Study of Oral RMC-6236 for Adults with Advanced Solid Tumors Having Specific RAS Mutations Phase 12 Multicenter Trial Evaluating Safety, Dosing, and Effectiveness

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and clinical activity of RMC-6236, an oral drug targeting specific RAS mutations, in adults with advanced solid tumors. This Phase 12, multicenter, open-label study aims to find the maximum tolerated dose and recommended dose for further study among patients with tumors harboring particular KRAS, NRAS, or HRAS mutations. RMC-6236 selectively inhibits active RAS forms, which are involved in cancer growth. The study includes a dose exploration phase open to any advanced solid tumor with KRAS p.G12 mutations, followed by dose expansion or optimization in groups with specific tumor types and RAS mutations, such as non-small cell lung cancer, pancreatic ductal adenocarcinoma, colorectal cancer, melanoma, and gynecological cancers. Participants receive escalating doses of RMC-6236 taken orally. The study evaluates dose-limiting toxicities and monitors drug levels in the blood over several weeks. Participants will undergo safety assessments including monitoring adverse events, lab tests, and vital signs for up to 2.5 years, along with evaluations of response rates, disease control, and progression-free survival. The study tracks how the drug is processed in the body and records any treatment-related toxicities. Participants may be followed long-term to observe the duration of response and overall clinical outcomes.

Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS