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

Inclusion criteria

• 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/eating problems related to cancer.
• It has adequate organ function.
• The ECOG PS score was 0-2.
• The investigator judged the expected survival time to be ≥ 3 months.

Exclusion criteria

• With active brain metastases.
• With other active diseases that lead to reduced food intake or seriously affect digestion and absorption
• Baseline BMI > 28 kg/m2.
• With infectious diseases.
• With clinically significant cardiovascular disease.
• With uncontrolled metabolic diseases.
• With known clinically significant allergic reactions to antibodies and excipients.
• With history of drug or alcohol abuse.
• Pregnant or lactating female subjects or women planning to become pregnant during the study.
• With pleural, peritoneal, or pericardial effusion that causes overt symptoms or requires repeated drainage (frequency ≥ 1 time/month).
• 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.