Actively Recruiting
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
Led by Genfleet Therapeutics (Shanghai) Inc. · Updated on 2025-06-05
36
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes GFS202A in patients with advanced solid tumors who have pre-cachexia or cachexia. This phase I, open-label, multi-center study aims to find the highest safe dose and recommend a dosing range for future research. Participants have cancer-related weight loss and related appetite issues, making this study important for understanding potential treatments in this condition. Participants will receive GFS202A through intravenous infusion every three weeks in a 21-day cycle, for a total treatment duration of 12 weeks. The study includes multiple dose levels of GFS202A to assess safety and tolerability. During the treatment period, participants will be closely monitored for any side effects and pharmacokinetic responses. Throughout the study, participants will undergo various assessments including safety evaluations, collection of blood samples to measure drug levels and immune response, and biomarker analysis related to cachexia. Researchers will also monitor weight changes, muscle mass, and quality of life scores up to six weeks after the last dose. The trial includes follow-up for adverse events and dose-limiting toxicities to ensure participant safety over the study period.
CONDITIONS
Brief 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 agree to participate and sign informed consent
- Men or women aged 18 to 80 years at consent
- Histologically or cytologically confirmed solid tumors
- Pre-cachectic or cachectic with weight loss or baseline BMI less than 21 kg/m2 within 6 months before first dose
- Persistent appetite or eating problems related to cancer
- Adequate organ function
- ECOG performance status score of 0 to 2
- Expected survival time of 3 months or longer as judged by investigator
You will not qualify if you...
- Active brain metastases
- Other active diseases severely affecting digestion or food intake
- Baseline BMI greater than 28 kg/m2
- Infectious diseases
- Clinically significant cardiovascular disease
- Uncontrolled metabolic diseases
- Known significant allergic reactions to antibodies or excipients
- History of drug or alcohol abuse
- Pregnant, lactating, or planning pregnancy during study
- Pleural, peritoneal, or pericardial effusion causing symptoms or needing frequent drainage (1 or more times per month)
- Use of investigational drug within 28 days before first dose or within five half-lives of the drug, whichever is shorter, or planned use during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive GFS202A by intravenous injection every 3 weeks in 21-day cycles.
4 visits (in-person) approximately every 3 weeks
Duration - Up to 6 weeks
Participants are monitored for safety and pharmacokinetics up to 6 weeks after the last dose.
Approximately 2 visits (in-person)
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
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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