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New pill targets Hard-to-Treat cancers: early trial recruits 554 patients

NCT ID NCT05786924

Disease control Sponsor: Institut de Recherches Internationales Servier Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times

Summary

This study tests an experimental oral drug called S241656 (BDTX-4933) in people with advanced solid tumors that have certain genetic changes (KRAS, BRAF, or other RAS/MAPK mutations). The trial has two parts: first, finding a safe dose, then testing how well it works alone or with other cancer drugs. About 554 adults with lung, colorectal, pancreatic, or other cancers will take the drug daily in 28-day cycles. The goal is to see if the drug can shrink tumors or slow disease progression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
S241656 (also called BDTX-4933), an oral RAF inhibitor
What this could lead to
If successful, this could provide a new treatment option for people with advanced cancers that have specific genetic mutations (like KRAS or BRAF) and have not responded to other therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not work as hoped or could cause unexpected side effects. It is also testing many different cancer types and combinations, making it harder to prove benefit for any single group.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 554 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Life expectancy of ≥ 12 weeks in the opinion of the investigator. * Histologically or cytologically confirmed recurrent locally advanced (unresectable) or metastatic solid tumors with documented RAS or RAF mutations or alterations. * Adequate bone marrow and organ function. * Recovered from toxicity to prior anti-cancer therapy. Part 1 Dose Escalation cohort ONLY: * Part 1A: Advanced/metastatic NSCLC with KRAS non-G12C, HRAS, NRAS, BRAF or CRAF (RAF1) mutations or alterations * Part 1B: Advanced/metastatic GI tumors (e.g., PDAC, CRC, and BTC) with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations * Part 1C: Advanced/metastatic PDAC with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations * Part 1D: Colorectal adenocarcinoma with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations * Part 1E: Other advanced/metastatic non-GI, non-NSCLC solid tumors with KRAS, HRAS, NRAS, BRAF, CRAF (RAF1) mutations or alterations Part 2 Dose Optimization and Expansion cohorts ONLY: * Part 2A: Advanced/metastatic NSCLC with KRAS non-G12C mutations and/or BRAF mutations * Part 2A1: Advanced/metastatic NSCLC with KRAS non-G12C mutations * Part 2A2: Advanced/metastatic NSCLC with BRAF mutations * Part 2A3: Advanced/metastatic NSCLC with KRAS non-G12C or BRAF mutations or alterations and active CNS metastatic disease * Part 2A4: Advanced/metastatic NSCLC with a KRAS G12C mutation * Part 2B1: Advanced/metastatic PDAC with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations * Part 2B2: Advanced/metastatic CRC with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations * Part 2B3: Advanced/metastatic BTC (adenocarcinoma) with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations Key Exclusion Criteria: * Cancer that has a known MEK1/2 mutation. * Known allergy/hypersensitivity to excipients of S241656 or to any of the registered IMPs administered in combination. * Any contra-indication, to use of any of the combination chemotherapy or anti-EGFR therapy partners administered as part of this trial. * Major surgery within 4 weeks of study entry or planned during study. * Ongoing anticancer therapy. * Ongoing radiation therapy. * Uncontrolled or active clinically relevant bacterial, fungal, or specific viral infection requiring systemic therapy. * Clinically significant cardiovascular disease. * Symptomatic spinal cord compression. * Evidence of active malignancy (other than study-specific malignancies) requiring systemic therapy within the next 2 years. * History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO. * Females who are pregnant or breastfeeding. * Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study. * Prior use of experimental agents that target the KRAS/BRAF/MEK/ERK pathway.

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Conditions

The condition(s) this trial relates to.

biliary tract cancer brain cancer carcinoma colorectal cancer colorectal carcinoma colorectal neoplasm histiocytic and dendritic cell neoplasm histiocytic sarcoma histiocytosis lung cancer lung neoplasm metastatic malignant neoplasm metastatic malignant neoplasm in the brain neoplasm non-small cell lung carcinoma pancreatic ductal adenocarcinoma thyroid cancer thyroid gland carcinoma Thyroid Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acquired resistance to KRAS G12C inhibitor BRAF BRAF gene mutation BRAF mutation-related tumors BRAF V600 mutation BRAF V600E Brain metastases Colorectal cancer Colorectal carcinoma Histiocytic neoplasm Histiocytosis KRAS G12A KRAS G12D KRAS G12F KRAS G12R KRAS G12V KRAS G13C KRAS G13D KRAS mutation-related tumors Metastatic lung cancer Metastatic lung non-small cell carcinoma Non-small cell lung cancer NRAS gene mutation NSCLC Recurrent histiocytic and dendritic cell neoplasm Recurrent lung cancer Recurrent lung non-small cell carcinoma Recurrent NSCLC Solid carcinoma Solid tumor Thyroid cancer Thyroid carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    49 sites in 10 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AP-HP Hopital Europeen Georges Pompidou

