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A study of S-241656 and a drug combination in patients with certain types of cancer involving KRAS, BRAF, or other RAS/MAPK mutations

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Malignancies, which is a general term for cancers, that have specific genetic changes known as KRAS, BRAF, or other RAS/MAPK mutations. These mutations are abnormal changes in the genes that control how cells grow and divide. The purpose of the study is to evaluate the safety and effectiveness of the drug S-241656, both when used alone and when combined with other cancer treatments.

The medications being studied include S-241656, which is taken as an oral tablet, and several other drugs administered through an intravenous method, which means they are delivered directly into a vein. These other medications include oxaliplatin, cetuximab, panitumumab, gemcitabine, paclitaxel, irinotecan, fluorouracil, and folinic acid. During the study, different doses of these treatments may be used to determine the most appropriate amount for patients.

The study is divided into two main stages. In the first stage, the focus is on finding the safest dose of the medication. In the second stage, the study looks at how well the treatment works to shrink or control the cancer. Throughout the process, the way the body processes the medicine is also observed.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the study

    After joining the study, the primary goal is to evaluate how the body reacts to the medication S-241656, which is taken as a pill, and to see how well it works when used alone or combined with other anti-cancer therapies.

    The study is divided into two main parts: dose escalation and dose expansion.

  2. Step 2

    Dose escalation phase

    During this phase, the safety and how well the body tolerates S-241656 is assessed. this involves testing different amounts of the medication, either by itself or in combination with other treatments.

    The medication S-241656 is administered orally in various tablet strengths, including 25mg, 50mg, and 200mg tablets.

    The safety is monitored specifically for any side effects or toxicities, which are harmful effects, that occur during the first 28-day cycle.

  3. Step 3

    Dose expansion phase

    This phase focuses on measuring the antitumor activity, which refers to how effectively the medication works to shrink or stop the growth of tumors.

    The medication S-241656 may be given as a monotherapy, meaning it is the only treatment used, or in combination with other drugs.

    Other medications that may be used during the study include oxaliplatin, folinic acid, cetuximab, panitumumab, gemcitabine, paclitaxel, irinotecan, or fluorouracil, which are delivered through an intravenous infusion, meaning they are put directly into a vein.

Who can join the trial?

8 criteria

  • You must have a life expectancy of at least 12 weeks, as determined by your doctor.
  • You must have a solid tumor, which is a type of cancer that forms a lump or mass, that has returned or spread to other parts of the body.
  • Your cancer must be confirmed through histology (looking at tissue samples under a microscope) or cytology (looking at individual cells under a microscope).
  • Your cancer must have specific genetic mutations, which are permanent changes in your DNA, specifically in the RAS or RAF genes.
  • You must have adequate bone marrow function, meaning your body can properly produce blood cells, and adequate organ function, meaning your vital organs like your liver or kidneys are working well.
  • You must have fully recovered from any toxicity, which refers to harmful side effects, caused by previous cancer treatments.
  • For certain parts of the study, you may need to have non-small cell lung cancer (NSCLC), gastrointestinal (GI) tumors (such as pancreatic, colorectal, or bile duct cancers), or other types of advanced or metastatic cancers, which means the cancer has spread to other parts of the body.
  • Some groups in the study may include patients with CNS metastatic disease, which means the cancer has spread to the central nervous system (the brain or spinal cord).

Who cannot join the trial?

