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Phase 1/2 Trial of S241656 for RAS/MAPK Mutation-Positive Cancers

This study is testing a new drug called S241656, alone or with other cancer treatments like FOLFOX6/FOLFOX7, FOLFIRI, Cetuximab, or Panitumumab. S241656 is designed to target specific changes (mutations) in genes like BRAF, KRAS, and NRAS, which are often found in certain cancers. The study is for adults with advanced solid tumors, including non-small cell lung cancer and histiocytic neoplasms, that have these specific gene mutations. Researchers are looking to see how safe S241656 is, what side effects it might cause, and how well it shrinks tumors. The study plans to enroll up to 554 participants. We don't have information on its current recruitment status.

Study design
This is a Phase 1/2 study, meaning it's an early-stage trial. It is an open-label study, so you and your doctors will know which treatment you are receiving. It aims to enroll up to 554 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects and tumor response through study completion, which is approximately 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05786924

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Institut de Recherches Internationales Servier
~554 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:S241656FOLFOX6/FOLFOX7FOLFIRICetuximabPanitumumabGemcitabine

At a glance

Recruiting sites
25 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Escalation: Incidence of dose-limiting toxicities (DLTs)
Measured over The first 28-day cycle (Cycle 1)
+2 more outcomes measured

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

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Where it's being run

27 sites across 20 states
California3
United Kingdom3
New York2
Texas2
Japan2
Arizona1
Colorado1
Connecticut1

Who to contact

Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
[email protected]
+33 1 55 72 60 00
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 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 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

Exclusion

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.

What this trial measures

  • Dose Escalation: Incidence of dose-limiting toxicities (DLTs)The first 28-day cycle (Cycle 1)

    A DLT is defined as any event meeting the DLT criteria occurring within the first 28-day cycle

  • Dose Escalation: Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)Through study completion, approximately 5 years
  • Dose Optimization/Expansion: Objective response (OR)Through study completion, approximately 5 years