    NOT_YET_RECRUITING

    Paris, 75015, France

  • Banner Health- MD Anderson Cancer Center

    RECRUITING

    Gilbert, Arizona, 85234, United States

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, 100142, China

  • Center for Cancer and Organ Diseases - Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

  • Centre Eugene Marquis

    NOT_YET_RECRUITING

    Rennes, 35042, France

  • Centre Georges Francois Leclerc

    NOT_YET_RECRUITING

    Dijon, 21079, France

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clinica Universidad de Navarra - Pamplona

    NOT_YET_RECRUITING

    Pamplona, 31008, Spain

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke University School of Medicine

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Fred Hutchinson Cancer Research Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Fudan University Zhongshan Hospital

    NOT_YET_RECRUITING

    Shanghai, 200032, China

  • Georgetown University Lombardi Cancer Center

    NOT_YET_RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Hammersmith Hospital

    RECRUITING

    London, W12 0HS, United Kingdom

  • Hospital Clinico Universitario de Valencia

    NOT_YET_RECRUITING

    Valencia, 646010, Spain

  • Hospital Universitario Vall d'Hebron

    NOT_YET_RECRUITING

    Barcelona, 8035, Spain

  • IFO - Istituto Nazionale dei Tumori Regina Elena

    NOT_YET_RECRUITING

    Rome, 00144, Italy

  • Institut Curie

    NOT_YET_RECRUITING

    Paris, 75005, France

  • Institut Gustave Roussy

    NOT_YET_RECRUITING

    Villejuif, 94805, France

  • Istituto Clinico Humanitas

    NOT_YET_RECRUITING

    Rozzano, 20089, Italy

  • Istituto Europeo di Oncologia

    NOT_YET_RECRUITING

    Milan, 20141, Italy

  • Kanagawa Cancer Center

    RECRUITING

    Kanagawa, 241-8515, Japan

  • Kyoto University Hospital

    RECRUITING

    Kyoto, 606-8507, Japan

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Masonic Cancer Center University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)

    RECRUITING

    New York, New York, 10016, United States

  • National Cancer Center Hospital

    RECRUITING

    Tokyo, 104-0045, Japan

  • Peter MacCallum Cancer Centre

    NOT_YET_RECRUITING

    East Melbourne, 3002, Australia

  • Prince of Wales

    RECRUITING

    Shatin, Hong Kong

  • Queen Mary Hospital

    RECRUITING

    Hong Kong, Hong Kong

  • START San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Sarah Canon Research Institute (SCRI) Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Shandong Cancer Hospital (Cancer Hospital of Shandong First Medical University)

    NOT_YET_RECRUITING

    Jinan, 250117, China

  • Sibley Memorial Hospital

    NOT_YET_RECRUITING

    Washington D.C., District of Columbia, 20016, United States

  • South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC

    NOT_YET_RECRUITING

    Madrid, 28050, Spain

  • South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz

    NOT_YET_RECRUITING

    Madrid, 28040, Spain

  • South Texas Accelerated Research Therapeutics (START) Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • The Angeles clinic - A cedars SINAI AFFILIATE

    RECRUITING

    Los Angeles, California, 90025, United States

  • The Christie NHS Foundation Trust

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The Second Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, 215004, China

  • USC Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • University College London Hospital

    RECRUITING

    London, NW1 2PG, United Kingdom

  • University of California, San Francisco (UCSF)

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Colorado - Aurora Cancer Center

    NOT_YET_RECRUITING

    Aurora, Colorado, 80045, United States

  • Washington University

    RECRUITING

    St Louis, Missouri, 63130, United States

  • Westmead Hospital

    NOT_YET_RECRUITING

    Westmead, NSW 2145, Australia

  • Yale University School of Medicine - Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06520-8028, United States

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Other studies related to the condition(s) this trial covers.