG002', 'lowerLimit': '0.84', 'upperLimit': '90.57'}, {'value': '20.0', 'groupId': 'OG003', 'lowerLimit': '0.51', 'upperLimit': '71.64'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '45.93'}, {'value': '16.7', 'groupId': 'OG005', 'lowerLimit': '0.42', 'upperLimit': '64.12'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.00', 'upperLimit': '70.76'}, {'value': '20.0', 'groupId': 'OG007', 'lowerLimit': '0.51', 'upperLimit': '71.64'}, {'value': '33.3', 'groupId': 'OG008', 'lowerLimit': '0.84', 'upperLimit': '90.57'}, {'value': '0.0', 'groupId': 'OG009', 'lowerLimit': '0.00', 'upperLimit': '40.96'}, {'value': '0.0', 'groupId': 'OG010', 'lowerLimit': '0.00', 'upperLimit': '84.19'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 24 months', 'description': 'PSA 30 was defined as a ≥ 30% reduction from the baseline PSA. This PSA response had to be confirmed by a second consecutive value obtained at least three weeks later.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PSA response evaluable analysis set was defined as all participants who received at least one dose of AMG 340, had a measurable (i.e., \\> 0) PSA at baseline, and had the opportunity to be followed for at least nine weeks from the start of AMG 340 treatment.\n\nParticipants who stopped disease assessments prior to nine weeks were included in this analysis set if the data snapshot date was at least nine weeks after their first study dose date.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a 50% Reduction From Baseline in PSA (PSA50)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Dose A', 'description': 'Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).'}, {'id': 'OG001', 'title': 'Cohort 2: Dose B', 'description': 'Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG002', 'title': 'Cohort 3: Dose C', 'description': 'Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG003', 'title': 'Cohort 4: Dose D', 'description': 'Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG004', 'title': 'Cohort 5: Dose E', 'description': 'Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG005', 'title': 'Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG006', 'title': 'Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG007', 'title': 'Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG008', 'title': 'Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG009', 'title': 'Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG010', 'title': 'Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '97.50'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '100.0'}, {'value': '33.3', 'groupId': 'OG002', 'lowerLimit': '0.84', 'upperLimit': '90.57'}, {'value': '20.0', 'groupId': 'OG003', 'lowerLimit': '0.51', 'upperLimit': '71.64'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '45.93'}, {'value': '16.7', 'groupId': 'OG005', 'lowerLimit': '0.42', 'upperLimit': '64.12'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.00', 'upperLimit': '70.76'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.00', 'upperLimit': '52.18'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.00', 'upperLimit': '70.76'}, {'value': '0.0', 'groupId': 'OG009', 'lowerLimit': '0.00', 'upperLimit': '40.96'}, {'value': '0.0', 'groupId': 'OG010', 'lowerLimit': '0.00', 'upperLimit': '84.19'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 24 months', 'description': 'PSA 50 was defined as a ≥ 50% reduction from the baseline PSA. This PSA response had to be confirmed by a second consecutive value obtained at least three weeks later.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PSA response evaluable analysis set was defined as all participants who received at least one dose of AMG 340, had a measurable (i.e., \\> 0) PSA at baseline, and had the opportunity to be followed for at least nine weeks from the start of AMG 340 treatment.\n\nParticipants who stopped disease assessments prior to nine weeks were included in this analysis set if the data snapshot date was at least nine weeks after their first study dose date.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a 70% Reduction From Baseline in PSA (PSA70)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Dose A', 'description': 'Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).'}, {'id': 'OG001', 'title': 'Cohort 2: Dose B', 'description': 'Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG002', 'title': 'Cohort 3: Dose C', 'description': 'Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG003', 'title': 'Cohort 4: Dose D', 'description': 'Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG004', 'title': 'Cohort 5: Dose E', 'description': 'Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG005', 'title': 'Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG006', 'title': 'Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG007', 'title': 'Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG008', 'title': 'Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG009', 'title': 'Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG010', 'title': 'Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '97.50'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '97.50'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '70.76'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '52.18'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '45.93'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '45.93'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.00', 'upperLimit': '70.76'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.00', 'upperLimit': '52.18'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.00', 'upperLimit': '70.76'}, {'value': '0.0', 'groupId': 'OG009', 'lowerLimit': '0.00', 'upperLimit': '40.96'}, {'value': '0', 'groupId': 'OG010', 'lowerLimit': '0.00', 'upperLimit': '84.19'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 24 months', 'description': 'PSA 70 was defined as a ≥ 70% reduction from the baseline PSA. This PSA response had to be confirmed by a second consecutive value obtained at least three weeks later.