Phase 1/2 trial of S241656 in Selected RAS/MAPK Mutation-Positive Malignancies
Research type
Research Study
Full title
A Phase 1/2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination with Other Anti-Cancer Therapies in Patients with KRAS, BRAF and Other Selected RAS/MAPK Mutation-Positive Malignancies
IRAS ID
1013168
Contact name
Valerie Brunet
Contact email
Sponsor organisation
Insitut de Recherches Internationales Servier (I.R.I.S)
Clinicaltrials.gov Identifier
Research summary
This I.R.I.S study focuses on the development of a new treatment for certain types of cancer which are difficult to treat. The study focuses on certain mutations in five genes: KRAS, NRAS, HRAS, BRAF and CRAF. These mutations are common in cancers like lung cancer, pancreatic cancer, colorectal cancer, biliary tract cancer (the biliary tract consists of the gallbladder and the bile ducts, which produce, store, and release bile), and others. The study medication, S241656, is designed to block the effect of these mutations, which may stop cancer cells from growing. Researchers believe that by giving this new medication alone or in combination with other anti-cancer treatments, they can find better treatments for these cancers and improve the lives of people who have them. The study will have two parts, part 1 will look into the safety of S241656 with the main objective to look at the safety and tolerability of S241656 (at different increasing doses) alone or in combination with other anti-cancer treatments. Part 2 will look into the best dose of S241656 taking data from part 1 with the main objective to see how well S241656 works in treating the tumour, alone or in combination with other anti-cancer treatments. Overall there will be approximately 554 participants in the study and the total time of participation is anticipated to be 5 years. Participants will be enrolled into either part 1 or part 2 of the study, and each cohort will receive S241656 at various dose levels depending on the time of enrolment. The study will conclude after the last participant has completed their last follow-up visit or the last contact attempt if the last participant is declared lost to follow-up.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
26/NE/0015
Date of REC Opinion
17 Feb 2026
REC opinion
Further Information Favourable Opinion