Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CM369 in Subjects With Advanced Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2025-04-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a nonrandomized, open-label, multicenter, phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of CM369 in subjects with advanced solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Criteria

Inclusion Criteria:

1. Life expectancy ≥12 weeks.

2. Eastern Cooperative Oncology Group performance status of 0-1.

3. Subjects with cytology and/or histologically confirmed locally advanced unresectable or metastatic solid tumors.

4. Agree to provide archived tumor tissue samples of primary or metastatic lesions.

5. Phase Ia: have at least one measurable lesion or one evaluable lesion according to RECIST 1.1.

6. Have adequate organ function as described in the protocol.

Exclusion Criteria:

1. Subjects with primary central nervous system (CNS) tumors or unstable CNS metastases.

2. Subjects who have uncontrollable or major cardiovascular disease refer to protocol.

3. Subjects who have an active autoimmune disease or have had an autoimmune disease with risk of recurrence.

4. Subjects who have active or history of interstitial lung disease or non-infectious pneumonia.

5. Subjects with any active infection requiring systemic treatment by intravenous infusion within 14 days prior to the first administration of the study drug.

6. HIV infection; Hepatitis C virus (HCV) antibody positive; HCV infection.

7. History of active bleeding within 2 months before screening, or bleeding symptoms associated with application of anticoagulant drugs or other interventions.

8. Have not recovered to CTCAE Grade 1 or better from the adverse events due to previous cancer therapies.

9. Subjects who received systemic immunosuppressive drugs within 14 days prior to the first administration of the study drug.

10. Subjects who require systemic treatment of corticosteroids or other immunosuppressive agents within 14 days prior to first dose.

11. Has a history of severe allergic reactions to monoclonal antibodies.

12. Subjects with any mental or cognitive impairment that may limit their understanding, implementation.