Evaluating CM350 for patients with advanced solid tumors

A Multicenter, Open Label, Phase I/II Clinical Study of CM350 in Patients With Advanced Solid Tumors

This study is testing a new treatment called CM350 to see if it is safe and effective for people with advanced solid tumors that have a specific marker.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 248 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Keymed Biosciences Co.Ltd (industry)
• Drugs / interventions: CAR-T, chimeric antigen receptor, chemotherapy, immunotherapy, prednisone
• Locations: 2 sites (Chengdu, Sichuan and 1 other locations)
• Trial ID: NCT05263960 on ClinicalTrials.gov

What this trial studies

This open-label, dose escalation and expansion study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of CM350 in patients with advanced solid tumors. The study consists of a Phase I dose escalation phase to determine the maximum tolerated dose, followed by a Phase II evaluation of efficacy at the recommended dose for GPC3-positive solid tumors. Participants will be closely monitored for treatment responses and side effects throughout the trial.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced solid tumors that are refractory to standard treatments or for whom no standard treatment is available.

Not a fit: Patients with solid tumors that are not GPC3-positive or those who have not exhausted standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that are resistant to standard therapies.

How similar studies have performed: Other studies have shown promise with similar approaches targeting advanced solid tumors, but the specific efficacy of CM350 remains to be established.

Eligibility criteria

Inclusion Criteria:

* Patient with histologically or cytologically confirmed advanced solid tumors that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
* hepatocellular-cancer(HCC) participants must have a Barcelona Clinic Liver Cancer (BCLC) stage of B (ineligible for liver surgery and/or other locoregional treatments, or disease progression after locoregional therapy) or stage C , or a China National Liver Cancer (CNLC) stage of IIb or III (ineligible for liver surgery and/or other locoregional treatments, or disease progression after locoregional therapy).
* HCC participants must have a Child-Pugh score of ≤7.
* Phase I dose escalation phase: participants must have evaluable lesions based on RECIST version 1.1.Phase I dose expansion phase and phase II: participants must have at least one measurable lesion.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

* Patients who have received any cytotoxic chemotherapy, radiotherapy, biological therapy (oncologic vaccines, cytokines, or growth factors for cancer control), or any other investigational anticancer drug treatment (defined as treatments without regulatory approval for any indication) within 28 days before the first dose of CM350.

Note: For palliative radiotherapy to non-central nervous system lesions (total radiotherapy duration ≤14 days) to improve symptoms, a minimum washout period of 7 days before the first dose is required.

* Patients who have received any immunotherapy (including but not limited to PD-1, PD-L1, anti-cytotoxic T-lymphocyte-associated antigen 4 \[CTLA-4\], chimeric antigen receptor T-cell \[CAR-T\] therapy, etc.) within 28 days or 5 half-lives (whichever is shorter) before the first dose of CM350.
* Patients who have received targeted therapy within 28 days or 5 half-lives (whichever is shorter) before the first dose of CM350.
* Patients who have previously received any therapy targeting GPC3, including but not limited to monoclonal antibodies, peptide vaccines, CAR-T, and bispecific antibodies.
* Received chronic systemic corticosteroid therapy (daily intake of more than 10 mg prednisone or equivalent doses of other corticosteroids) or any other form of immunosuppressive treatment within 7 days before the first dose of CM350.
* Known active central nervous system metastases. Note: Participants with previously treated brain metastases that have been stable for at least 14 days before the first dose (confirmed by repeat imaging at least 4 weeks apart, with the repeat imaging conducted during the screening period) may be considered for enrollment.
* Participants with uncontrolled pleural effusion, ascites, or pericardial effusion as assessed by the investigator.
* History of other malignancies within 5 years before the first dose of CM350, excluding cured basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, or ductal carcinoma in situ of the breast.
* Presence of active infection at screening as assessed by the investigator.

Where this trial is running

Chengdu, Sichuan and 1 other locations

• West China Hospital of Sichuan University — Chengdu, Sichuan, China (RECRUITING)
• Zhongshan Hospital Affiliated to Fudan University — Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: Jia Fan — Shanghai Zhongshan Hospital
• Study coordinator: Qian Jia

Conditions: Advanced Solid Tumor