Advanced Solid TumorPhase 1/2NCT05263960
A Study of CM350 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing CM350 group1, CM350 group2 and CM350 group3 in people with Advanced Solid Tumor, run by Keymed Biosciences Co.Ltd at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- CM350 group1, CM350 group2 and CM350 group3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 2 sitesChina
- Study dates
- 21 Apr 2022to Apr 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Yongsheng Wang
- Recruiting
Zhongshan Hospital Affiliated to Fudan University
Shanghai
Jia Fan
About this study
Official title: A Multicenter, Open Label, Phase I/II Clinical Study of CM350 in Patients With Advanced Solid Tumors
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
- Advanced Solid Tumor
- Being tested
- CM350 group1, CM350 group2, CM350 group3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM350 group1Biological
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).
CM350 group2Biological
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).
CM350 group3Biological
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).
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation phase in phase I | Experimental | There are 11 target dose levels in dose escalation phase. Receives: Biological: CM350 group1 |
| Dose expansion phase in phase I | Experimental | Three or four doses will be selected for further evaluation in dose expansion phase to determine the RP2D (recommended phase 2 dose). Receives: Biological: CM350 group2 |
| Phase II | Experimental | The efficacy of CM350 will be evaluated at RP2D (recommended phase 2 dose) for advanced GPC3-positive solid tumors. Receives: Biological: CM350 group3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years
Dose escalation phase in phase I:Dose-Limiting Toxicity (DLT).
Dose-Limiting Toxicity (DLT).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to 5 years
Secondary outcomes (22)
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
Measured: 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)
Measured: 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]
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: Up to 5 years
Phase I & Phase II:To evaluate the overall survival (OS)
To evaluate the overall survival (OS)
Measured: Up to 5 years
Phase I & Phase II:To assess the cytokine interleukin-2 (IL-2).
To assess the pharmacokinetic (PD) profile of CM350.
Measured: 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.
Measured: 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).
Measured: Up to 5 years
Phase I & Phase II:Peak Plasma Concentration (Cmax).
Peak Plasma Concentration (Cmax)
Measured: Up to 5 years
Phase I & Phase II:Time of Maximum Observed Concentration (Tmax).
Time of Maximum Observed Concentration (Tmax)
Measured: 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)
Measured: Up to 5 years
Phase I & Phase II:To assess the cytokine interleukin-6 (IL-6).
To assess the cytokine interleukin-6 (IL-6)
Measured: Up to 5 years
Phase I & Phase II:To assess the cytokine interleukin-10 (IL-10).
To assess the cytokine interleukin-10 (IL-10)
Measured: Up to 5 years
Phase I & Phase II:To assess the cytokine interferon-gamma(IFN-γ).
To assess the cytokine interferon-gamma(IFN-γ)
Measured: 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)
Measured: 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+).
Measured: 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+).
Measured: 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+).
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start21 Apr 2022
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Keymed Biosciences Co.LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jia Fan, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263960
- Sponsor's protocol ID
- CM350-030001
- Status last verified
- Apr 2025
- First submitted
- 10 Feb 2022
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 40307410
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label, Phase I/II Clinical Study of CM350 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05263960
- Acronym / sponsor ID
- CM350-030001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose escalation phase in phase I | Experimental | Biological: CM350 group1There are 11 target dose levels in dose escalation phase. |
| Dose expansion phase in phase I | Experimental | Biological: CM350 group2Three or four doses will be selected for further evaluation in dose expansion phase to determine the RP2D (recommended phase 2 dose). |
| Phase II | Experimental | Biological: CM350 group3The efficacy of CM350 will be evaluated at RP2D (recommended phase 2 dose) for advanced GPC3-positive solid tumors. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM350 group1CM350 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). | Biological | Dose escalation phase in phase I |
| CM350 group2CM350 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). | Biological | Dose expansion phase in phase I |
| CM350 group3CM350 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). | Biological | Phase II |
Primary outcome
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.
Time frame: Up to 5 years
Incidence of Adverse events（AEs）, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Dose escalation phase in phase I:Dose-Limiting Toxicity (DLT).
Time frame: Up to 7 days after the first target dose
Dose-Limiting Toxicity (DLT).
Dose escalation phase in phase I:Maximum tolerated dose (MTD) (if applicable).
Time frame: Up to the end of dose escalation phase (3 years)
Maximum tolerated dose (MTD) (if applicable).
Dose expansion phase in phase I:To determine the recommended Phase 2 Dose (RP2D).
Time frame: Up to 5 years
the efficacy including objective response rate (ORR), disease control rate (DCR), etc., safety, pharmacokinetics (PK) and pharmacodynamics (PD) profile of CM350 will be assessed.
Phase II:To evaluate the efficacy of CM350 in advanced glypican-3-positive solid tumors.
Time frame: Up to 5 years
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.
22 secondary outcomes
Phase I & Phase II: Area Under the Curve from 0 to the time of the last quantifiable concentration (AUC0-t).
Time frame: Up to 5 years
Phase I & Phase II: 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].
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).
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).
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.
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).
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).
Time frame: Up to 5 years
Phase I & Phase II:To evaluate the overall survival (OS)
Time frame: Up to 5 years
Phase I & Phase II:To assess the cytokine interleukin-2 (IL-2).
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.
Time frame: Up to 5 years
Phase I & Phase II:Area Under the Curve over a dosing interval (AUC tau).
Time frame: Up to 5 years
Phase I & Phase II:Peak Plasma Concentration (Cmax).
Time frame: Up to 5 years
Phase I & Phase II: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).
Time frame: Up to 5 years
Phase I & Phase II: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).
Time frame: Up to 5 years
Phase I & Phase II: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).
Time frame: Up to 5 years
Phase I & Phase II: 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+).
Time frame: Up to 5 years
Phase I & Phase II: To assess the Immunophenotyping cluster of differentiation 8 positive (CD8+).
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Derived from this study: PubMed 40307410Zhou 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.
Related trials for Advanced Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jia Fan principal investigator
Shanghai Zhongshan Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CM350 group1, CM350 group2 and CM350 group3 in people with Advanced Solid Tumor, run by Keymed Biosciences Co.Ltd at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qian Jia (+862888610620, qianjia@keymedbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Up to 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05263960, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.