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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Participants will receive GFS202A intravenously every 3 weeks (Q3W) in a 21-day cycle. The treatment duration was 12 weeks.
Sun-Yat Sen university cancer center
Guangzhou, Guangdong, China
RECRUITINGIncidence of AE/SAE
Time frame: Up to 6 weeks after the last dose
Incidence of DLT
Time frame: Up to 21 days after the first dose
Peak Plasma Concentration (Cmax)
Time frame: Baseline, up to 6 weeks after the last dose
Area under the plasma concentration versus time curve (AUC)
Time frame: Baseline, up to 6 weeks after the last dose
Trough Plasma Concentration (Ctrough)
Time frame: Baseline, up to 6 weeks after the last dose
Half-life (T1/2)
Time frame: Baseline, up to 6 weeks after the last dose
Incidence of ADA
Time frame: Baseline, up to 6 weeks after the last dose
Concentration of GDF-15 and IL-6
Time frame: Baseline, up to 6 weeks after the last dose
Weight change from baseline
Time frame: Baseline, up to 6 weeks after the last dose
L3SMI change from baseline
Time frame: Baseline, up to 6 weeks after the last dose
Change from baseline in Functional Assessment of Anorexia-Cachexia Therapy (FAACT-ACS) scores
Time frame: Baseline, up to 6 weeks after the last dose
Change from baseline in Functional Assessment of Cancer Therapy-General (FACT-G) scores
Time frame: Baseline, up to 6 weeks after the last dose
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