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.
Voluntarily participate in the study and sign the informed consent form.
Men or women between the ages of 18 and 80 years at the time of written informed consent.
Patients with histologically or cytologically confirmed solid tumors. Pre-cachectic and cachectic patients with weight loss or baseline BMI < 21 kg/m2 within 6 months before the first study dose.
Persistent concomitant appetite/eating problems related to cancer.
With active brain metastases.
With other active diseases that lead to reduced food intake or seriously affect digestion and absorption
Baseline BMI > 28 kg/m2.
With infectious diseases.
Sequential
GFS202A injection
DrugParticipants will receive GFS202A intravenously every 3 weeks (Q3W) in a 21-day cycle. The treatment duration was 12 weeks.
6
Treatment groupsSee each treatment group below.
Incidence of AE/SAE
Incidence of DLT
Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)
Trough Plasma Concentration (Ctrough)
Half-life (T1/2)
Click on the lead sponsor to view all of their trials.
