Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-29 @ 8:11 AM
Study NCT ID:
NCT01646203
Status:
COMPLETED
Last Update Posted:
2019-01-18
First Post:
2012-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of IMC-TR1 in Participants With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000620254', 'term': 'LY3022859'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Maximum Tolerated Dose (MTD) was not reached. Dose escalation beyond 25 mg LY3022859 was not completed due to DLT. Two participants who received 1.25 mg/kg required permanent interruption of administration because they developed DLT.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '1.25 mg/kg LY3022859', 'description': 'Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '12.5 mg LY3022859', 'description': 'Cohorts 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.', 'otherNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': '25 mg LY3022859', 'description': 'Cohorts 2: 25 mg IV once Q2W during 6-week treatment cycles.', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gingival inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cytokine release syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Blood chloride decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lymphocyte count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Occult blood positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Troponin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Glucose tolerance impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Joint range of motion decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Emotional distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Retroperitoneal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Dose-Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 mg/kg LY3022859', 'description': 'Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.'}, {'id': 'OG001', 'title': '12.5 mg LY3022859', 'description': 'Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.'}, {'id': 'OG002', 'title': '25 mg LY3022859', 'description': 'Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First Dose Up to 6 Weeks', 'description': "A DLT was defined as an AE occurring during Cycle 1(first 6 weeks of treatment) that was considered at least possibly related to study drug, was considered dose-dependent, and fulfilled a criteria selected (using the National Cancer Institute Common Terminology Criteria for Adverse Events,version 4.0 \\[NCI-CTCAE v 4.0\\] \\[NCI 2009\\]):Grade(Gr)≥3 nonhematological toxicity,Gr4 thrombocytopenia lasting at least 5 days and/or complicated with bleeding,Gr≥3 febrile neutropenia(ntr),Gr4 ntr of \\>5 days' duration,increase(incr)of at least 1 gr from a preexisting Gr1 valvular insufficiency or any new Gr≥2 valvular toxicity,left ventricular(vtr) ejection fraction decrease of 10% in absolute value or 16% in relative value,incr in right vtr systolic pressure dysfunction from mild to moderate(mod) or from mod to severe,incr in left atrial or ventricular chamber size of ≥2 cm and ≥1cm respectively,any other life-threatening toxicity,significant morphologic on cardiac echocardiogram,any major ocular.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Maximum Tolerated Dose (MTD) of IMC-TR1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants Receiving a Flat Dose', 'description': '12.5 mg LY3022859 Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.\n\n25 mg LY3022859 Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'MTD was not reached.', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First Dose through Cycle 1 (6 Weeks)', 'description': 'The MTD was defined as the highest dose level at which ≤33% of participants experienced a DLT during Cycle 1.', 'unitOfMeasure': 'milligram (mg)', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and completed cycle 1 or discontinued treatment due to a DLT during the cycle 1.'}, {'type': 'SECONDARY', 'title': 'Maximum Tolerated Dose (MTD) of IMC-TR1 (1.25 mg/kg LY3022859 ) for Participants Receiving a Weight-Based Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants Receiving a Weight-Based Dose', 'description': '1.25 mg/kg LY3022859 Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'MTD was not reached.', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First Dose through Cycle 1 (6 Weeks)', 'description': 'The MTD was defined as the highest dose level at which ≤33% of participants experienced a DLT during Cycle 1.', 'unitOfMeasure': 'milligram/kilogram (mg/kg)', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and completed cycle 1 or discontinued treatment due to a DLT during the cycle 1.'}, {'type': 'SECONDARY', 'title': 'Number of Dose-Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 mg/kg LY3022859', 'description': 'Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.'}, {'id': 'OG001', 'title': '12.5 mg LY3022859', 'description': 'Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.'