A Study of CM350 in Patients With Advanced Solid Tumors

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 phase and a dose expansion phase The safety and tolerability of CM350 and the maximum tolerated dose (MTD) (if applicable) will be evaluated in dose escalation phase. The recommended phase 2 dose (RP2D) of CM350 will be determined in dose expansion phase. The phase II study is to evaluate the efficacy of CM350 at the recommended phase 2 dose (RP2D) for advanced glypican-3 (GPC3)-positive solid tumors.

Timeline

Start

2022-04-21

Primary completion

2027-04

Completion

2027-04

Publications

• Zhou X, Liu Y, Liu X, Song X, Li S, Chen P, Jiang X, Li Y. Novel GPC3 N-terminal bispecific antibody exhibits dual anti-tumor effect against tumor cells. Invest New Drugs. 2025 Jun;43(3):588-601. doi: 10.1007/s10637-025-01530-x. Epub 2025 May 1.

Drugs

Indications