A Study of CM350 in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKeymed Biosciences Co.Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
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.
Trial design
Design model
Sequential
Treatments tested in this trial
CM350 group1
Biological/VaccineCM350 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 group2
Biological/VaccineCM350 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 group3
Biological/VaccineCM350 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).
Treatment groups
248 Participants
are divided into 3 treatment groupsGroup A: Dose escalation phase in phase IExperimental treatment 1 intervention
Group B: Dose expansion phase in phase IExperimental treatment 1 intervention
Group C: Phase IIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 years2
Dose escalation phase in phase I:Dose-Limiting Toxicity (DLT).
Dose-Limiting Toxicity (DLT).
Time frame
Up to 7 days after the first target dose3
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)4
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 yearsSecondary outcomes
1
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 years2
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 years3
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 years4
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 yearsSponsors and contacts
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Source ClinicalTrials.gov