First-in-Human Study of 7MW4911 for Gastrointestinal Cancer

Inclusion Criteria

• Must be 18 years or older.
• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Expected to live at least 3 more months.
• Have advanced or metastatic gastrointestinal cancer that has worsened after standard treatments.
• Cancer must have progressed after the most recent treatment.
• Have at least one tumor that can be measured using standard criteria.
• Able to provide a previous tumor sample or undergo a new biopsy.
• Have adequate blood, liver, and kidney function.
• Agree to use effective contraception during the study.

Exclusion Criteria

• Have another type of cancer within the last 3 years, except for certain treated skin cancers.
• Have untreated or symptomatic cancer that has spread to the brain or spinal cord.
• Have fluid buildup that requires frequent drainage.
• Have active autoimmune diseases, except for type I diabetes, hypothyroidism, or other conditions not needing systemic treatment.
• Have severe lung disease requiring hospitalization in the last 28 days.
• Have significant heart disease or events in the last 6 months.
• Have poorly controlled blood sugar levels.
• Have received a stem cell or organ transplant.
• Have active HIV or hepatitis B/C infections, or any infection needing IV treatment in the last 14 days.
• Have not recovered from side effects of previous cancer treatments, except for hair loss and hormone-related issues.
• Have received certain cancer treatments or surgeries recently, or are on specific medications that interfere with the study drug.
• Have an allergy to 7MW4911 or its ingredients.
• Abuse drugs or alcohol.
• Are pregnant or breastfeeding.
• Have any other conditions that the study doctor believes make participation unsuitable.