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PSA response evaluable analysis set was defined as all participants who received at least one dose of AMG 340, had a measurable (i.e., \\> 0) PSA at baseline, and had the opportunity to be followed for at least nine weeks from the start of AMG 340 treatment.\n\nParticipants who stopped disease assessments prior to nine weeks were included in this analysis set if the data snapshot date was at least nine weeks after their first study dose date.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a 90% Reduction From Baseline in PSA (PSA90)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Dose A', 'description': 'Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).'}, {'id': 'OG001', 'title': 'Cohort 2: Dose B', 'description': 'Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG002', 'title': 'Cohort 3: Dose C', 'description': 'Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG003', 'title': 'Cohort 4: Dose D', 'description': 'Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG004', 'title': 'Cohort 5: Dose E', 'description': 'Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG005', 'title': 'Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG006', 'title': 'Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG007', 'title': 'Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG008', 'title': 'Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG009', 'title': 'Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG010', 'title': 'Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '97.50'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '97.50'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '70.76'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '52.18'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '45.93'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.00', 'upperLimit': '45.93'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.00', 'upperLimit': '70.76'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.00', 'upperLimit': '52.18'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.00', 'upperLimit': '70.76'}, {'value': '0.0', 'groupId': 'OG009', 'lowerLimit': '0.00', 'upperLimit': '40.96'}, {'value': '0.0', 'groupId': 'OG010', 'lowerLimit': '0.00', 'upperLimit': '84.19'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 24 months', 'description': 'PSA 90 was defined as a ≥ 90% reduction from the baseline PSA. This PSA response had to be confirmed by a second consecutive value obtained at least three weeks later.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PSA response evaluable analysis set was defined as all participants who received at least one dose of AMG 340, had a measurable (i.e., \\> 0) PSA at baseline, and had the opportunity to be followed for at least nine weeks from the start of AMG 340 treatment.\n\nParticipants who stopped disease assessments prior to nine weeks were included in this analysis set if the data snapshot date was at least nine weeks after their first study dose date.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) Per RECIST 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Dose A', 'description': 'Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).'}, {'id': 'OG001', 'title': 'Cohort 2: Dose B', 'description': 'Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG002', 'title': 'Cohort 3: Dose C', 'description': 'Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG003', 'title': 'Cohort 4: Dose D', 'description': 'Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG004', 'title': 'Cohort 5: Dose E', 'description': 'Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG005', 'title': 'Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG006', 'title': 'Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG007', 'title': 'Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG008', 'title': 'Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG009', 'title': 'Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG010', 'title': 'Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}], 'timeFrame': 'Up to approximately 24 months', 'description': 'DOR was defined as the time from the date of an initial objective response per RECIST 1.1, which was subsequently confirmed, until soft-tissue progression per RECIST 1.1 or death, whichever occurred first in the absence of subsequent anti-cancer therapy. Participants who had not ended their response at the time of analysis had DOR censored at their last evaluable tumor assessment by CT/MRI scan prior to subsequent anti-cancer therapy. This endpoint only applied to participants with an objective response (CR or PR) per RECIST 1.1. No participants achieved CR or PR, therefore, no participants could be analyzed for this outcome measure.', 'reportingStatus': 'POSTED', 'populationDescription': 'RECIST 1.1 Evaluable Analysis Set: All participants who received at least one dose of AMG 340, had measurable disease per RECIST 1.1 at baseline, and had the opportunity to be followed for at least six weeks from the start of AMG 340 treatment. Participants who stopped disease assessments prior to six weeks were included in this analysis set if the data snapshot date was at least six weeks after their first study dose date.