An Open-Label, Dose-Escalation and Expansion, Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of IMC-002 in Patients With Advanced Cancer Failed to Standard Therapy

IMC-002-K102

This is an Open-Label, Dose-Escalation and Expansion, Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of IMC-002 in Patients with Advanced Cancer Failed to Standard Therapy

2022-05-10

2025-06-30

2026-12-31

Recruiting

Early phase I

49

Inclusion Criteria: 1. Signed ICF 2. Histologically or cytologically proven metastatic or locally advanced solid tumors 3. Subject must have at least 1 measurable lesion by RECIST 1.1. 4. Availability of tumor archival material or fresh biopsies 5. Adequate hematologic function, hepatic function, and renal function 6. Agree to use effective contraception 7. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures Exclusion Criteria: 1. Treatment with nonpermitted drugs 2. Prior treatment with a CD47 or SIRPα targeting agent 3. Concurrent anticancer treatments 4. Major surgery or significant traumatic injury prior to Screening or planned major surgery during the study period 5. Previous malignant disease other than the target malignancy for this study 6. Active infection requiring systemic therapy before Day 1 7. Any active autoimmune disease, or history of autoimmune disease 8. Any psychiatric or cognitive condition 9. Known severe hypersensitivity reaction 10. Pregnant or lactating 11. Currently enrolled in another clinical study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Part 1: Dose Escalation Part 2: Expansion cohort', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 49, 'type': 'ESTIMATED'}}

2024-04-12