GFS202A for adults with advanced solid tumors and cachexia

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

This study will test whether GFS202A is safe and tolerable in adults with advanced solid tumors who have pre-cachexia or cachexia.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Genfleet Therapeutics (Shanghai) Inc. (industry)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06898255 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–80 with histologically confirmed advanced solid tumors and evidence of pre-cachexia or cachexia (recent weight loss or BMI <21 kg/m2), ECOG 0–2, adequate organ function, and expected survival ≥3 months.

Not a fit: Patients with active brain metastases, significant cardiovascular or infectious disease, uncontrolled metabolic disorders, BMI >28 kg/m2, or known severe allergic reactions to antibodies are unlikely to be eligible or benefit.

Why it matters

Potential benefit: If successful, GFS202A could help reduce cancer-related weight loss and improve appetite and physical function in patients with pre-cachexia or cachexia.

How similar studies have performed: Targeting the GDF-15 pathway has shown promising preclinical effects on appetite and weight and limited early clinical signals, but robust human efficacy data are still lacking.

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.

Where this trial is running

Guangzhou, Guangdong

• 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

Conditions: Cancer Cachexia, cachexia, cancer, GDF-15, IL-6