Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions

Open to people ages 18 years and up

• Patient must be ≥18 years of age
• Diagnosis of one of the following:
• MUM: Uveal melanoma with histological or cytological confirmed metastatic disease. Or
• Non-MUM: Advanced cutaneous melanoma, colorectal cancer, or other solid tumor that has progressed following prior standard therapies or that has no satisfactory alternative therapies and has evidence of GNAQ/11 hotspot mutation
• Measurable disease
• Eastern Cooperative Oncology Group ≤1 and expected life expectancy of > 3 months
• Adequate organ function at screening
• Adequate contraceptive measures for non-sterilized male and female patients of childbearing potential

• Another malignancy
• Previous treatment with a PKC inhibitor
• Known microsatellite instability-high (MSI-H) tumors
• Adverse events from prior anti-cancer therapy that have not resolved
• Untreated or symptomatic central nervous system metastases
• Human immunodeficiency virus, acquired immunodeficiency syndrome related illness, hepatitis B virus, or hepatitis C virus
• Recent surgery or radiotherapy
• Females who are pregnant or breastfeeding
• Impaired cardiac function
• For patients receiving IDE196 powder-in-capsule (PIC) formulation, allergy to mammalian meat products and gelatin

Binimetinib Combination Additional Exclusion Criteria

• Patient has received prior treatment with a MEK inhibitor
• History of interstitial lung disease
• History or current evidence of central serous retinopathy (CSR) or retinal vein occlusion (RVO); History of retinal degenerative disease
• Concurrent neuromuscular disorders that are associated with elevated Creatine Kinase (CK)
• Allergy to binimetinib or its components