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Symptomatic Skeletal Events (SSE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Dose A', 'description': 'Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).'}, {'id': 'OG001', 'title': 'Cohort 2: Dose B', 'description': 'Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG002', 'title': 'Cohort 3: Dose C', 'description': 'Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG003', 'title': 'Cohort 4: Dose D', 'description': 'Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG004', 'title': 'Cohort 5: Dose E', 'description': 'Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'OG005', 'title': 'Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG006', 'title': 'Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG007', 'title': 'Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG008', 'title': 'Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG009', 'title': 'Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'OG010', 'title': 'Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 24 months', 'description': 'SSE was defined as time from study day 1 to the first symptomatic skeletal event, otherwise time to symptomatic skeletal event was censored at the last dose of AMG 340 or end of safety follow-up date, whichever was later.', 'unitOfMeasure': 'Number of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS: All participants who received at least 1 dose of AMG 340.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: AMG 340 Dose A', 'description': 'Participants with progressive mCRPC received AMG 340 Dose A administered as an intravenous (IV) infusion every 3 week (Q3W) in 21-day cycles.'}, {'id': 'FG001', 'title': 'Cohort 2: AMG 340 Dose B', 'description': 'Participants with progressive mCRPC received AMG 340 Dose B administered as an IV infusion Q3W in 21-day cycles.'}, {'id': 'FG002', 'title': 'Cohort 3: AMG 340 Dose C', 'description': 'Participants with progressive mCRPC received AMG 340 Dose C administered as an IV infusion Q3W every 21-day cycle.'}, {'id': 'FG003', 'title': 'Cohort 4: AMG 340 Dose D', 'description': 'Participants with progressive mCRPC received AMG 340 Dose D administered as an IV infusion Q3W in 21-day cycles.'}, {'id': 'FG004', 'title': 'Cohort 5: AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 Dose E administered as an IV infusion Q3W in 21-day cycles.'}, {'id': 'FG005', 'title': 'Cohort 6a: AMG 340 Priming Dose (PmD) (High) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 (high) PmD on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'FG006', 'title': 'Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'FG007', 'title': 'Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'FG008', 'title': 'Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'FG009', 'title': 'Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'FG010', 'title': 'Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '7'}, {'groupId': 'FG010', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '7'}, {'groupId': 'FG010', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '4'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Decision by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants with progressive metastatic castrate-resistant prostate carcinoma (mCRPC) participated in the study from April 2021 to June 2024, and were enrolled across 6 sites in the United States.', 'preAssignmentDetails': 'The study was designed to consist of two parts: a monotherapy dose escalation (Part A) and a monotherapy dose expansion (Part B). For strategic reasons, the study was terminated before enrollment into Part B could begin. Dose A is the lowest dose, Dose I is the highest dose.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '42', 'groupId': 'BG011'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: Dose A', 'description': 'Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W).'}, {'id': 'BG001', 'title': 'Cohort 2: Dose B', 'description': 'Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'BG002', 'title': 'Cohort 3: Dose C', 'description': 'Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'BG003', 'title': 'Cohort 4: Dose D', 'description': 'Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'BG004', 'title': 'Cohort 5: Dose E', 'description': 'Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W.'}, {'id': 'BG005', 'title': 'Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'BG006', 'title': 'Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'BG007', 'title': 'Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'BG008', 'title': 'Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'BG009', 'title': 'Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'BG010', 'title': 'Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I', 'description': 'Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles.\n\nFollowing protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5.'}, {'id': 'BG011', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '78.0', 'spread': 'NA', 'comment': 'Not estimable due to only one participant in the analysis.', 'groupId': 'BG000'}, {'value': '54.0', 'spread': 'NA', 'comment': 'Not estimable due to only one participant in the analysis.', 'groupId': 'BG001'}, {'value': '69.0', 'spread': '1.7', 'groupId': 'BG002'}, {'value': '67.6', 'spread': '7.4', 'groupId': 'BG003'}, {'value': '71.8', 'spread': '9.2', 'groupId': 'BG004'}, {'value': '59.2', 'spread': '6.4', 'groupId': 'BG005'}, {'value': '75.7', 'spread': '9.0', 'groupId': 'BG006'}, {'value': '70.8', 'spread': '5.2', 'groupId': 'BG007'}, {'value': '67.0', 'spread': '2.6', 'groupId': 'BG008'}, {'value': '69.9', 'spread': '4.5', 'groupId': 'BG009'}, {'value': '71.0', 'spread': '12.7', 'groupId': 'BG010'}, {'value': '68.5', 'spread': '7.8', 'groupId': 'BG011'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '42', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '41', 'groupId': 'BG011'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '38', 'groupId': 'BG011'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis set (SAS): All participants who received at least 1 dose of AMG 340.