A Phase Ia/II, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of JMT203 in Patients with Cancer Cachexia
This is a study of JMT203 in patients with cancer cachexia, comprising two parts: Phase Ia, which involves a dose-escalation and dose-expansion study of JMT203 in patients with cancer cachexia, and Phase II, which is a multicenter, randomized, double-blind, placebo-controlled clinical study. The phase II stage includes three cohorts: Cohort A (participants with colorectal cancer cachexia), Cohort B (participants with pancreatic cancer cachexia), and Cohort C (participants with cachexia from other solid tumors) . The primary objectives of Phase Ia are to assess the safety/tolerability of JMT203 in patients with cancer cachexia and to determine the maximum tolerated dose (MTD) (if any) and/or the recommended dose for expansion (RDE) of JMT203. In Phase II, the primary objectives include evaluating the preliminary efficacy of JMT203 at doses of 50 mg and 150 mg versus placebo over a 12-week treatment period and determining the recommended Phase 3 dose (RP3D) of JMT203.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
307
Drug:JMT203 Injection * Anti-GFRAL monoclonal antibody * Will be injected subcutaneously once per cycle (3 weeks, on Day 1) for 12 weeks, or will be injected subcutaneously once per cycle (3 weeks, on Day 1).
Drug:JMT203 Injection * Anti-GFRAL monoclonal antibody * Will be injected subcutaneously once per cycle (3 weeks, on Day 1) for 12 weeks, or will be injected subcutaneously once per cycle (3 weeks, on Day 1).
Sir run run shaw Hospital
Zhejiang, China
RECRUITINGPhase Ia: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Time frame: Up to 90 days after the last dose of JMT203
Phase Ia: Incidence of dose-limiting toxicity (DLT) events
Time frame: Up to 21 days after the first dose of JMT203
Phase Ia: MTD (if applicable).
Time frame: Up to 90 days post last dose
Phase Ia: RDE.
Time frame: Up to 90 days post last dose
Phase Ib: Average change in body weight from baseline at each assessment timepoint within 12 weeks.
Time frame: Within 12 weeks from baseline
Phase II: RP3D
Time frame: Approximately 1 year from baseline
Phase Ia: Area under the curve from time "0" to the time of the last measurable concentration (AUC0-t) of JMT203
Time frame: Up to 90 days after the last dose of JMT203
Phase Ia: Maximum measured plasma concentration (Cmax) of JMT203
Time frame: Up to 90 days after the last dose of JMT203
Phase Ia: Time when Cmax occurred (Tmax) of JMT203
Time frame: Up to 90 days after the last dose of JMT203
Phase Ia: Incidence of anti-drug antibodies (ADA).
Time frame: Up to 90 days after the last dose of JMT203
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Phase Ia: Average change in body weight from baseline at each assessment timepoint within 12 weeks.
Time frame: Within 12 weeks from baseline
Phase II: Average change in the skeletal muscle index (SMI) of the third lumbar vertebra, measured by computed tomography (CT), from baseline to 12 weeks.
Time frame: Within 12 weeks from baseline
Phase II: Average change in the severity of anorexia (based on the Functional Assessment of Anorexia/Cachexia Therapy - Anorexia/Cachexia Subscale [FAACT-A/CS]) from baseline to each assessment timepoint.
Time frame: Within 12 weeks from baseline
Phase II: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Time frame: Up to 90 days after the last dose of JMT203
Phase II: Blood concentration of JMT203;
Time frame: Up to 90 days after the last dose of JMT203
PhaseII: Incidence of ADA.
Time frame: Up to 90 days after the last dose of JMT203
PhaseII: Objective Response Rate (ORR)
Time frame: Approximately 12 weeks from baseline
PhaseII: Progression-Free Survival (PFS)
Time frame: Approximately 1 year from baseline
Phase II: overall survival (OS).
Time frame: Approximately up to 3 years