NCT06868849

A Study of JMT203 in Patients With Cancer Cachexia

An Open-label, Multi-center, Phase I Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of JMT203 in Patients With Cancer Cachexia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Shanghai JMT-Bio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter Phase I clinical study aimed at evaluating the safety/tolerability, pharmacokinetics, and effectiveness of JMT203 in patients with cancer cachexia.

Detailed description

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 Ib, which is a cohort-expansion study of JMT203 in the same patient population. 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 Ib, the primary objectives include evaluating the preliminary efficacy of JMT203 in treating cancer cachexia and determining the recommended Phase 2 dose (RP2D) of JMT203.

Conditions

• Colorectal Cancer
• Non Small Cell Lung Cancer
• Pancreatic Cancer
• Cancer Cachexia

Interventions

Type	Name	Description
DRUG	JMT203 Injection	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).

Timeline

• Start date: 2024-05-15
• Primary completion: 2026-05-01
• Completion: 2028-05-01
• First posted: 2025-03-11
• Last updated: 2025-03-11

Locations

1 site across 1 country: China