A Study of CM350 in Patients With Advanced Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open label, dose escalation and expansion Phase I/II study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of CM350 in patients with advanced solid tumors.

The phase I study consists of a dose escalation part (Part A) and a dose extension part (Part B).

The safety and tolerability of CM350 and the maximum tolerated dose (MTD) will be evaluated in Part A.

The safety, tolerability and efficacy of CM350 at MTD and/or the dose of one level less than MTD (MTD-1), and the recommended dose level for the phase II study will be determined in Part B.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Keymed Biosciences Co.Ltd

Criteria

Inclusion Criteria:

• Dose escalation part of Phase I study : Patient with histologically or cytologically confirmed advanced solid tumors for which standard treatment do not exist, are no longer effective, or are not acceptable to the patient.

• Dose expansion part of Phase I study : Patient with histologically or cytologically confirmed IHC GPC3-positive advanced solid tumors for which standard treatment do not exist, are no longer effective, or are not acceptable to the patient.

Exclusion Criteria:

• Patients who received any cytotoxic chemotherapy agent, radiotherapy, targeted therapy, biotherapy, antitumor traditional Chinese medicine, or any other investigational antitumor agent within 28 days prior to first dosing of CM350.

• Had major surgery within 28 days prior to first dosing of CM350.

• Received any antibodies/drugs/therapies targeting T-cell co-regulatory proteins (immune checkpoints) within 28 days or 5 half-lives (whichever is shorter) prior to first dosing of CM350, including but not limited to cytokine therapy, anti-programmed death receptor 1 (PD-1), anti-programmed death receptor ligand-1 (PD-L1), anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), chimeric antigen receptor T cell (CAR T) therapy, etc.

• Received therapies targeting GPC3, including but not limited to monoclonal antibodies, peptide vaccines, chimeric antigen receptor T cells (CAR-T), and bispecific antibodies.