First-in-human Study of 7MW4911 in GI Cancer

Prior treatment

• Other concurrent malignancy in the recent 3 years except for adequately treated carcinoma in situ.
• Significant and uncontrolled cardiovascular disease or events in the 6 months prior to study drug administration
• Recipient of allogeneic stem cell transplant or organ transplant
• Active HIV or hepatitis B/C infection. Infection requiring systemic IV in the 14 days prior to study drug administration.
• Experiencing toxicities from prior anti-cancer therapies that have not recovered to CTCAE grade 0-1, except for alopecia and endocrinopathies.
• Prohibited treatment and treatment that requires washout period
  • Has received another Topo-I payload ADC, and/or another CDH17 targeting therapy.
  • Received other cancer therapy within 5 half-lives or 21 days prior to study drug administration.
  • Major surgeries within 28 days prior to study drug administration
  • Investigational therapy within 28 days prior to study drug administration
  • Systemic treatment with immunosuppressive agents within 28 days prior to first drug administration. Physiological dose of glucocorticoid, topical glucocorticoid are allowed.
  • Use of strong CYP3A4 inhibitor or inducer
• Abuse of narcotic or psychoactive drugs

Other illness

• Patients with active autoimmune disease, except for type I diabetes, hypothyroidism and other autoimmune disease that does not require systemic treatment.
• Severe respiratory disease that required hospitalization in the last 28 days.
• Known hypersensitivity to 7MW4911 or components of the formulation
• Other circumstances or conditions where the investigator judges to be unsuitable for study.

Lab values

• Poorly controlled blood glucose with fasting blood glucose above 10mmol/L

Other

• Active, untreated or symptomatic CNS metastasis
• Effusions that require frequent drainage
• Pregnant or breastfeeding women

• Aged 18 and above
• ECOG 0-1
• Life expectancy ≥ 3 months
• Advanced or metastatic gastrointestinal cancer that has progressed after standard of care.
• Disease progression after the most recent treatment regimen
• At least one measurable lesion according to RECIST v1.1
• Provision of archival tumor tissue or fresh biopsy.
• Adequte hematologic funciton, liver function and renal function.
• Comply with contraceptive requirements