A Phase I Clinical Study to Evaluate the Efficacy and Safety of GB18 Injection in Patients With Tumor Cachexia

Summary

KXZY-GB18-101(1B) is an extension of KXZY-GB18-101, a first-in-human, dose-escalation trial in healthy adult participants to evaluate the safety, tolerability, PK, PD, and immunogenicity of GB18. As a humanized GDF15 monoclonal antibody, GB18 is expected to improve anorexia and weight loss caused by metabolic disorders driven by overactivation of the GDF15-GFRAL-RET signaling pathways. With favorable readouts of KXZY-GB18-101, this study aims to evaluate the effects of GB18 in patients with tumor cachexia. This open-label, multiple-ascending-dosing study will enroll 18-36 participants into 3 dosing-level cohorts (B1-B3, each with 6-12 participants).

Timeline

Start

2026-06-10

Primary completion

2027-09-30

Completion

2027-12-30

Drugs

Indications