}, {'id': 'OG002', 'title': '25 mg LY3022859', 'description': 'Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First Dose through Cycle 1 (6 Weeks)', 'unitOfMeasure': 'DLTs', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity - Development of Antibodies Against IMC-TR1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 mg/kg LY3022859', 'description': 'Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.'}, {'id': 'OG001', 'title': '12.5 mg LY3022859', 'description': 'Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.'}, {'id': 'OG002', 'title': '25 mg LY3022859', 'description': 'Cohort 2: 25mg IV once Q2W during 6-week treatment cycles.'}], 'timeFrame': 'Cycle 1 - Day 1 and Day 29, Cycle 2 - Day 15, Cycle 3 and Each Consecutive Cycle - Day 1', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed. Immunogenicity data were not collected.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) (Antitumor Activity of IMC-TR1 as Monotherapy, Assessed Via Tumor Measurement by Response Evaluation Criteria in Solid Tumors, Version 1.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 mg/kg LY3022859', 'description': 'Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.'}, {'id': 'OG001', 'title': '12.5 mg LY3022859', 'description': 'Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.'}, {'id': 'OG002', 'title': '25 mg LY3022859', 'description': 'Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '84.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '52.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '41.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First Dose to Measured Progressive Disease (Up To 21.3 Weeks)', 'description': 'ORR is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK) - Area Under the Concentration-time Curve (AUC[0-tlast]) and AUCτ of IMC-TR1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '12.5 mg LY3022859', 'description': 'Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.'}, {'id': 'OG001', 'title': '25 mg LY3022859', 'description': 'Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.'}], 'classes': [{'title': 'Cycle 1 (AUC[0-tlast])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.5', 'spread': '18', 'groupId': 'OG000'}, {'value': '60.2', 'spread': '30', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 (AUCτ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.7', 'spread': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle (C) 1 Day (D) 1: 1, 2, 4, 8 hours (h); C1 D2: 24 h; C1 D3: 48 h; C1 D5: 96 h; C1 D8: 168 h; C1 D15: 336 h; C2 D15: 1, 2, 4, 8 h; C2 D16: 24 h; C2 D17: 48 h; C2 D19: 96 h; C2 D22: 168 h, C2 D29: 336 h', 'description': 'AUC (0-tlast) is area under the concentration versus time curve from the time zero to tlast.\n\nAUCτ is area under the concentration versus time curve during 1 dose interval (336 hours).', 'unitOfMeasure': 'microgram*hour per milliliter(µg·hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable PK data. PK of LY3022859 was not characterized at the 1.25-mg/kg dose level because of infusion interruptions thus no data collected.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics - Maximum Concentration (Cmax) of IMC-TR1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '12.5 mg LY3022859', 'description': 'Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.'}, {'id': 'OG001', 'title': '25 mg LY3022859', 'description': 'Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.34', 'spread': '9', 'groupId': 'OG000'}, {'value': '5.10', 'spread': '21', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.52', 'spread': '9', 'groupId': 'OG000'}, {'value': '5.01', 'spread': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle (C) 1 Day (D) 1: 1, 2, 4, 8 hours (h); C1 D2: 24 h; C1 D3: 48 h; C1 D5: 96 h; C1 D8: 168 h; C1 D15: 336 h; C2 D15: 1, 2, 4, 8 h; C2 D16: 24 h; C2 D17: 48 h; C2 D19: 96 h; C2 D22: 168 h, C2 D29: 336 h', 'unitOfMeasure': 'microgram per milliliter (µg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable PK data. PK of LY3022859 was not characterized at the 1.25 mg/kg dose level because of infusion interruptions thus no data collected.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics - Minimum Concentration (Cmin) of IMC-TR1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '12.5 mg LY3022859', 'description': 'Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.'}, {'id': 'OG001', 'title': '25 mg LY3022859', 'description': 'Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Concentrations were below the limit of quantification.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Concentrations were below the limit of quantification.', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2 Day 1: Prior to fourth infusion 0 hour (h)', 'description': 'Pharmacokinetics - Minimum concentration (Cmin) of IMC-TR1', 'unitOfMeasure': 'microgram/milliliter (µg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable PK data. PK of LY3022859 was not characterized at the 1.25 mg/kg dose level because of infusion interruptions thus no data collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1.25 mg/kg LY3022859', 'description': 'Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.'