Phase 1b2 Evaluation of RASON Inhibitors Alone or with Standard Therapies in Adults with Advanced RAS-Mutated Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating novel RASON inhibitors alone or combined with standard treatments in adults with advanced RAS-mutated non-small cell lung cancer NSCLC and other solid tumors. This open-label Phase 1b2 platform study focuses on assessing safety, tolerability, drug behavior in the body, and early antitumor activity. The study includes patients with specific KRAS or RAS mutations and aims to determine the best dose and schedule for further study. The study has four subprotocols evaluating different combinations Subprotocol A tests RMC-6291 with or without RMC-6236 plus pembrolizumab and possibly chemotherapy for KRAS G12C-mutated tumors Subprotocol B uses RMC-6236 with pembrolizumab and possibly chemotherapy for RAS-mutated NSCLC Subprotocol C evaluates RMC-9805 with or without RMC-6236 plus other anticancer agents for RAS G12D-mutated NSCLC Subprotocol D studies RMC-9805 alone in previously treated RAS G12D-mutated NSCLC. Treatments involve oral tablets or intravenous infusions given at various schedules. Participants undergo screening to confirm eligibility, then receive assigned study treatments in dose exploration and expansion phases depending on subprotocol. Researchers monitor adverse effects up to five years and assess drug levels in the body during treatment. Tumor response and duration of response are also tracked long term. The total study duration may extend up to the study completion date in December 2028.

Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC