Multiple Myeloma
Conditions
Brief summary
This is a multi-center, open-label, Phase 1/2 study in China to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics and immunogenicity of CM336 in patients with relapsed or refractory multiple myeloma. This study consists of a dose escalation part (Phase 1) and a dose extension part (Phase 2 ). The safety and tolerability of CM336 will be evaluated in Phase 1 study, as well as the maximum tolerated dose (MTD) and the recommended dose level for Phase 2 study will be determined. The efficacy of CM336 will be evaluated in Phase 2 study.
Interventions
DRUGCM336_group 1
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 0.04mg of CM336 on the first day of first cycle (C1D1), 0.04mg on C1D8, 0.04mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUGCM336_group 2a
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 0.04mg of CM336 on the first day of first cycle (C1D1), 0.2mg on C1D8, 1.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUGCM336_group 2b
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 0.2mg of CM336 on the first day of first cycle (C1D1), 0.2mg on C1D8, 0.2mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUGCM336_group 3a
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 0.2mg of CM336 on the first day of first cycle (C1D1), 1.0mg on C1D8, 5.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUGCM336_group 3b
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 1.0mg of CM336 on the first day of first cycle (C1D1), 1.0mg on C1D8, 1.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUGCM336_group 4a
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 1.0mg of CM336 on the first day of first cycle (C1D1), 5.0mg on C1D8, 15.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUGCM336_group 4b
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 2.0mg of CM336 on the first day of first cycle (C1D1), 2.0mg on C1D8, 2.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUGCM336_group 5
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 2.0mg of CM336 on the first day of first cycle (C1D1), 8.0mg on C1D8, 24.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUGCM336_group 6a
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 2.0mg of CM336 on the first day of first cycle (C1D1), 10.0mg on C1D8, 40.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUGCM336_group 6b
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 3.0mg of CM336 on the first day of first cycle (C1D1), 3.0mg on C1D8, 3.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUGCM336_group 7
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 3.0mg of CM336 on the first day of first cycle (C1D1), 15.0mg on C1D8, 60.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUGCM336_group 8a
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 3.0mg of CM336 on the first day of first cycle (C1D1), 15.0mg on C1D8, 75.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUGCM336_group 8b
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 4.0mg of CM336 on the first day of first cycle (C1D1), 4.0mg on C1D8, 4.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUGCM336_group 9
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 4.0mg of CM336 on the first day of first cycle (C1D1), 20.0mg on C1D8, 90.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUGCM336_RP2D
CM336 will be administered subcutaneously (SC) once a week (QW). Individual subjects may continue study treatment until disease progression/relapse, unacceptable toxicity, withdrawal of consent, receipt of other anti-MM therapies, death, loss to follow-up, or the end of study.
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2. * Patients with relapsed or refractory MM who have failed or are intolerant to all therapies with known clinical benefit; patients must have received at least 2 prior anti-myeloma therapies which must contain at least one proteasome inhibitor (PI), one immunomodulatory drug (IMiD), and one anti-CD38 monoclonal antibody (if available).
Exclusion criteria
* Patients who had received BCMA-targeted therapy. * Patients who had received CAR-T therapy. * Patients who had received anti-tumor therapy within 3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of CM336.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicities (DLTs) | 21 days after the first dose | Dose-limiting toxicities (DLTs) |
| Adverse events (AEs) | Up to 4.5 years | Adverse events (AEs), including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing. |
| Overall Response Rate (ORR) | up to 4.5 years | Assessed according to International Myeloma Working Group (IMWG) response criteria. |
Countries
China
Contacts
Primary ContactQian Jia
Outcome results
None listed