Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
BDTX-4933-101 is a first-in-human, open-label, Phase 1/2 dose escalation, dose optimization and expansion study designed to evaluate the safety and tolerability of S241656 as monotherapy and in combination with other anti-cancer therapies in participants with selected advanced malignancies. The study population for the Dose Escalation part of the study comprises adults with recurrent advanced/metastatic non-small cell lung cancer (NSCLC), Gastrointestinal (GI) cancers, and other solid tumors harboring KRAS, HRAS, NRAS, BRAF, and/or CRAF (Rapidly Accelerated Fibrosarcoma (RAF1)) mutations or alterations. A dose optimization part in adults with NSCLC may follow the dose escalation phase if the sponsor, in consultation with the safety review committee, decides it is necessary to further characterize the optimal dose. However, the study may also proceed directly to the expansion phase. The study population for the Dose Expansion part of the study comprises adults with advanced/metastatic NSCLC with KRAS and/or BRAF mutations, and with Pancreatic Ductal AdenoCarcinoma (PDAC), ColoRectal Cancer (CRC), and Biliary Tract Cancer (BTC) with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations and alterations. All patients will self-administer S241656 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Oczekiwana długość życia co najmniej 12 tygodni
- •Zaawansowany lub przerzutowy nowotwór potwierdzoną mutacją RAS lub RAF
- •Wystarczająca funkcja szpiku kostnego i narządów
- •Wyzdrowienie z efektów ubocznych poprzednich terapii przeciwnowotworowych
- •Rak płuca (NSCLC) z odpowiednimi mutacjami OR nowotwory przewodu pokarmowego OR inne zaawansowane nowotwory z określonymi mutacjami
✗ Disqualifies
- •Nowotwór z mutacją MEK1/2
- •Alergia na składniki leku S241656 lub leki stosowane w kombinacji
- •Wcześniejsza hipersensytywność na komponenty badanego preparatu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 16, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (49)
Banner Health- MD Anderson Cancer Center
Gilbert, United States
The Angeles clinic - A cedars SINAI AFFILIATE
Los Angeles, United States
USC Norris Comprehensive Cancer Center
Los Angeles, United States
University of California, San Francisco (UCSF)
San Francisco, United States
University of Colorado - Aurora Cancer Center
Aurora, United States
Yale University School of Medicine - Yale Cancer Center
New Haven, United States
Georgetown University Lombardi Cancer Center
Washington D.C., United States
Sibley Memorial Hospital
Washington D.C., United States
Dana-Farber Cancer Institute
Boston, United States
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, United States
Masonic Cancer Center University of Minnesota
Minneapolis, United States
Washington University
St Louis, United States
NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)
New York, United States
Memorial Sloan Kettering Cancer Center
New York, United States
Duke University School of Medicine
Durham, United States
Cleveland Clinic
Cleveland, United States
Sarah Canon Research Institute (SCRI) Oncology Partners
Nashville, United States
MD Anderson Cancer Center
Houston, United States
START San Antonio
San Antonio, United States
NEXT Virginia
Fairfax, United States
Fred Hutchinson Cancer Research Center
Seattle, United States
Peter MacCallum Cancer Centre
East Melbourne, Australia
Westmead Hospital
Westmead, Australia
Beijing Cancer Hospital
Beijing, China
Shandong Cancer Hospital (Cancer Hospital of Shandong First Medical University)
Jinan, China
Fudan University Zhongshan Hospital
Shanghai, China
The Second Affiliated Hospital of Soochow University
Suzhou, China
Center for Cancer and Organ Diseases - Rigshospitalet
Copenhagen, Denmark
Centre Georges Francois Leclerc
Dijon, France
Institut Curie
Paris, France
AP-HP Hopital Europeen Georges Pompidou
Paris, France
Centre Eugene Marquis
Rennes, France
Institut Gustave Roussy
Villejuif, France
Queen Mary Hospital
Hong Kong, Hong Kong
Prince of Wales
Shatin, Hong Kong
Istituto Europeo di Oncologia
Milan, Italy
IFO - Istituto Nazionale dei Tumori Regina Elena
Rome, Italy
Istituto Clinico Humanitas
Rozzano, Italy
Kanagawa Cancer Center
Kanagawa, Japan
Kyoto University Hospital
Kyoto, Japan
National Cancer Center Hospital
Tokyo, Japan
Hospital Universitario Vall d'Hebron
Barcelona, Spain
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
Madrid, Spain
South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC
Madrid, Spain
Clinica Universidad de Navarra - Pamplona
Pamplona, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
University College London Hospital
London, United Kingdom
Hammersmith Hospital
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
Trial contact
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/17/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.