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

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Servier Protocol Code: BDTX-4933-101 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT05786924 EU Trial (CTIS) Number: 2025-523474-16-00

Find a recruiting site

How to participate in this study
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you can’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 10 locations

Study description

This study is needed to find new treatments for certain types of cancer that are difficult to treat. These cancers have changes in their genes (hereditary material), called mutations, which can affect signals in cells that help cells grow and survive. This causes uncontrolled cell growth and cancer. The study focuses on certain mutations in five genes: KRAS, NRAS, HRAS, BRAF and CRAF. These mutations are common in cancers like lung cancer, pancreatic cancer, colorectal cancer, biliary tract cancer (the biliary tract consists of the gallbladder and the bile ducts, which produce, store, and release bile), and others.

The study drug, S241656, is designed to block the effect of these mutations, which may stop cancer cells from growing.

Researchers hope that by giving this new drug alone or combined with other anti-cancer treatments, they can find better treatments for these cancers and improve the lives of people who have them. This research is crucial because current treatments don’t work well enough for these cancers, and patients need better options.

The main goals of the study are:

  • For Part 1, to look at the safety and tolerability of S241656 (at different increasing doses) alone or in combination with other anti-cancer treatments.
  • For Part 2, to see how well S241656 works in treating the tumor, alone or in combination with other anti-cancer treatments.
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
Protocol
English (USA)
Conditions
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
Interventions / Treatments
  • S241656
  • FOLFOX6/FOLFOX7
  • FOLFIRI
  • Cetuximab
  • Panitumumab
  • Gemcitabine
  • Nab-paclitaxel
Other study id numbers
  • BDTX-4933-101

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sex

Male/Female

Accepts Healthy Volunteers

No

To take part, participants have to:

  • Be adults aged 18 years or older.
  • Have a tumor with a specific mutation in the KRAS, NRAS, HRAS, BRAF and/or CRAF genes.
  • Have received at least one anti-cancer treatment before starting the study.
  • Have adequate organ and bone marrow function.

Participants cannot take part in the study if:

  • They have a tumor with a mutation in the MEK1/2 genes.
  • They are currently undergoing treatment for their cancer.

How is the study designed?

Allocation
Non-randomized
Interventional study model
Sequential
Participant Group / Arm
Experimental: Part 1: Dose Escalation

Small groups of participants will receive different doses and/or dose schedules of S241656 alone or in combination with other anti-cancer treatments to determine the best and safest dose. This part is called dose escalation.

Intervention / Treatment
Drug: S241656

Participants will take the study drug, S241656, as capsules or tablets by mouth. The drug will be taken during periods called “cycles”. One cycle lasts 28 days. Some participants will also receive other cancer treatments, like chemotherapy, along with the study drug. If participants receive chemotherapy, it will be given through a drip into a vein.

Participant Group / Arm
Experimental: Part 2: Dose Optimization and Dose Expansion

Groups of participants will receive the best doses of the study drug(s) to better determine the safety and effectiveness of S241656 alone or in combination with other anti-cancer treatments. This part is called dose optimization and dose expansion.

Intervention / Treatment
Drug: S241656

Participants will take the study drug, S241656, as capsules or tablets by mouth. The drug will be taken during periods called “cycles”. One cycle lasts 28 days. Some participants will also receive other cancer treatments, like chemotherapy, along with the study drug. If participants receive chemotherapy, it will be given through a drip into a vein.

Keywords

Provided by Servier
BRAF Class I BRAF Class II BRAF Class III KRAS Intolerant histiocytic neoplasm BDTX-4933 Phase 1 dose escalation dose expansion MAPK mitogen-activated protein kinase RAS RAF Upstream oncogenic alterations RAF inhibitor intracranial disease CRAF NRAS RAF fusions
Additional Relevant MeSH Terms Glioma
Carcinoma, Non-Small-Cell Lung Histiocytosis Lung Neoplasms Thyroid Neoplasms Colorectal Neoplasms Brain Neoplasms