Phase 12 Study of IDE196 Alone or with Binimetinib or Crizotinib for Solid Tumors with GNAQ11 Mutations or PRKC Fusions

What this Trial Is About

Researchers are evaluating the safety and anti-tumor activity of IDE196 in patients with solid tumors that have specific mutations in GNAQ or GNA11 genes or PRKC fusions. This includes metastatic uveal melanoma, cutaneous melanoma, colorectal cancer, and other solid tumors. The study is a Phase 12, multi-center, open-label trial designed to find the best dose and assess how well IDE196 works alone or combined with other drugs. The study involves different treatment groups IDE196 given orally twice daily alone, IDE196 combined with Binimetinib, and IDE196 combined with Crizotinib, all administered in 28-day cycles. There are dose escalation phases to determine recommended doses and dose expansion phases to further assess safety and anti-tumor activity. Some patients receive Crizotinib alone initially and may cross over to combination therapy. Additional sub-studies evaluate drug interactions and pharmacokinetics with other medications. Participants will take oral study drugs twice daily and undergo regular safety and effectiveness evaluations, including measuring tumor response and drug levels in the blood. Safety monitoring covers dose-limiting toxicities, adverse events, and recommended dosing. The study also tracks progression-free survival and response duration over several months. Participation includes multiple visits for assessments, imaging, and laboratory tests over the study period, which may last several months to years based on treatment and follow-up needs.

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