PHASE 2 STUDY OF IMC-001 IN PATIENTS WITH METASTATIC OR LOCALLY ADVANCED TMB-H SOLID TUMOR

IMC-001-202

The goal of this clinical trial is to determine the efficacy of IMC-001 in metastatic or locally advanced TMB-H solid tumor patients.

2024-06-01

2025-12-01

2027-12-01

Not yet recruiting

Early phase I

30

Inclusion Criteria: 1. Documented TMB-H:≥ 16 mut/Mb, determined by the TruSightTM Oncology 500 NGS panel. 2. Prior systemic radiation therapy must be completed at least 4 weeks before the first dose of study drug. 3. Histologically or cytologically proven metastatic or locally advanced solid tumors.The participant must have at least one measurable tumor lesion per RECIST 1.1. 4. Adult age(as defined by respective country) 5. The nature of the study and voluntarily sign an ICF 6. ECOG 0 or1 7. Adequate hematologic function, hepatic function, and renal function Exclusion Criteria: 1. Previously treated with an anti-PD-L1 or anti-PD-1 antibody 2. Known presence of symptomatic CNS metastases 3. Any active autoimmune disease or a documented history of autoimmune disease 4. Apparent active and known viral infection with HIV, hepatitis B virus or hepatitis C virus 5. Pregnant or lactating

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2024-04-15