Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07519564
PHASE1

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

Sponsor: Kexing Biopharm Co., Ltd.

View on ClinicalTrials.gov

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).

Official title: A Phase I Clinical Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of GB18 Injection in Patients With Tumor Cachexia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2026-04-30

Completion Date

2027-12-30

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

GB18

GB18 will be administered via subcutaneous injection with different doses.

Locations (2)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Beijing GoBroad Hospital

Beijing, Beijing Municipality, China