Clinical Trial

A Study of CM350 in Patients With Advanced Solid Tumors

Recruiting Phase 1/2
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-02-21; most recent amendment 2025-04-29.
Status change: Not Yet Recruiting → Recruiting 2022-06-06
Trial Details
NCT Number NCT05263960
Lead Sponsor Keymed Biosciences Co.Ltd
Conditions Advanced Solid Tumor
Enrollment 248 participants
Start Date 2022-04-21
Primary Completion 2027-04 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2025-05-04