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-07', 'size': 2478234, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-04-23T08:50', 'hasProtocol': True}, {'date': '2024-07-31', 'size': 373558, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-04-23T08:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'whyStopped': 'Sponsor strategic decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-30', 'studyFirstSubmitDate': '2021-02-01', 'resultsFirstSubmitDate': '2025-04-23', 'studyFirstSubmitQcDate': '2021-02-01', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-30', 'studyFirstPostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months', 'description': 'An adverse event (AE) was any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. A treatment-related AE (TRAE) was defined as any TEAE flagged as possibly caused by AMG 340. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. Serious TEAEs (SAEs) were any untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused significant disability, resulted in congenital anomalies, or were considered other medically important events.'}, {'measure': 'Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)', 'timeFrame': 'Up to approximately Day 21', 'description': "A DLT was defined as a TEAE that was not unequivocally due to the participant's underlying malignancy or other extraneous cause, and appeared within 21 days from the first dose of AMG 340. AEs considered DLTs were:\n\n* Transient (≤72 hours) grade 3 or 4 electrolyte abnormalities, hyperglycemia, nausea/vomiting/diarrhea responsive to treatment.\n* Alopecia, vitiligo, and grade 3 fatigue lasting \\<10 days.\n* Grade 3 fever lasting ≤24 hours (outside CRS context).\n* Grade 3 lab abnormalities resolving within 72 hours (or within 7 days for certain enzymes like ALT, GGT, ALP, and lipase).\n* Grade 3 CRS or TLS unresolved to ≤ grade 1 within 72 hours or any grade 4 CRS/TLS.\n* Prolonged grade 4 neutropenia (\\>5 days) or febrile neutropenia.\n* Grade 3 thrombocytopenia with bleeding or any grade 4 thrombocytopenia.\n* Grade 4 anemia.\n* Grade 5 adverse events.\n* Lymphopenia is not considered a DLT."}, {'measure': 'Median Concentration of AMG 340', 'timeFrame': 'Cohorts 1-5: Days 1 (pre-dose to 6 hours post-dose), 2, 3, 8, and 10; Cohorts 6-10: Days 1 (pre-dose to 6 hours post-dose), 2, 3, 5 (pre-dose to 6 hours post-dose), 6, 7, 8 (pre-dose to 6 hours post-dose), 9, 10', 'description': 'Blood samples for pharmacokinetics (PK) analysis were collected at specific time points. PK parameters were estimated using standard non-compartmental approaches.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved an Objective Response (OR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1', 'timeFrame': 'Up to approximately 24 months', 'description': 'OR was defined as a partial response (PR) or complete response (CR) per RECIST 1.1, confirmed by a repeat assessment at least 4 weeks later. Participants who did not experience a confirmed PR/CR or did not have any follow-up tumor assessments were regarded as non-responders.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 24 months', 'description': 'OS was defined as the time from the date of study Day 1 until death due to any cause.'}, {'measure': 'Prostate Specific Antigen (PSA) Progression Free Survival (PFS)', 'timeFrame': 'Up to approximately 24 months', 'description': 'PSA PFS was defined as the interval from study day 1 to the earlier of a PSA progression or death from any cause; otherwise, PSA PFS was censored on the date of the last PSA measurement. If a participant had no baseline or post-baseline PSA measurement and a vital status of alive or unknown, PSA PFS was censored at study day 1.'}, {'measure': 'Radiographic PFS (rPFS)', 'timeFrame': 'Up to approximately 24 months', 'description': 'rPFS was defined as the interval from study day 1 to radiographic progression or death from any cause, whichever occurred first, in the absence of subsequent anti-cancer therapy; otherwise, rPFS was censored at the last evaluable tumor assessment date prior to subsequent anti-cancer therapy.\n\nIf a participant had no post-baseline radiographic tumor assessment and a vital status of alive or unknown, rPFS was censored at study day 1.'}, {'measure': 'Percentage of Participants With rPFS at 6 Months', 'timeFrame': '6 months', 'description': 'rPFS was defined as the interval from study day 1 to radiographic progression or death from any cause, whichever occurred first, in the absence of subsequent anti-cancer therapy; otherwise, rPFS was censored at the last evaluable tumor assessment date prior to subsequent anti-cancer therapy.\n\nIf a participant had no post-baseline radiographic tumor assessment and a vital status of alive or unknown, rPFS was censored at study day 1.'}, {'measure': 'Percentage of Participants With a 30% Reduction From Baseline in PSA (PSA30)', 'timeFrame': 'Up to approximately 24 months', 'description': 'PSA 30 was defined as a ≥ 30% reduction from the baseline PSA. This PSA response had to be confirmed by a second consecutive value obtained at least three weeks later.'}, {'measure': 'Percentage of Participants With a 50% Reduction From Baseline in PSA (PSA50)', 'timeFrame': 'Up to approximately 24 months', 'description': 'PSA 50 was defined as a ≥ 50% reduction from the baseline PSA. This PSA response had to be confirmed by a second consecutive value obtained at least three weeks later.'