Clinical trialPhase 1Recruiting
A Phase I Clinical Study to Evaluate the 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
- Outcome
- Ongoing
- Phase
- Phase 1
- Status
- Recruiting
- Study type
- Interventional
- Start
- 10 June 2026
- Expected end
- 30 December 2027
- Enrollment
- 18 participants
- Sites
- 2
- Primary outcomes
- Incidence of adverse events
- Sponsor
- Industry
- Results posted
- No
- Last update
- 12 June 2026
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.