Phase 12 Study of Oral S241656 Alone and With Other Cancer Treatments in Adults With Advanced KRAS, BRAF, and Other RASMAPK Mutation-Positive Cancers

What this Trial Is About

Researchers are evaluating the safety and tolerability of the drug S241656, both alone and combined with other anti-cancer treatments, in adults with advanced or metastatic cancers that have specific mutations in genes like KRAS, HRAS, NRAS, BRAF, and CRAF. This Phase 12 open-label study includes patients with non-small cell lung cancer, gastrointestinal cancers, pancreatic, colorectal, and biliary tract cancers carrying these mutations. The study aims to find the best dose and monitor how the drug works and its side effects. Participants will self-administer S241656 orally in 28-day cycles until their disease progresses, side effects become unacceptable, they withdraw consent, or the study ends. The study includes a dose escalation phase to determine the biologically effective dose BED, a dose optimization phase for non-small cell lung cancer if needed, and a dose expansion phase involving specific cancer types. S241656 may be given alone or in combination with other chemotherapy drugs such as gemcitabine, nab-paclitaxel, FOLFOX, FOLFIRI, panitumumab, or cetuximab depending on the study part. Throughout the study, participants will be monitored for dose-limiting toxicities during the first cycle, overall adverse events, and objective tumor responses over approximately five years. Researchers will assess drug levels in the blood, disease control, clinical benefit, duration and timing of response, progression-free and overall survival, and genetic changes in tumor DNA. Safety and dose adjustments will be tracked continuously. The trial is designed to gather detailed information on treatment effects and tolerability in this patient group.

Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies