A Phase I Clinical Study to Evaluate the Efficacy and Safety of GB18 Injection in Patients With Tumor Cachexia
Recruiting now · Phase 1
Conditions studied: Cachexia; Cancer
In brief
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).
Key facts
- Study ID
- NCT07519564
- Run by
- Kexing Biopharm Co., Ltd.
- People needed
- 18
- Starts
- 2026-06-10
- Expected to finish
- 2027-12-30
- Last updated by the study team
- 2026-06-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Peking University Cancer Hospital — Beijing, Beijing Municipality, China (enrolling)
- Beijing GoBroad Hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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