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

Launched by GENFLEET THERAPEUTICS (SHANGHAI) INC. · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to study a new treatment called GFS202A for patients with advanced solid tumors who are experiencing pre-cachexia or cachexia, which are conditions characterized by significant weight loss and reduced appetite due to cancer. The main goal of the study is to find out if GFS202A is safe to use and to determine the highest dose that patients can tolerate. This information will help guide future research on this treatment.

To participate in the trial, patients need to be between 18 and 80 years old, have a confirmed diagnosis of solid tumors, and be experiencing appetite or eating problems related to their cancer. Participants will receive GFS202A and will be closely monitored for safety and any potential effects of the treatment. It’s important to note that certain individuals, such as those with active brain metastases or other significant health issues, may not be eligible to join the study. The trial is not currently recruiting participants, but it aims to gather valuable information about GFS202A that could benefit future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntarily participate in the study and sign the informed consent form.
• • 2. Men or women between the ages of 18 and 80 years at the time of written informed consent.
• • 3. 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.
• • 4. Persistent concomitant appetite/eating problems related to cancer.
• • 5. It has adequate organ function.
• • 6. The ECOG PS score was 0-2.
• • 7. The investigator judged the expected survival time to be ≥ 3 months.
• Exclusion Criteria:
• • 1. With active brain metastases.
• • 2. With other active diseases that lead to reduced food intake or seriously affect digestion and absorption
• • 3. Baseline BMI \> 28 kg/m2.
• • 4. With infectious diseases.
• • 5. With clinically significant cardiovascular disease.
• • 6. With uncontrolled metabolic diseases.
• • 7. With known clinically significant allergic reactions to antibodies and excipients.
• • 8. With history of drug or alcohol abuse.
• • 9. Pregnant or lactating female subjects or women planning to become pregnant during the study.
• • 10. With pleural, peritoneal, or pericardial effusion that causes overt symptoms or requires repeated drainage (frequency ≥ 1 time/month).
• • 11. 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.