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

ClinicalTrials.gov ID: NCT05786924

Public ClinicalTrials.gov record NCT05786924. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 17, 2026, 2:37 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1/2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With KRAS, BRAF and Other Selected RAS/MAPK Mutation-Positive Malignancies

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT05786924
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Institut de Recherches Internationales Servier; Other
Enrollment: 554 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 18, 2023 (Actual)
Primary completion: Jun 2028 (Estimated)
Completion: Jun 2028 (Estimated)
Last update posted: Oct 13, 2026

2023 – 2028

United States locations

U.S. sites: 21
U.S. states: 16
U.S. cities: 18

Facility	City	State	ZIP	Site status
Banner Health- MD Anderson Cancer Center	Gilbert	Arizona	85234	Recruiting
The Angeles clinic - A cedars SINAI AFFILIATE	Los Angeles	California	90025	Recruiting
USC Norris Comprehensive Cancer Center	Los Angeles	California	90033	Recruiting
University of California, San Francisco (UCSF)	San Francisco	California	94143	Recruiting
University of Colorado - Aurora Cancer Center	Aurora	Colorado	80045	Not yet recruiting
Yale University School of Medicine - Yale Cancer Center	New Haven	Connecticut	06520-8028	Recruiting
Georgetown University Lombardi Cancer Center	Washington D.C.	District of Columbia	20007	Not yet recruiting
Sibley Memorial Hospital	Washington D.C.	District of Columbia	20016	Not yet recruiting
Dana-Farber Cancer Institute	Boston	Massachusetts	02215	Recruiting
South Texas Accelerated Research Therapeutics (START) Midwest	Grand Rapids	Michigan	49546	Recruiting
Masonic Cancer Center University of Minnesota	Minneapolis	Minnesota	55455	Recruiting
Washington University	St Louis	Missouri	63130	Recruiting
NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)	New York	New York	10016	Recruiting
Memorial Sloan Kettering Cancer Center	New York	New York	10065	Recruiting
Duke University School of Medicine	Durham	North Carolina	27710	Recruiting
Cleveland Clinic	Cleveland	Ohio	44195	Recruiting
Sarah Canon Research Institute (SCRI) Oncology Partners	Nashville	Tennessee	37203	Recruiting
MD Anderson Cancer Center	Houston	Texas	77030	Recruiting
START San Antonio	San Antonio	Texas	78229	Recruiting
NEXT Virginia	Fairfax	Virginia	22031	Recruiting
Fred Hutchinson Cancer Research Center	Seattle	Washington	98109	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05786924, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 13, 2026 · Synced Oct 17, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05786924 live on ClinicalTrials.gov.

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