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A Phase I Study to Evaluate GFS202A in Advanced Solid Tumor Patients With Pre-cachexia or Cachexia
Sponsor: Genfleet Therapeutics (Shanghai) Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2025-04-24
Completion Date
2026-07-06
Last Updated
2025-06-05
Healthy Volunteers
No
Conditions
Interventions
GFS202A injection
Participants will receive GFS202A intravenously every 3 weeks (Q3W) in a 21-day cycle. The treatment duration was 12 weeks.
Locations (1)
Sun-Yat Sen university cancer center
Guangzhou, Guangdong, China