S241656: RAF inhibitor targeting all classes of oncogenic BRAF alterations (Classes I, II, and III) and constitutively active CRAF, KRAS or NRAS mutations
FOLFOX6/FOLFOX7: Used as a combination therapy and administered intravenously
FOLFIRI: Used as a combination therapy and administered intravenously
Cetuximab: Used as a combination therapy and administered intravenously
Panitumumab: Used as a combination therapy and administered intravenously
Gemcitabine: Used as a combination therapy and administered intravenously
Nab-paclitaxel: Used as a combination therapy and administered intravenously
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.
| Facility | City | Region | Status |
|---|---|---|---|
| Banner Health- MD Anderson Cancer Center | Gilbert | Arizona | Recruiting |
| The Angeles clinic - A cedars SINAI AFFILIATE | Los Angeles | California | Recruiting |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | Recruiting |
| University of California, San Francisco (UCSF) | San Francisco | California | Recruiting |
| University of Colorado - Aurora Cancer Center | Aurora | Colorado | Not Yet Recruiting |
| Yale University School of Medicine - Yale Cancer Center | New Haven | Connecticut | Recruiting |
| Georgetown University Lombardi Cancer Center | Washington D.C. | District of Columbia | Not Yet Recruiting |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | Not Yet Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| South Texas Accelerated Research Therapeutics (START) Midwest | Grand Rapids | Michigan | Recruiting |
| Masonic Cancer Center University of Minnesota | Minneapolis | Minnesota | Recruiting |
| Washington University | St Louis | Missouri | Recruiting |
| NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute) | New York | New York | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| Duke University School of Medicine | Durham | North Carolina | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| Sarah Canon Research Institute (SCRI) Oncology Partners | Nashville | Tennessee | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | Recruiting |
| START San Antonio | San Antonio | Texas | Recruiting |
| NEXT Virginia | Fairfax | Virginia | Recruiting |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | Recruiting |
| Peter MacCallum Cancer Centre | East Melbourne | Australia | Not Yet Recruiting |
| Westmead Hospital | Westmead | Australia | Not Yet Recruiting |
| Beijing Cancer Hospital | Beijing | China | Recruiting |
| Shandong Cancer Hospital (Cancer Hospital of Shandong First Medical University) | Jinan | China | Not Yet Recruiting |
| Fudan University Zhongshan Hospital | Shanghai | China | Not Yet Recruiting |
| The Second Affiliated Hospital of Soochow University | Suzhou | China | Recruiting |
| Center for Cancer and Organ Diseases - Rigshospitalet | Copenhagen | Denmark | Recruiting |
| Centre Georges Francois Leclerc | Dijon | France | Not Yet Recruiting |
| Institut Curie | Paris | France | Not Yet Recruiting |
| AP-HP Hopital Europeen Georges Pompidou | Paris | France | Not Yet Recruiting |
| Centre Eugene Marquis | Rennes | France | Not Yet Recruiting |
| Institut Gustave Roussy | Villejuif | France | Not Yet Recruiting |
| Queen Mary Hospital | Hong Kong | Hong Kong | Recruiting |
| Prince of Wales | Shatin | Hong Kong | Recruiting |
| Istituto Europeo di Oncologia | Milan | Italy | Not Yet Recruiting |
| IFO - Istituto Nazionale dei Tumori Regina Elena | Rome | Italy | Not Yet Recruiting |
| Istituto Clinico Humanitas | Rozzano | Italy | Not Yet Recruiting |
| Kanagawa Cancer Center | Kanagawa | Japan | Recruiting |
| Kyoto University Hospital | Kyoto | Japan | Recruiting |
+ 9 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05786924 on ClinicalTrials.gov ↗ ← All trials in China