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

Brief description of study

This is a Phase 1/2 study testing a new oral cancer drug called S241656 (BDTX-4933 - an investigational anti-cancer drug) in patients whose cancers have mutations in KRAS, BRAF, or other genes in the RAS/MAPK pathway. S241656 (BDTX-4933) is a strong and selective drug that blocks RAF proteins, including abnormal BRAF and active RAF dimers caused by mutations in KRAS. This means it could slow or stop tumor growth in many cancers with RAS or RAF mutations, and may help overcome resistance seen with other treatments. The study will look at the drug alone (monotherapy) and in combination with other anti-cancer treatments to see if it is safe and helps control the cancer.

This study is multi-center and open-label, meaning it takes place at multiple hospitals, and both patients and doctors know what treatment is being given. The study has two main parts: finding the right dose (dose escalation) and expanding to see how well it works (dose optimization & expansion). In part 1 of the study, different doses of S241656 (BDTX-4933) will be tested to see if it is safe and to find the biologically effective dose. The drug will be tested alone and sometimes with other cancer treatments. After Part 1, researchers may fine-tune the best dose or move directly to expanding the study depending on safety and early effectiveness data. Part 2 of the study will test S241656 alone and with other cancer therapies. Patients must have cancers that did not respond to standard treatments, could not tolerate them, or refused them.

All patients will have frequent medical check ups and blood samples taken to see how their bodies are handling the study medicines. The study team will have special scans done for all patients to see how the cancer is responding to the study medicines. The study team will be monitoring the patients for potential side effects and safety concerns.


Clinical Study Identifier: s25-01034
ClinicalTrials.gov Identifier: NCT05786924
Principal Investigator: Paul E. Oberstein.
Other Investigators: Caitlin Elizabeth Ordonez Ferri, David R. Wise, Kelly C O'Sullivan, Elaine Shum, Shushma Upadhayay, Yoke Wah Khoo, Eneil De La Pena, Shun Yu, Maya Dimitrova, Elise M Zahriah, Anam Qureshi, Lourdes Gaddi, Jessica Wang, Jonathan B Kahn, Janice Mehnert, Joshua K Sabari, Keriann M Scavone, Zefie Kanos, Kirby Rodriguez, Nina Beri, Rajwanth Veluswamy, Kathleen M Lutz, Maria Francis, Salman Rafi Punekar, Michelle Diane Swanson Lightfoot, Carol M Lee, Paige Gugerty, Tiffany S Wang, Mariam M Cheaib, Jennifer Chuy, Zujun Li, Samantha VanMaanen, Manuel Hidalgo Medina, Daniel J Becker, Elise Roughan, Kristen Spencer, Kathleen M Madden, Nancy Chan, Paola De Leon, Rafael Winograd, Ruth A White, Matthew A. Ingham, Douglas K Marks.


If you are registered as a volunteer, please log in to contact the study team/express interest in this study.

Contact the research team to learn more about this study.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.