NCT07519564

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Kexing Biopharm Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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 associated with metabolic disorders by targeting the overactivation of GDF15-GFRAL-RET signaling pathways. With favorable readouts of KXZY-GB18-101, KXZY-GB18-101(1B) aims to evaluate the efficacy and safety of GB18 in patients with tumor cachexia. This open-label, multiple-ascending-dosing study will enroll 18-36 participants into 3 dosing-level cohorts (each with 6-12 participants). The treatment and follow-up period will be 12 weeks each. Each participant will undergo safety and efficacy assessments, including vital sign measurements, physical examinations, 12-lead electrocardiograms, and laboratory tests before and after GB18 administration. Blood samples will also be collected to evaluate pharmacokinetic and pharmacodynamic properties, as well as the immunogenicity. The aims of this study include: * To evaluate the safety and tolerability of GB18 after multiple subcutaneous injections of GB18 in Chinese participants with tumor cachexia. * To evaluate the efficacy of multiple subcutaneous injections of GB18 in Chinese participants with tumor cachexia. * To evaluate the PK characteristics of Chinese tumor cachexia participants after multiple subcutaneous injections of GB18. * To evaluate the PD characteristics of Chinese participants with tumor cachexia after multiple subcutaneous injections of GB18. * To evaluate the immunogenicity of multiple subcutaneous injections of GB18 in Chinese participants with tumor cachexia.

Conditions

• Cachexia; Cancer

Interventions

Type	Name	Description
DRUG	GB18	GB18 will be administered via subcutaneous injection with different doses.

Timeline

• Start date: 2026-04-30
• Primary completion: 2027-09-30
• Completion: 2027-12-30
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study