}, {'id': 'FG001', 'title': '12.5 mg LY3022859', 'description': 'Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.'}, {'id': 'FG002', 'title': '25 mg LY3022859', 'description': 'Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': "Physician's Decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants that completed Cohort 1A, Cohort 1B or Cohort 2 are those who died, had progressive disease (PD) or off treatment \\& censored due to study completion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '1.25 mg/kg LY3022859', 'description': 'Cohort 1A: 1.25 milligram/kilogram (mg/kg) LY3022859 administered intravenously (IV) once every 2 weeks (Q2W) during 6-week treatment cycles.'}, {'id': 'BG001', 'title': '12.5 mg LY3022859', 'description': 'Cohort 1B: 12.5 mg IV once Q2W during 6-week treatment cycles.'}, {'id': 'BG002', 'title': '25 mg LY3022859', 'description': 'Cohort 2: 25 mg IV once Q2W during 6-week treatment cycles.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.5', 'spread': '19.09', 'groupId': 'BG000'}, {'value': '62.2', 'spread': '9.44', 'groupId': 'BG001'}, {'value': '55.0', 'spread': '16.80', 'groupId': 'BG002'}, {'value': '59.1', 'spread': '14.31', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-03', 'studyFirstSubmitDate': '2012-06-11', 'resultsFirstSubmitDate': '2017-09-27', 'studyFirstSubmitQcDate': '2012-07-18', 'lastUpdatePostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-03', 'studyFirstPostDateStruct': {'date': '2012-07-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Dose-Limiting Toxicities (DLTs)', 'timeFrame': 'First Dose Up to 6 Weeks', 'description': "A DLT was defined as an AE occurring during Cycle 1(first 6 weeks of treatment) that was considered at least possibly related to study drug, was considered dose-dependent, and fulfilled a criteria selected (using the National Cancer Institute Common Terminology Criteria for Adverse Events,version 4.0 \\[NCI-CTCAE v 4.0\\] \\[NCI 2009\\]):Grade(Gr)≥3 nonhematological toxicity,Gr4 thrombocytopenia lasting at least 5 days and/or complicated with bleeding,Gr≥3 febrile neutropenia(ntr),Gr4 ntr of \\>5 days' duration,increase(incr)of at least 1 gr from a preexisting Gr1 valvular insufficiency or any new Gr≥2 valvular toxicity,left ventricular(vtr) ejection fraction decrease of 10% in absolute value or 16% in relative value,incr in right vtr systolic pressure dysfunction from mild to moderate(mod) or from mod to severe,incr in left atrial or ventricular chamber size of ≥2 cm and ≥1cm respectively,any other life-threatening toxicity,significant morphologic on cardiac echocardiogram,any major ocular."}], 'secondaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD) of IMC-TR1', 'timeFrame': 'First Dose through Cycle 1 (6 Weeks)', 'description': 'The MTD was defined as the highest dose level at which ≤33% of participants experienced a DLT during Cycle 1.'}, {'measure': 'Maximum Tolerated Dose (MTD) of IMC-TR1 (1.25 mg/kg LY3022859 ) for Participants Receiving a Weight-Based Dose', 'timeFrame': 'First Dose through Cycle 1 (6 Weeks)', 'description': 'The MTD was defined as the highest dose level at which ≤33% of participants experienced a DLT during Cycle 1.'}, {'measure': 'Number of Dose-Limiting Toxicities (DLTs)', 'timeFrame': 'First Dose through Cycle 1 (6 Weeks)'}, {'measure': 'Immunogenicity - Development of Antibodies Against IMC-TR1', 'timeFrame': 'Cycle 1 - Day 1 and Day 29, Cycle 2 - Day 15, Cycle 3 and Each Consecutive Cycle - Day 1'}, {'measure': 'Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) (Antitumor Activity of IMC-TR1 as Monotherapy, Assessed Via Tumor Measurement by Response Evaluation Criteria in Solid Tumors, Version 1.1)', 'timeFrame': 'First Dose to Measured Progressive Disease (Up To 21.3 Weeks)', 'description': 'ORR is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.'}, {'measure': 'Pharmacokinetics (PK) - Area Under the Concentration-time Curve (AUC[0-tlast]) and AUCτ of IMC-TR1', 'timeFrame': 'Cycle (C) 1 Day (D) 1: 1, 2, 4, 8 hours (h); C1 D2: 24 h; C1 D3: 48 h; C1 D5: 96 h; C1 D8: 168 h; C1 D15: 336 h; C2 D15: 1, 2, 4, 8 h; C2 D16: 24 h; C2 D17: 48 h; C2 D19: 96 h; C2 D22: 168 h, C2 D29: 336 h', 'description': 'AUC (0-tlast) is area under the concentration versus time curve from the time zero to tlast.\n\nAUCτ is area under the concentration versus time curve during 1 dose interval (336 hours).'}, {'measure': 'Pharmacokinetics - Maximum Concentration (Cmax) of IMC-TR1', 'timeFrame': 'Cycle (C) 1 Day (D) 1: 1, 2, 4, 8 hours (h); C1 D2: 24 h; C1 D3: 48 h; C1 D5: 96 h; C1 D8: 168 h; C1 D15: 336 h; C2 D15: 1, 2, 4, 8 h; C2 D16: 24 h; C2 D17: 48 h; C2 D19: 96 h; C2 D22: 168 h, C2 D29: 336 h'}, {'measure': 'Pharmacokinetics - Minimum Concentration (Cmin) of IMC-TR1', 'timeFrame': 'Cycle 2 Day 1: Prior to fourth infusion 0 hour (h)', 'description': 'Pharmacokinetics - Minimum concentration (Cmin) of IMC-TR1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Advanced Solid Tumors'], 'conditions': ['Neoplasms', 'Tumor']}, 'referencesModule': {'references': [{'pmid': '28280971', 'type': 'DERIVED', 'citation': 'Tolcher AW, Berlin JD, Cosaert J, Kauh J, Chan E, Piha-Paul SA, Amaya A, Tang S, Driscoll K, Kimbung R, Kambhampati SR, Gueorguieva I, Hong DS. A phase 1 study of anti-TGFbeta receptor type-II monoclonal antibody LY3022859 in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2017 Apr;79(4):673-680. doi: 10.1007/s00280-017-3245-5. Epub 2017 Mar 9.'