First-in-human Study of 7MW4911 in GI Cancer
Trial Parameters
Brief Summary
This is the first-in-human study of 7MW4911 in US patients, to investigate its prelimary safety and efficacy in patients with gastrointestinal cancers.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 and above 2. ECOG 0-1 3. Life expectancy ≥ 3 months 4. Advanced or metastatic gastrointestinal cancer that has progressed after standard of care. 5. Disease progression after the most recent treatment regimen 6. At least one measurable lesion according to RECIST v1.1 7. Provision of archival tumor tissue or fresh biopsy. 8. Adequte hematologic funciton, liver function and renal function. 9. Comply with contraceptive requirements Exclusion Criteria: 1. Other concurrent malignancy in the recent 3 years except for adequately treated carcinoma in situ. 2. Active, untreated or symptomatic CNS metastasis 3. Effusions that require frequent drainage 4. Patients with active autoimmune disease, except for type I diabetes, hypothyroidism and other autoimmune disease that does not require systemic treatment. 5. Severe respiratory disease that required hospitalization in the last 28 days. 6. Significant and uncontrolled cardiovascular disease or events in the 6 months