Actively Recruiting
A Phase I Study to Evaluate GFS202A in Advanced Solid Tumor Patients With Pre-cachexia or Cachexia
Led by Genfleet Therapeutics (Shanghai) Inc. · Updated on 2025-06-05
36
Participants Needed
1
Research Sites
62 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase I Study to Evaluate GFS202A in Advanced Solid Tumor Patients With Pre-cachexia or Cachexia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or eating problems related to cancer.
- Adequate organ function.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2.
- Expected survival time of 3 months or more as judged by the investigator.
You will not qualify if you...
- Presence of active brain metastases.
- Other active diseases that reduce food intake or seriously affect digestion and absorption.
- Baseline BMI greater than 28 kg/m2.
- Presence of infectious diseases.
- Clinically significant cardiovascular disease.
- Uncontrolled metabolic diseases.
- Known clinically significant allergic reactions to antibodies or excipients.
- History of drug or alcohol abuse.
- Pregnant or lactating women or women planning to become pregnant during the study.
- Presence of pleural, peritoneal, or pericardial effusion causing overt symptoms or requiring repeated drainage (once or more per month).
- Use of any investigational drug within 28 days before the first study dose or within five half-lives of the drug, whichever is shorter, or planned use during the study.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun-Yat Sen university cancer center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
Y
Yuting Peng, PM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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