RecruitingNCT05263960Updated May 4, 2025

A Study of CM350 in Patients With Advanced Solid Tumors

A Phase 1/2 interventional study of CM350 group1 and CM350 group2 in Advanced Solid Tumor, sponsored by Keymed Biosciences Co.Ltd. Recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-04.

Sponsored by Keymed Biosciences Co.Ltd · Phase 1/2, Interventional, and Treatment

From the registry’s dates

Started Apr 2022; still recruiting 4 years 5 months later.

Phase: Phase 1/2
Study type: Interventional
Enrollment: 248
Allocation: Non-randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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.

Conditions studied

Advanced Solid Tumor

Browse trials for

Neoplasms 9,365

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 248 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Keymed Biosciences Co.Ltd is the lead sponsor of 63 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 248 participants (estimated)

Study arms

Experimental
Dose escalation phase in phase I
There are 11 target dose levels in dose escalation phase.
Biological: CM350 group1
Experimental
Dose expansion phase in phase I
Three or four doses will be selected for further evaluation in dose expansion phase to determine the RP2D (recommended phase 2 dose).
Biological: CM350 group2
Experimental
Phase II
The efficacy of CM350 will be evaluated at RP2D (recommended phase 2 dose) for advanced GPC3-positive solid tumors.
Biological: CM350 group3

Interventions

BiologicalCM350 group1
CM350 will be administered intravenously (IV) once a week (QW) through step-up dosing until the participant discontinues study treatment, develops disease progression, initiates a new anti-tumor therapy, develops unacceptable toxicity, death, lost to follow-up, the investigator discontinue study treatment, or a female participant becomes pregnant (whichever occurs first).
BiologicalCM350 group2
CM350 will be administered intravenously (IV) once a week (QW) through step-up dosing until the participant discontinues study treatment, develops disease progression, initiates a new anti-tumor therapy, develops unacceptable toxicity, death, lost to follow-up, the investigator discontinue study treatment, or a female participant becomes pregnant (whichever occurs first).
BiologicalCM350 group3
CM350 will be administered intravenously (IV) once a week (QW). Individual subjects may continue study treatment until the participant discontinues study treatment, develops disease progression, initiates a new anti-tumor therapy, develops unacceptable toxicity, death, lost to follow-up, the investigator discontinue study treatment, or a female participant becomes pregnant (whichever occurs first).

What researchers measure

Primary outcomes

Dose escalation phase in phase I:Incidence of Adverse events（AEs）, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Incidence of Adverse events（AEs）, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Time frame: Up to 5 years
Dose escalation phase in phase I:Dose-Limiting Toxicity (DLT).
Dose-Limiting Toxicity (DLT).
Time frame: Up to 7 days after the first target dose
Dose escalation phase in phase I:Maximum tolerated dose (MTD) (if applicable).
Maximum tolerated dose (MTD) (if applicable).
Time frame: Up to the end of dose escalation phase (3 years)
Dose expansion phase in phase I:To determine the recommended Phase 2 Dose (RP2D).
the efficacy including objective response rate (ORR), disease control rate (DCR), etc., safety, pharmacokinetics (PK) and pharmacodynamics (PD) profile of CM350 will be assessed.
Time frame: Up to 5 years
Phase II:To evaluate the efficacy of CM350 in advanced glypican-3-positive solid tumors.
including objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Modified Response Evaluation Criteria in Solid Tumors \[mRECIST\] for liver cancer and RECIST v1.1) evaluated by investigator.
Time frame: Up to 5 years