}, {'measure': 'Percentage of Participants With a 70% Reduction From Baseline in PSA (PSA70)', 'timeFrame': 'Up to approximately 24 months', 'description': 'PSA 70 was defined as a ≥ 70% reduction from the baseline PSA. This PSA response had to be confirmed by a second consecutive value obtained at least three weeks later.'}, {'measure': 'Percentage of Participants With a 90% Reduction From Baseline in PSA (PSA90)', 'timeFrame': 'Up to approximately 24 months', 'description': 'PSA 90 was defined as a ≥ 90% reduction from the baseline PSA. This PSA response had to be confirmed by a second consecutive value obtained at least three weeks later.'}, {'measure': 'Duration of Response (DOR) Per RECIST 1.1', 'timeFrame': 'Up to approximately 24 months', 'description': 'DOR was defined as the time from the date of an initial objective response per RECIST 1.1, which was subsequently confirmed, until soft-tissue progression per RECIST 1.1 or death, whichever occurred first in the absence of subsequent anti-cancer therapy. Participants who had not ended their response at the time of analysis had DOR censored at their last evaluable tumor assessment by CT/MRI scan prior to subsequent anti-cancer therapy. This endpoint only applied to participants with an objective response (CR or PR) per RECIST 1.1. No participants achieved CR or PR, therefore, no participants could be analyzed for this outcome measure.'}, {'measure': 'Number of Participants With Symptomatic Skeletal Events (SSE)', 'timeFrame': 'Up to approximately 24 months', 'description': 'SSE was defined as time from study day 1 to the first symptomatic skeletal event, otherwise time to symptomatic skeletal event was censored at the last dose of AMG 340 or end of safety follow-up date, whichever was later.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate specific membrane antigen', 'PSMA', 'Prostate cancer', 'Metastatic', 'Castrate-resistant'], 'conditions': ['Metastatic Castration-resistant Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of AMG 340, a PSMA x CD3 T-cell engaging bispecific antibody, in subjects with metastatic castrate-resistant prostate cancer (mCRPC) who have received 2 or more prior lines of therapy. The study consists of 2 parts, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B). Once the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identified in Arm A, Arm B will be initiated to further characterize the safety, tolerability and pharmacokinetic (PK) profile of the MTD/RP2D dose of AMG 340 monotherapy in subjects with mCRPC.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pathologically confirmed prostatic adenocarcinoma.\n* History of metastatic disease.\n* Chemically or surgically castrate.\n* Subject has received at least 2 lines of systemic therapy approved for mCRPC, with disease progression on the most recent systemic therapy as defined in Prostate Cancer Working Group 3 (PCWG3) recommendations.\n* Human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV)-infected subjects that have been cured or who are on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* An Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.\n* Subject must have adequate heart, liver, bone marrow and kidney function (e.g. estimated glomerular filtration rate \\[eGFR\\] ≥ 50 mL/min, aspartate aminotransferase \\[AST\\]/alanine aminotransferase \\[ALT\\] ≤ 3 x upper limit of normal \\[ULN\\], hemoglobin \\[Hgb\\] ≥ 9 g/dL (without blood transfusion within 7 days from screening assessment), platelets ≥ 100,000 / mm\\^3 (without platelet transfusion within 7 days from screening assessment), absolute neutrophil count \\[ANC\\] ≥ 1500 / mm\\^3).\n\nExclusion Criteria:\n\n* Subject has been diagnosed with or treated for another malignancy within the past 2 years whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen.\n* History of neuroendocrine differentiation in the subject's disease.\n* Subject has a history of central nervous system (CNS) involvement by their mCRPC. Metastases stemming from bone are allowed.\n* Subject has clinically significant CNS pathology.\n* Subject requires chronic immunosuppressive therapy.\n* Subject has a history of major cardiac abnormalities."}, 'identificationModule': {'nctId': 'NCT04740034', 'briefTitle': 'A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of AMG 340, a Bispecific Antibody Targeting PSMA in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma', 'orgStudyIdInfo': {'id': 'TNB585.001'}, 'secondaryIdInfos': [{'id': '20210249', 'type': 'OTHER', 'domain': 'Amgen'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation', 'description': 'Sequential dose escalation cohorts are planned until maximum tolerated dose (MTD) is reached or recommended phase 2 dose (RP2D) is identified.', 'interventionNames': ['Drug: AMG 340']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion', 'description': 'An expansion cohort in subjects with mCRPC will be enrolled after RP2D is established.', 'interventionNames': ['Drug: AMG 340']}], 'interventions': [{'name': 'AMG 340', 'type': 'DRUG', 'description': 'AMG 340 is a bispecific antibody targeting prostate-specific membrane antigen (PSMA) on tumor cells and CD3 on T-cells', 'armGroupLabels': ['Dose Escalation', 'Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute at HealthONE', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane Cancer Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '10128', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University - Sidney Kimmel Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}