A Study of CM350 in Patients With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05263960
• Other study ID #: CM350-030001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 21, 2022
• Est. completion date: March 2025

Study information

• Verified date: February 2022
• Source: Keymed Biosciences Co.Ltd
• Contact: Qian Jia
• Phone: +862888610620
• Email: qianjia[@]keymedbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The phase I study consists of a dose escalation part (Part A) and a dose extension part (Part B). The safety and tolerability of CM350 and the maximum tolerated dose (MTD) will be evaluated in Part A. The safety, tolerability and efficacy of CM350 at MTD and/or the dose of one level less than MTD (MTD-1), and the recommended dose level for the phase II study will be determined in Part B.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Dose escalation part of Phase I study : Patient with histologically or cytologically confirmed advanced solid tumors for which standard treatment do not exist, are no longer effective, or are not acceptable to the patient.
• Dose expansion part of Phase I study : Patient with histologically or cytologically confirmed IHC GPC3-positive advanced solid tumors for which standard treatment do not exist, are no longer effective, or are not acceptable to the patient.

Exclusion Criteria:

• Patients who received any cytotoxic chemotherapy agent, radiotherapy, targeted therapy, biotherapy, antitumor traditional Chinese medicine, or any other investigational antitumor agent within 28 days prior to first dosing of CM350.
• Had major surgery within 28 days prior to first dosing of CM350.
• Received any antibodies/drugs/therapies targeting T-cell co-regulatory proteins (immune checkpoints) within 28 days or 5 half-lives (whichever is shorter) prior to first dosing of CM350, including but not limited to cytokine therapy, anti-programmed death receptor 1 (PD-1), anti-programmed death receptor ligand-1 (PD-L1), anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), chimeric antigen receptor T cell (CAR T) therapy, etc.
• Received therapies targeting GPC3, including but not limited to monoclonal antibodies, peptide vaccines, chimeric antigen receptor T cells (CAR-T), and bispecific antibodies.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• CM350_group 1
CM350 will be administered intravenously (IV) once a week (QW). Patients will take 5ug of CM350 on the first day of first cycle (C1D1), 5ug on C1D8, 5ug on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
• CM350_group 2
CM350 will be administered intravenously (IV) once a week (QW). Patients will take 15ug of CM350 on the first day of first cycle (C1D1), 15ug on C1D8, 15ug on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
• CM350_group 3
CM350 will be administered intravenously (IV) once a week (QW). Patients will take 45ug of CM350 on the first day of first cycle (C1D1), 45ug on C1D8, 45ug on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
• CM350_group 4
CM350 will be administered intravenously (IV) once a week (QW). Patients will take 45ug of CM350 on the first day of first cycle (C1D1), 135ug on C1D8, 135ug on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
• CM350_group 5a
CM350 will be administered intravenously (IV) once a week (QW). Patients will take 45ug of CM350 on the first day of first cycle (C1D1), 135ug on C1D8, 270ug on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
• CM350_group 5b
CM350 will be administered intravenously (IV) once a week (QW). Patients will take 135ug of CM350 on the first day of first cycle (C1D1), 135ug on C1D8, 135ug on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
• CM350_group 6a
CM350 will be administered intravenously (IV) once a week (QW). Patients will take 45ug of CM350 on the first day of first cycle (C1D1), 135ug on C1D8, 405ug on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
• CM350_group 6b
CM350 will be administered intravenously (IV) once a week (QW). Patients will take 135ug of CM350 on the first day of first cycle (C1D1), 270ug on C1D8, 270ug on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
• CM350_group 7
CM350 will be administered intravenously (IV) once a week (QW). Patients will take 135ug of CM350 on the first day of first cycle (C1D1), 405ug on C1D8, 405ug on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
• CM350_group 8
CM350 will be administered intravenously (IV) once a week (QW). Patients will take 405ug of CM350 on the first day of first cycle (C1D1), 405ug on C1D8, 405ug on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
• CM350_MTD level
CM350 will be administered intravenously (IV) once a week (QW). Individual subjects may continue study treatment until there is evidence of disease progression (clinical or radiologic) judged by Investigators, unacceptable toxicity or other reasons for treatment discontinuation.
• CM350_MTD-1 level
CM350 will be administered intravenously (IV) once a week (QW). Individual subjects may continue study treatment until there is evidence of disease progression (clinical or radiologic) judged by Investigators, unacceptable toxicity or other reasons for treatment discontinuation.

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Keymed Biosciences Co.Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose escalation part and dose expansion part : Incidence of Adverse events(AEs), including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.	Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.	Up to 3 years
Primary	Dose escalation part: Dose-Limiting Toxicity (DLT)	Dose-Limiting Toxicity (DLT)	Up to 21 days after the first dose
Primary	Dose escalation part: maximum tolerated dose (MTD)	Maximum tolerated dose (MTD)	Up to the end of dose escalation part (1 year)
Primary	Dose expansion part: recommended phase II dose (RP2D)	Recommended phase II dose (RP2D)	Up to the end of dose expansion part (2 years)
Secondary	Proportion of subjects with positive anti-drug antibody (ADA) and neutralizing antibody (Nab)	Proportion of subjects with positive anti-drug antibody (ADA) and neutralizing antibody (Nab)	Up to 3 years
Secondary	Overall Survival (OS)	Overall Survival (OS)	Up to 3 years
Secondary	Overall Response Rate (ORR), assessed according to RECIST v1.1	Overall Response Rate (ORR), assessed according to RECIST v1.1	Up to 3 years
Secondary	Duration of Response (DOR), assessed according to RECIST v1.1	Duration of Response (DOR), assessed according to RECIST v1.1	Up to 3 years
Secondary	Disease Control Rate (DCR), assessed according to RECIST v1.1	Disease Control Rate (DCR), assessed according to RECIST v1.1	Up to 3 years
Secondary	Progression Free Survival (PFS), assessed according to RECIST v1.1	Progression Free Survival (PFS), assessed according to RECIST v1.1	Up to 3 years
Secondary	Time to progression (TTP), assessed according to RECIST v1.1	Time to progression (TTP), assessed according to RECIST v1.1	Up to 3 years