Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies

Recruiting now · Phase 1/Phase 2

Conditions studied: Non-small Cell Lung Cancer, Histiocytic Neoplasm, Histiocytosis, BRAF Gene Mutation, BRAF V600E, BRAF V600 Mutation, BRAF Mutation-Related Tumors, BRAF, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Lung Cancer, Recurrent Lung Cancer, Recurrent Lung Non-Small Cell Carcinoma, NSCLC, Solid Tumor, Solid Carcinoma, KRAS G12D, KRAS G12V, KRAS Mutation-Related Tumors, NRAS Gene Mutation, Thyroid Cancer, Thyroid Carcinoma, Colorectal Cancer, Colorectal Carcinoma, Recurrent Histiocytic and Dendritic Cell Neoplasm, Brain Metastases, Recurrent NSCLC, KRAS G13C, Acquired Resistance to KRAS G12C Inhibitor, KRAS G12A, KRAS G12F, KRAS G12R, KRAS G13D

In brief

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.

Key facts

Study ID

NCT05786924

Run by

Institut de Recherches Internationales Servier

People needed

554

Starts

2023-04-18

Expected to finish

2028-06-01

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• The Christie NHS Foundation Trust — Manchester, United Kingdom (enrolling)
• The Angeles clinic - A cedars SINAI AFFILIATE — Los Angeles, California, United States (enrolling)
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• University of California, San Francisco (UCSF) — San Francisco, California, United States (enrolling)
• Hammersmith Hospital — London, United Kingdom (enrolling)
• Banner Health- MD Anderson Cancer Center — Gilbert, Arizona, United States (enrolling)
• Yale University School of Medicine - Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• South Texas Accelerated Research Therapeutics (START) Midwest — Grand Rapids, Michigan, United States (enrolling)
• Masonic Cancer Center University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Washington University — St Louis, Missouri, United States (enrolling)
• NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute) — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Duke University School of Medicine — Durham, North Carolina, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Sarah Canon Research Institute (SCRI) Oncology Partners — Nashville, Tennessee, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• START San Antonio — San Antonio, Texas, United States (enrolling)
• NEXT Virginia — Fairfax, Virginia, United States (enrolling)
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States (enrolling)
• Center for Cancer and Organ Diseases - Rigshospitalet — Copenhagen, Denmark (enrolling)
• Queen Mary Hospital — Hong Kong, Hong Kong (enrolling)
• Kyoto University Hospital — Kyoto, Japan (enrolling)
• National Cancer Center Hospital — Tokyo, Japan (enrolling)
• University College London Hospital — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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