OncoMatch/Clinical Trials/NCT05786924
Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies
Is NCT05786924 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments for non-small cell lung cancer.
Treatment: S241656 · FOLFOX6/FOLFOX7 · FOLFIRI · Cetuximab · Panitumumab · Gemcitabine · Nab-paclitaxel — BDTX-4933-101 is a first-in-human, open-label, Phase 1/2 dose escalation, dose optimization and expansion study designed to evaluate the safety and tolerability of S241656 as monotherapy and in combination with other anti-cancer therapies in participants with selected advanced malignancies. The study population for the Dose Escalation part of the study comprises adults with recurrent advanced/metastatic non-small cell lung cancer (NSCLC), Gastrointestinal (GI) cancers, and other solid tumors harboring KRAS, HRAS, NRAS, BRAF, and/or CRAF (Rapidly Accelerated Fibrosarcoma (RAF1)) mutations or alterations. A dose optimization part in adults with NSCLC may follow the dose escalation phase if the sponsor, in consultation with the safety review committee, decides it is necessary to further characterize the optimal dose. However, the study may also proceed directly to the expansion phase. The study population for the Dose Expansion part of the study comprises adults with advanced/metastatic NSCLC with KRAS and/or BRAF mutations, and with Pancreatic Ductal AdenoCarcinoma (PDAC), ColoRectal Cancer (CRC), and Biliary Tract Cancer (BTC) with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations and alterations. All patients will self-administer S241656 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Tumor Agnostic
Colorectal Cancer
Biomarker criteria
Required: KRAS mutation or alteration
KRAS mutations or alterations
Required: HRAS mutation or alteration
HRAS mutations or alterations
Required: NRAS mutation or alteration
NRAS mutations or alterations
Required: BRAF mutation or alteration
BRAF mutations or alterations
Required: RAF1 mutation or alteration
CRAF (RAF1) mutations or alterations
Required: KRAS non-G12C mutation
KRAS non-G12C mutations
Required: KRAS G12C
KRAS G12C mutation
Excluded: MEK1 mutation
Cancer that has a known MEK1/2 mutation
Excluded: MEK2 mutation
Cancer that has a known MEK1/2 mutation
Disease stage
Metastatic disease required
Prior therapy
Cannot have received: KRAS/BRAF/MEK/ERK pathway inhibitor
Prior use of experimental agents that target the KRAS/BRAF/MEK/ERK pathway
Lab requirements
Blood counts
Adequate bone marrow function
Kidney function
Adequate organ function
Liver function
Adequate organ function
Adequate bone marrow and organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Banner Health- MD Anderson Cancer Center · Gilbert, Arizona
- University of Colorado - Aurora Cancer Center · Aurora, Colorado
- Georgetown University Lombardi Cancer Center · Washington D.C., District of Columbia
- Dana-Farber Cancer Institute · Boston, Massachusetts
- South Texas Accelerated Research Therapeutics (START) Midwest · Grand Rapids, Michigan
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05786924 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior KRAS/BRAF/MEK/ERK pathway inhibitor disqualifies patients from enrollment.
Does this trial require KRAS?
Yes, KRAS mutation or alteration is a required biomarker for enrollment.
Does this trial require HRAS?
Yes, HRAS mutation or alteration is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS mutation or alteration is a required biomarker for enrollment.
Are patients with MEK1 alterations eligible?
No. MEK1 mutation is an exclusion criterion.
Are patients with MEK2 alterations eligible?
No. MEK2 mutation is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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