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Recruiting NCT06898255

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

Phase I Interventional Cancer Cachexia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GFS202A injection.
Who it may be relevant to
Registry conditions: Cancer Cachexia. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug GFS202A injection
    Participants will receive GFS202A intravenously every 3 weeks (Q3W) in a 21-day cycle. The treatment duration was 12 weeks.

Primary outcome measures

  • Incidence 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]
Secondary outcome measures (10)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.
  • It has adequate organ function.
  • The ECOG PS score was 0-2.
  • The investigator judged the expected survival time to be ≥ 3 months.

Exclusion criteria

  • 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.
  • With clinically significant cardiovascular disease.
  • With uncontrolled metabolic diseases.
  • With known clinically significant allergic reactions to antibodies and excipients.
  • With history of drug or alcohol abuse.
  • Pregnant or lactating female subjects or women planning to become pregnant during the study.
  • With pleural, peritoneal, or pericardial effusion that causes overt symptoms or requires repeated drainage (frequency ≥ 1 time/month).
  • Use of any investigational drug within 28 days before the first study dose or within five half-lives of the drug, whichever was shorter, or planned for the duration of the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun-Yat Sen university cancer center — Guangzhou

Identifiers

NCT: NCT06898255 · GFS202AX1101 · CXSL2400937

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