Actively Recruiting
A Study of CM350 in Patients With Advanced Solid Tumors
Led by Keymed Biosciences Co.Ltd · Updated on 2025-05-04
248
Participants Needed
2
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of CM350 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with confirmed advanced solid tumors that are resistant to, intolerable with, or lack standard treatments
- For hepatocellular cancer patients: BCLC stage B or C, or CNLC stage IIb or III, with no eligibility for surgery or locoregional treatments, or disease progression after such therapies
- Child-Pugh score of 7 or less for hepatocellular cancer patients
- Phase I dose escalation participants must have tumors that can be evaluated by RECIST 1.1 criteria
- Phase I dose expansion and Phase II participants must have at least one measurable tumor lesion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You will not qualify if you...
- Received cytotoxic chemotherapy, radiotherapy, biologic therapy, or investigational anticancer treatments within 28 days before first CM350 dose
- For palliative radiotherapy to non-brain lesions lasting 14 days or less, a 7-day minimum washout before first CM350 dose is required
- Received immunotherapy (including PD-1, PD-L1, CTLA-4, CAR-T) within 28 days or 5 half-lives before first CM350 dose
- Received targeted therapy within 28 days or 5 half-lives before first CM350 dose
- Prior treatment targeting glypican-3 including monoclonal antibodies, peptide vaccines, CAR-T, or bispecific antibodies
- Chronic systemic corticosteroid use over 10 mg prednisone (or equivalent) daily or other immunosuppressive therapy within 7 days before first CM350 dose
- Active central nervous system metastases unless previously treated and stable for at least 14 days confirmed by imaging
- Uncontrolled pleural effusion, ascites, or pericardial effusion
- History of other cancers within 5 years except cured basal or squamous cell skin cancer, cervical carcinoma in situ, or ductal carcinoma in situ of the breast
- Active infection at screening as determined by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
2
Zhongshan Hospital Affiliated to Fudan University
Shanghai, China
Actively Recruiting
Research Team
Q
Qian Jia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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