Phase IaII Multicenter Study Evaluating JMT203 Injection for Treating Cancer Cachexia in Adults with Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and efficacy of JMT203 in patients with cancer cachexia, a condition characterized by severe weight loss in people with cancer. This study includes two parts Phase Ia, focusing on dose escalation and expansion to find safe and effective doses, and Phase II, a randomized, double-blind, placebo-controlled trial involving patients with colorectal cancer cachexia, pancreatic cancer cachexia, or cachexia from other solid tumors. The study aims to determine the recommended dose for future studies and assess preliminary treatment effects over 12 weeks. During Phase Ia, JMT203 will be tested in increasing doses using an accelerated titration design with a 33 dose escalation scheme. Dose expansion will select 1 to 3 potentially effective doses based on safety and pharmacokinetic data. In Phase II, participants will be randomly assigned to receive either JMT203 at 50 mg or 150 mg, or a placebo, administered as subcutaneous injections every three weeks for 12 weeks. An open-label extension phase may continue treatment at 150 mg or the recommended Phase 3 dose for up to 51 weeks. Participants will undergo regular assessments including monitoring adverse events, dose-limiting toxicities, and changes in body weight and muscle mass. Imaging by computed tomography and questionnaires about anorexia severity will be used to evaluate effects. Pharmacokinetic measurements and antibody responses will be tracked up to 90 days after dosing. The study also monitors survival and progression-free survival up to three years. Participants can expect visits for treatment administration, safety checks, and evaluation of their cancer cachexia symptoms throughout the study period.

A Study of JMT203 in Patients With Cancer Cachexia