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 study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centr Georges Francois Leclerc Dijon France
Hospital Universitario Hm Sanchinarro Madrid Spain
IRCCS Humanitas Research Hospital Rozzano Italy
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Rigshospitalet Copenhagen Denmark
Hopital Beaujon Clichy France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Idlwlh Iacajudo Fukvujlypigrt Opwlnwohifx Rome Italy
Haatayzr Vtor dzdvysge Barcelona Spain
Ieklikhb Cksjn Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not yet recruiting
17.04.2026
France France
Not yet recruiting
17.04.2026
Italy Italy
Not yet recruiting
17.04.2026
Spain Spain
Not yet recruiting
17.04.2026

Trial locations

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.

Paclitaxel is a medication used in chemotherapy, administered through an IV infusion to stop cancer cells from growing.

Irinotecan is a chemotherapy drug given through an IV infusion to treat certain types of cancer.

Fluorouracil is a common chemotherapy medication administered through an IV to treat cancer.

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 ID:
2025-523474-16-00
Protocol code:
BDTX-4933-101
NCT ID:
NCT05786924
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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