}]}, 'descriptionModule': {'briefSummary': 'A study to evaluate the safety and tolerability of anti-TGFβRII monoclonal antibody (IMC-TR1) in participants with advanced solid tumors, as well as gather evidence of anti-tumor activity.', 'detailedDescription': 'This is the first-in-human Phase 1 study of IMC-TR1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Part A and Part B: Participants must be appropriate candidates for experimental therapy, with a solid tumor that has failed standard therapy or for which no standard therapy is available, and evidence of progressive disease\n\n * Part A only: Participants must have histological or cytological evidence of a solid tumor which is advanced and/or metastatic\n * Part B only: Participants who have failed first-line therapy/standard of care and have histological or cytological evidence of a cancer type for which evidence of activity was observed during Part A or for which preclinical evidence of potential activity has been observed\n* Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)\n\n * Part A only: Participants may have measurable or nonmeasurable disease\n * Part B: Participants must have measurable disease\n* Have adequate organ function including: Hematologic, Hepatic, Albumin, Coagulation and Renal function\n* Have a performance status of ≤ 1 on the Eastern Cooperative Oncology Group (ECOG) scale\n* Have discontinued previous treatments for cancer and recovered from the acute effects of therapy\n* Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug\n* Females with child bearing potential must have had a negative serum pregnancy test and must not be breastfeeding\n* Have an estimated life expectancy that is \\> 3 months\n\nExclusion Criteria:\n\n* Have clinically significant cardiac disease, including:\n\n * Myocardial infarction within 6 months prior to study entry, unstable angina pectoris, congestive heart failure, or uncontrolled hypertension\n * Major electrocardiogram (ECG) abnormalities\n * Major abnormalities documented by echocardiography with Doppler\n * Have known predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress\n * Have Corrected QT Interval (QTc interval) of \\> 500 msec on screening ECG\n* Have other known serious pre-existing medical conditions\n* Have received prior investigational therapy targeting Transforming growth factor beta (TGFβ) or its receptors\n* Have a known sensitivity to monoclonal antibodies or other therapeutic proteins, to agents of similar biologic composition as IMC-TR1\n* Have a high risk of gastrointestinal bleeding, active inflammatory bowel disease, or chronic steroid use\n* Are currently using or has received a systemic thrombolytic agent within 28 days prior to enrollment\n* Are receiving:\n\n * full-dose warfarin\n * intravenous heparin or low-molecular-weight heparin\n * chronic daily treatment with aspirin at a dose greater than 325 mg per day or nonsteroidal anti-inflammatory medications known to inhibit platelet function\n* Have evidence of retinal disease or are a monocular participant\n* Have received a solid organ transplant, bone marrow transplant or stem cell transplant\n* Have symptomatic central nervous system (CNS) malignancy or untreated metastasis\n* Have acute or chronic leukemia\n* Have a known active fungal, bacterial, and/or viral infection including human immunodeficiency virus or viral hepatitis requiring treatment\n* Has a positive fecal occult blood test within 14 days prior to enrollment'}, 'identificationModule': {'nctId': 'NCT01646203', 'briefTitle': 'A Study of IMC-TR1 in Participants With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Phase 1 Study of Anti-TGFβRII Monoclonal Antibody IMC-TR1 (LY3022859) in Patients With Advanced Solid Tumors That Have Failed Standard Therapy or for Which No Standard is Available', 'orgStudyIdInfo': {'id': '14549'}, 'secondaryIdInfos': [{'id': 'I5I-IE-JTCA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMC-TR1', 'description': 'Part A - Dose Escalation:\n\nCohort 1A: 1.25 mg/kg, intravenously (IV), every 2 weeks of the 6-week treatment cycle\n\nCohorts 1B-9: Dose Escalation from 12.5 mg to 1600 mg (flat dose), intravenously (IV), every 2 weeks of the 6-week treatment cycles\n\nCohorts 10-12: Dose escalation from 800 mg to 1600 mg (flat dose), intravenously (IV), weekly during the 6-week treatment cycles\n\nPart B - Disease Specific Cohort Expansion:\n\nParticipants will be enrolled into each of three tumor-specific cohort expansions. Participants will be treated with recommended Phase 2 dose.', 'interventionNames': ['Biological: IMC-TR1']}], 'interventions': [{'name': 'IMC-TR1', 'type': 'BIOLOGICAL', 'otherNames': ['LY3022859'], 'description': 'Administered intravenously', 'armGroupLabels': ['IMC-TR1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}