Condition: Non-small Cell Lung Cancer · Histiocytic Neoplasm · Histiocytosis · Sponsor: Institut de Recherches Internationales Servier
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.
This description comes directly from the study's public registry record.
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department · +33 1 55 72 60 00 · scientificinformation@servier.com
Always discuss trial participation with your own doctor first.
| Banner Health- MD Anderson Cancer Center | Gilbert, Arizona, United States | Recruiting |
| The Angeles clinic - A cedars SINAI AFFILIATE | Los Angeles, California, United States | Recruiting |
| USC Norris Comprehensive Cancer Center | Los Angeles, California, United States | Recruiting |
| University of California, San Francisco (UCSF) | San Francisco, California, United States | Recruiting |
| University of Colorado - Aurora Cancer Center | Aurora, Colorado, United States | Not Yet Recruiting |
| Yale University School of Medicine - Yale Cancer Center | New Haven, Connecticut, United States | Recruiting |
| Georgetown University Lombardi Cancer Center | Washington D.C., District of Columbia, United States | Not Yet Recruiting |
| Dana-Farber Cancer Institute | Boston, Massachusetts, United States | Recruiting |
| South Texas Accelerated Research Therapeutics (START) Midwest | Grand Rapids, Michigan, United States | Recruiting |
| Masonic Cancer Center University of Minnesota | Minneapolis, Minnesota, United States | Recruiting |
| Washington University | St Louis, Missouri, United States | Recruiting |
| NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute) | New York, New York, United States | Recruiting |
+ 15 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05786924