At a glance
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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
In Brief
A Phase 1 clinical trial evaluating GFS202A injection for Cancer Cachexia. Currently recruiting, targeting 36 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Participants will receive GFS202A intravenously every 3 weeks (Q3W) in a 21-day cycle. The treatment duration was 12 weeks.