Status:
RECRUITING
A Phase I Study to Evaluate GFS202A in Advanced Solid Tumor Patients With Pre-cachexia or Cachexia
Lead Sponsor:
Genfleet Therapeutics (Shanghai) Inc.
Conditions:
Cancer Cachexia
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 6 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06898255
Start Date
April 24 2025
End Date
July 6 2026
Last Update
June 5 2025
Active Locations (1)
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1
Sun-Yat Sen university cancer center
Guangzhou, Guangdong, China, 510000