Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies
Start Date
4/18/2023
Completion Date
6/1/2028
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
S241656
FOLFOX6/FOLFOX7
FOLFIRI
Cetuximab
Panitumumab
Gemcitabine
Nab-paclitaxel
Conditions
Locations
Banner Health- MD Anderson Cancer Center
Gilbert, Arizona 85234
United States
The Angeles clinic - A cedars SINAI AFFILIATE
Los Angeles, California 90025
United States
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
University of California, San Francisco (UCSF)
San Francisco, California 94143
United States
University of Colorado - Aurora Cancer Center
Aurora, Colorado 80045
United States
Yale University School of Medicine - Yale Cancer Center
New Haven, Connecticut 06520-8028
United States
Georgetown University Lombardi Cancer Center
Washington D.C., District of Columbia 20007
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan 49546
United States
Masonic Cancer Center University of Minnesota
Minneapolis, Minnesota 55455
United States
Washington University
St Louis, Missouri 63130
United States
NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)
New York, New York 10016
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Duke University School of Medicine
Durham, North Carolina 27710
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
Sarah Canon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee 37203
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
START San Antonio
San Antonio, Texas 78229
United States
NEXT Virginia
Fairfax, Virginia 22031
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109
United States
Center for Cancer and Organ Diseases - Rigshospitalet
Copenhagen, 2100
Denmark
Queen Mary Hospital
Hong Kong,
Hong Kong
Kyoto University Hospital
Kyoto, 606-8507
Japan
National Cancer Center Hospital
Tokyo, 104-0045
Japan
University College London Hospital
London, NW1 2PG
United Kingdom
Hammersmith Hospital
London, W12 0HS
United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX
United Kingdom