Study on Lurbinectedin for Patients with Advanced Gastrointestinal Cancers with DNA Repair Mutations

Inclusion Criteria

• Must provide written consent to participate in the study.
• Must be 18 years or older, male or female.
• Must be in good general health, able to perform daily activities with minimal restrictions.
• Must have a confirmed diagnosis of gastrointestinal cancer.
• Cancer must be advanced and cannot be removed by surgery.
• Must have specific mutations in DNA repair genes like BRCA1, BRCA2, or others listed.
• Cancer must have progressed after previous treatments, or previous treatments were not tolerated.
• Must have measurable tumors based on specific criteria.
• Must have adequate blood counts and organ function as determined by blood tests.
• Must have stopped previous cancer treatments for a specified period before starting the study.
• Women must not be pregnant and must use effective birth control during the study and for six weeks after. Men must also use birth control if their partners are of childbearing potential.

Exclusion Criteria

• Have previously been treated with lurbinectedin or trabectedin.
• Have a specific subtype of cancer called neuroendocrine differentiation.
• Have had more than three previous chemotherapy treatments for advanced cancer.
• Have known brain metastases or cancer spread to the brain or spinal cord.
• Have certain heart conditions or symptoms.
• Have significant fluid buildup in the body that requires drainage.
• Have a weakened immune system or active infections like HIV, hepatitis B, or hepatitis C.
• Have any other major illness that could increase the risk of participating in the study.
• Are pregnant or breastfeeding.
• Have received a live vaccine within three weeks before starting the study.