NCT06898255

A Phase I Study to Evaluate GFS202A in Advanced Solid Tumor Patients With Pre-cachexia or Cachexia

An Open-label, Multi-center, Phase I Study to Evaluate the Safety/Tolerability and Pharmacokinetics of GFS202A in Advanced Solid Tumor Patients With Pre-cachexia or Cachexia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Genfleet Therapeutics (Shanghai) Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

An open-label, multi-center, phase I study to evaluate the safety/tolerability and pharmacokinetics of GFS202A in advanced solid tumor patients with pre-cachexia or cachexia. The primary objective is to assess the safety/tolerability of GFS202A, determine its maximum tolerated dose (MTD), and recommend a dose range for future studies. Enroll participants with cancer cachexia or precachexia to receive GFS202A monotherapy. During the study period, participants will undergo assessments for safety and preliminary efficacy according to the visit schedule. Pharmacokinetic, anti-drug antibody (ADA), and pharmacodynamic (PD) /biomarker samples will be collected.

Conditions

• Cancer Cachexia

Interventions

Type	Name	Description
DRUG	GFS202A injection	Participants will receive GFS202A intravenously every 3 weeks (Q3W) in a 21-day cycle. The treatment duration was 12 weeks.

Timeline

• Start date: 2025-04-24
• Primary completion: 2026-06-08
• Completion: 2026-07-06
• First posted: 2025-03-27
• Last updated: 2025-06-05

Locations

1 site across 1 country: China