Secondary outcomes

Phase I & Phase II: Area Under the Curve from 0 to the time of the last quantifiable concentration (AUC0-t).
After first and multiple dosing
Time frame: Up to 5 years
Phase I & Phase II: To assess the incidence of anti-drug antibody (ADA).
To assess the incidence of anti-drug antibody (ADA)
Time frame: Up to 5 years
Phase I: To evaluate the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [Modified Response Evaluation Criteria in Solid Tumors (mRECIST) for liver cancer and RECIST v1.1].
To evaluate the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 \[Modified Response Evaluation Criteria in Solid Tumors (mRECIST) for liver cancer and RECIST v1.1\]
Time frame: Up to 5 years
Phase I & Phase II: To evaluate the duration of response (DOR) per RECIST v1.1(mRECIST for liver cancer and RECIST v1.1).
To evaluate the duration of response (DOR) per RECIST v1.1(mRECIST for liver cancer and RECIST v1.1)
Time frame: Up to 5 years
Phase I & Phase II: To evaluate the disease control rate (DCR) per RECIST v1.1(mRECIST for liver cancer and RECIST v1.1).
To evaluate the disease control rate (DCR) per RECIST v1.1(mRECIST for liver cancer and RECIST v1.1)
Time frame: Up to 5 years
Phase I & Phase II:To evaluate the time to response (TTR) per RECIST v1.1(mRECIST for liver cancer and RECIST v1.1.
To evaluate the time to response (TTR) per RECIST v1.1(mRECIST for liver cancer and RECIST v1.1
Time frame: Up to 5 years
Phase I & Phase II:To evaluate the time to progression (TTP) per RECIST v1.1(mRECIST for liver cancer and RECIST v1.1).
To evaluate the time to progression (TTP) per RECIST v1.1(mRECIST for liver cancer and RECIST v1.1)
Time frame: Up to 5 years
Phase I & Phase II:To evaluate the progression-free survival (PFS) per RECIST v1.1(mRECIST for liver cancer and RECIST v1.1).
To evaluate the progression-free survival (PFS) per RECIST v1.1(mRECIST for liver cancer and RECIST v1.1)
Time frame: Up to 5 years
Phase I & Phase II:To evaluate the overall survival (OS)
To evaluate the overall survival (OS)
Time frame: Up to 5 years
Phase I & Phase II:To assess the cytokine interleukin-2 (IL-2).
To assess the pharmacokinetic (PD) profile of CM350.
Time frame: Up to 5 years
Phase II:Incidence of Adverse events（AEs）, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Incidence of Adverse events（AEs）, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Time frame: Up to 5 years
Phase I & Phase II:Area Under the Curve over a dosing interval (AUC tau).
Area Under the Curve over a dosing interval (AUC tau).
Time frame: Up to 5 years
Phase I & Phase II:Peak Plasma Concentration (Cmax).
Peak Plasma Concentration (Cmax)
Time frame: Up to 5 years
Phase I & Phase II:Time of Maximum Observed Concentration (Tmax).
Time of Maximum Observed Concentration (Tmax)
Time frame: Up to 5 years
Phase I & Phase II:Observed concentration at the end of a dosing interval (Ctrough).
Observed concentration at the end of a dosing interval (Ctrough)
Time frame: Up to 5 years
Phase I & Phase II:To assess the cytokine interleukin-6 (IL-6).
To assess the cytokine interleukin-6 (IL-6)
Time frame: Up to 5 years
Phase I & Phase II:To assess the cytokine interleukin-10 (IL-10).
To assess the cytokine interleukin-10 (IL-10)
Time frame: Up to 5 years
Phase I & Phase II:To assess the cytokine interferon-gamma(IFN-γ).
To assess the cytokine interferon-gamma(IFN-γ)
Time frame: Up to 5 years
Phase I & Phase II:To assess the cytokine tumor necrosis factor-alpha (TNF-α).
To assess the cytokine tumor necrosis factor-alpha (TNF-α)
Time frame: Up to 5 years
Phase I & Phase II: To assess the Immunophenotyping cluster of differentiation 3 positive (CD3+).
To assess the Immunophenotyping cluster of differentiation 3 positive (CD3+).
Time frame: Up to 5 years
Phase I & Phase II: To assess the Immunophenotyping cluster of differentiation 4 positive (CD4+).
To assess the Immunophenotyping cluster of differentiation 4 positive (CD4+).
Time frame: Up to 5 years
Phase I & Phase II: To assess the Immunophenotyping cluster of differentiation 8 positive (CD8+).
To assess the Immunophenotyping cluster of differentiation 8 positive (CD8+).
Time frame: Up to 5 years

Study locations

2 of 2 sites recruiting

West China Hospital of Sichuan University
Chengdu, Sichuan, China
- Yongsheng Wang · Contact
Recruiting
Zhongshan Hospital Affiliated to Fudan University
Shanghai, China
- Jia Fan · Contact
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05263960
Lead sponsor: Keymed Biosciences Co.Ltd
Responsible party: Sponsor
First posted: Mar 3, 2022
Start date: Apr 21, 2022
Primary completion: Apr 2027 (estimated)
Completion: Apr 2027 (estimated)
Last update: May 4, 2025

Study contacts

Qian Jia

Contact

qianjia@keymedbio.com

+862888610620

Jia Fan

principal investigator · Shanghai Zhongshan Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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