Study on IDE196 for Patients with Solid Tumors with GNAQ/11 Mutations or PRKC Fusions

Inclusion Criteria

• Must be 18 years or older.
• Have a diagnosis of one of the following:
  • Metastatic uveal melanoma (MUM) confirmed by lab tests.
  • Advanced cutaneous melanoma, colorectal cancer, or other solid tumors with GNAQ/11 mutations that have worsened after standard treatments or have no other treatment options.
• Have measurable disease that can be tracked.
• Be in good overall health with a performance status score of 0 or 1 and an expected life expectancy of more than 3 months.
• Have adequate organ function as determined by specific tests.
• Use effective birth control if of childbearing potential.

Additional Criteria for Binimetinib Combination:

• Have good heart function with a left ventricular ejection fraction (LVEF) of 50% or higher.

Additional Criteria for Crizotinib Combination:

• Have completed any prior chemotherapy, other treatments, or major surgeries at least 4 weeks before starting crizotinib.
• Have mild or no preexisting nerve damage (Grade 1 or lower) before starting crizotinib.

Exclusion Criteria

• Have known brain metastases causing symptoms.
• Have previously been treated with a PKC inhibitor.
• Have certain tumors (MSI-H/dMMR) that have not been treated with immune checkpoint inhibitors.
• Have unresolved side effects from previous cancer treatments.
• Have AIDS-related illness, hepatitis B, or hepatitis C.
• Have an active infection requiring treatment.
• Have had recent surgery or radiation therapy.
• Have had stomach or upper bowel surgery or any gastrointestinal disorder.
• Are pregnant or breastfeeding.
• Have impaired heart function.
• Are taking medications that cannot be stopped before the study.
• Have allergies to mammalian meat products and gelatin if receiving IDE196 powder-in-capsule or crizotinib.

Additional Exclusion Criteria for Binimetinib Combination:

• Have been treated with a MEK inhibitor before.
• Have a history or risk of retinal vein occlusion (RVO).
• Have a history of lung disease or blood clots within 12 weeks before the first dose.
• Have muscle disorders with high creatine phosphokinase (CPK) levels.
• Have uncontrolled high blood pressure.
• Have allergies to binimetinib or its components.
• Have a history of fainting.

Additional Exclusion Criteria for Crizotinib Combination:

• Have had therapy targeting ALK, MET, or ROS1.
• Have spinal cord compression.
• Have a history of lung inflammation or disease.
• Have a history of fainting.