Study on S095035 Alone and in Combination for Adults with Advanced or Metastatic Solid Tumors with MTAP Deletion

Inclusion Criteria

• Life expectancy of at least 3 months.
• Good overall health with an ECOG performance status of 0 or 1.
• Ability to use effective birth control methods.
• Have a confirmed diagnosis of advanced or metastatic solid tumors (excluding certain brain tumors) that have progressed after at least one prior treatment and have no other effective standard treatments available.
• Have a documented MTAP gene deletion in tumor tissue, confirmed by a specific genetic test.
• For Phase 1, willing to undergo a biopsy procedure unless there are safety concerns.
• For Phase 2, provide a new tumor biopsy or recent archival tissue if new biopsy is not feasible.
• Specific criteria for different arms of Phase 2, including types of cancer like non-small cell lung cancer, bile duct cancer, pancreatic cancer, and others, all with MTAP deletion and progression after prior treatment.

Exclusion Criteria

• Unable to take oral medication or have conditions affecting drug absorption.
• Have another active cancer, except for certain non-threatening types.
• Severe allergy to study drug components.
• Recent major surgery or not recovered from surgery effects.
• History of Gilbert's syndrome.
• Significant heart disease or recent blood clots.
• Active brain metastases.
• Recent cancer treatment or radiation.
• Pregnant or breastfeeding women.
• Positive pregnancy test for women of childbearing potential.
• Recent gastrointestinal perforation or fistula.
• Severe or uncontrolled infections.
• Previous treatment with MAT2A or PRMT5 inhibitors.
• Conditions causing increased sensitivity to sunlight.