15 criteria

  • Having cancer that is known to have a MEK1/2 mutation, which is a specific change or error in the genetic code of certain cells.
  • Being currently treated with anticancer therapy, which refers to medicines or treatments used to fight cancer.
  • Currently undergoing radiation therapy, which is a treatment that uses high doses of energy to kill cancer cells.
  • Having an active or uncontrolled infection caused by bacteria, fungi, or specific viruses that requires medicine to be taken throughout the whole body.
  • Having cardiovascular disease, which means a significant problem with the heart or blood vessels.
  • Having symptomatic spinal cord compression, which is when pressure is put on the spinal cord, causing symptoms like pain or weakness.
  • Having a history of or current signs of interstitial lung disease, pneumonitis (inflammation of lung tissue), or pulmonary fibrosis (scarring of the lungs).
  • Having another type of active malignancy, which is another word for cancer, that will require body-wide medicine within the next 2 years.
  • Having a history of or current risk for retinal vein occlusion, which is a blockage in the blood vessels at the back of the eye.
  • Being pregnant or currently breastfeeding.
  • Currently taking part in another clinical study that involves systemic treatment (medicine that travels through the whole body) or direct medical intervention.
  • Having previously used experimental medicines that target the KRAS, BRAF, MEK, or ERK pathway, which are specific chemical signals inside cells that help them grow.
  • Having a known allergy or hypersensitivity to the inactive ingredients in the study drug or to any of the other medicines used in the study.
  • Having any medical reason why you cannot use the chemotherapy or anti-EGFR therapy that are being used alongside the study drug.
  • Having major surgery within 4 weeks of starting the study or planning to have surgery during the study period.
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Investigated drugs

  • Folinic acid

    is an injectable medication given through a vein, used to support the body during certain cancer treatments.

  • Oxaliplatin

    is a medication delivered through an IV infusion used as a type of chemotherapy to treat cancer.

  • S-241656

    is an oral medication taken by mouth that is being studied for its ability to fight cancer cells.

  • Cetuximab

    is a treatment given through an IV infusion that targets specific proteins on cancer cells.

  • Panitumumab

    is a therapy administered through an IV infusion designed to block certain signals that help cancer cells grow.

  • Gemcitabine

    is a chemotherapy medication given through an IV infusion to treat various types of cancer.

What is already known about the treatment

  • Folinic acid

    This medication is administered as a solution through an intravenous infusion. It is a well-established vitamin derivative used to reduce the harmful side effects of certain cancer treatments. It works at the molecular level by providing a source of folate that helps protect healthy cells during chemotherapy. This substance is classified as an antimetabolite or vitamin supplement.

  • Oxaliplatin

    This drug is given as a solution for infusion directly into a vein. It is a widely used chemotherapy agent used to treat various types of cancer. Its mechanism of action involves binding to and damaging the DNA of cancer cells, which prevents them from multiplying. It is pharmacologically classified as a platinum-based antineoplastic agent.

  • S-241656

    This substance is administered orally in the form of a film-coated tablet. It is currently an investigational drug being studied in clinical trials for its potential to treat cancers with specific genetic mutations. It works by targeting and inhibiting specific proteins that allow cancer cells to grow and survive. This medication is classified as a targeted therapy inhibitor.

  • Cetuximab

    This medication is provided as a solution for intravenous infusion. It is an approved medicine used primarily to treat certain types of colorectal and head and neck cancers. It works by attaching to specific receptors on the surface of cancer cells to block the signals that tell them to grow. It is pharmacologically classified as a monoclonal antibody.

  • Panitumumab

    This drug is administered via intravenous infusion as a concentrate. It is a recognized medical treatment used for specific advanced cancers, such as colorectal cancer. It functions by blocking growth factor receptors on the outside of cancer cells, thereby stopping the spread of the disease. It is classified as a monoclonal antibody.

  • Gemcitabine

    This medication is administered as a solution for intravenous infusion. It is a standard chemotherapy drug used to treat several types of solid tumors, including pancreatic and lung cancer. It works by mimicking the building blocks of DNA, which causes cancer cells to stop growing when they try to replicate. It is classified as an antimetabolite.

Investigated diseases

Malignancies with Documented KRAS, BRAF and Other Selected RAS/MAPK Mutations - This group of cancers is characterized by specific changes in the genes that control how cells grow and divide. These mutations occur within certain signaling pathways, such as the RAS/MAPK pathway, which normally sends signals from the cell surface to the nucleus. When these genes are mutated, the pathway remains constantly active, leading to uncontrolled cell multiplication. As the disease progresses, the abnormal cells continue to divide and spread throughout the body. This continuous growth can lead to the formation of tumors in various tissues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2025-523474-16-00Protocol codeBDTX-4933-101Estimated enrolment567 patientsSponsorInstitut De Recherches Internationales Servier IRIS

sourced from the EU Clinical Trials Register and site verification

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