Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 1:25 AM
Study NCT ID:
NCT03644056
Status:
COMPLETED
Last Update Posted:
2020-05-28
First Post:
2018-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-escalation Study of IMC-001 in Subject With Metastatic or Locally-advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722928', 'term': 'IMC-001'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-26', 'studyFirstSubmitDate': '2018-08-17', 'studyFirstSubmitQcDate': '2018-08-21', 'lastUpdatePostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of DLTs', 'timeFrame': 'During the first 21 days of treatment', 'description': 'To investigate the occurrence of DLTs of IMC-001 treatment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IMC-001'], 'conditions': ['Solid Tumor', 'Metastasis', 'Locally Advanced']}, 'referencesModule': {'references': [{'pmid': '34268711', 'type': 'DERIVED', 'citation': 'Keam B, Ock CY, Kim TM, Oh DY, Kang WK, Park YH, Lee J, Lee JH, Ahn YH, Kim HJ, Chang SK, Park J, Choi JY, Song YJ, Park YS. A phase I study of IMC-001, a PD-L1 blocker, in patients with metastatic or locally advanced solid tumors. Invest New Drugs. 2021 Dec;39(6):1624-1632. doi: 10.1007/s10637-021-01078-6. Epub 2021 Jul 16.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase 1, Open-label, Multiple-ascending Dose Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of IMC-001 in Subjects with Metastatic or Locally-advanced Solid Tumors', 'detailedDescription': 'IMC-001 is a PD-L1 targeting, fully human monoclonal antibody. The purpose of this study is to determine safety and evaluate PK, PD and clinical activity of IMC-001. Multiple dose levels of IMC-001 will be tested in subjects with metastatic or locally-advanced solid tumors. Data from this study will also help determine the recommended phase 2 dose of IMC-001.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed Informed Consent Form (ICF).\n2. Adult (19 years or older).\n3. Histologically or cytologically proven metastatic or locally-advanced solid tumors\n\nExclusion Criteria:\n\n1. Treatment with non-permitted drugs (within the past 28 days of Screening), including but not limited to systemic immunosuppressive agents, any other investigational medicinal product (IMP), anti-coagulant, or live vaccines.\n2. Any prior cancer immunotherapy\n3. Concurrent anticancer treatments'}, 'identificationModule': {'nctId': 'NCT03644056', 'briefTitle': 'Dose-escalation Study of IMC-001 in Subject With Metastatic or Locally-advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'ImmuneOncia Therapeutics Inc.'}, 'officialTitle': 'A Phase 1, Open-label, Multiple-ascending Dose Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of IMC-001 in Subjects With Metastatic or Locally-advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'IMC-001-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMC-001', 'description': 'Multiple Dose Level (IMC-001 2 mg/kg etc. every 2 weeks)', 'interventionNames': ['Drug: IMC-001']}], 'interventions': [{'name': 'IMC-001', 'type': 'DRUG', 'otherNames': ['Not confirm yet'], 'description': 'Different IMC-001 dose level for each cohort group (IMC-001 2 mg/kg etc. every 2 weeks)', 'armGroupLabels': ['IMC-001']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17084', 'city': 'Yongin-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'ImmuneOncia', 'geoPoint': {'lat': 37.29686, 'lon': 127.08042}}], 'overallOfficials': [{'name': 'Yun Jeong Song, CMO/CEO', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ImmuneOncia Therapeutics Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ImmuneOncia Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}