Clinical Trial

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

Recruiting Phase 1
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Record status
This record was last updated June 5, 2025 (before its estimated June 8, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-20.
Status change: Not Yet Recruiting → Recruiting 2025-06-03
Trial Details
NCT Number NCT06898255
Lead Sponsor Genfleet Therapeutics (Shanghai) Inc.
Conditions Cancer Cachexia
Enrollment 36 participants
Start Date 2025-04-24
Primary Completion 2026-06-08 (estimated)
Study Completion 2026-07-06 (estimated)
Updated on ClinicalTrials.gov 2025-06-05