GFS202A for adults with advanced solid tumors and cachexia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, multi-center Phase I dose-escalation trial of GFS202A given as monotherapy to patients with advanced solid tumors and signs of pre-cachexia or cachexia. The primary focus is safety and tolerability, with determination of the maximum tolerated dose and a recommended dose range for future studies. Participants will undergo scheduled safety and preliminary efficacy assessments while pharmacokinetic, anti-drug antibody, and pharmacodynamic/biomarker samples are collected. Eligibility requires adequate organ function, ECOG 0–2, and expected survival of at least three months.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun-Yat Sen university cancer center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Li Zhang, MD — Sun Yat-Sen University Cancer Center
• Study coordinator: Yuting Peng, PM
• Email: ytpeng@genfleet.com
• Phone: 86+13730813620

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.