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Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies
NCT05786924 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Cetuximab
- DRUG FOLFIRI
- DRUG Panitumumab
- DRUG S241656
- DRUG FOLFOX6/FOLFOX7
Study Locations (10)
Arizona
- Banner Health- MD Anderson Cancer Center — Gilbert
Colorado
- University of Colorado - Aurora Cancer Center — Aurora
District of Columbia
- Georgetown University Lombardi Cancer Center — Washington D.C.
Massachusetts
- Dana-Farber Cancer Institute — Boston
Michigan
- South Texas Accelerated Research Therapeutics (START) Midwest — Grand Rapids
Minnesota
- Masonic Cancer Center University of Minnesota — Minneapolis
Missouri
- Washington University — St Louis
New York
- Memorial Sloan Kettering Cancer Center — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 554 participants |
| Start Date | 2023-04-18 |
| Est. Completion | 2028-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05786924
The ClinicalTrials.gov registry entry for NCT05786924 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 554 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Institut de Recherches Internationales Servier, which has 16 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions — of which Cetuximab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05786924 reports 10 study locations spanning 10 distinct geographic areas — top geographies include Arizona, Colorado, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05786924 about?
NCT05786924 is a clinical study titled "Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies". 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 stud...
What is the current status of trial NCT05786924?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 554 participants. The study started on 2023-04-18. Estimated completion is 2028-06.
What conditions does trial NCT05786924 study?
This clinical trial studies the following conditions: Non-small Cell Lung Cancer, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Lung Cancer, Histiocytosis, BRAF Gene Mutation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05786924?
The interventions under investigation include: Cetuximab (DRUG), FOLFIRI (DRUG), Panitumumab (DRUG), S241656 (DRUG), FOLFOX6/FOLFOX7 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05786924?
This trial is sponsored by Institut de Recherches Internationales Servier, which has 16 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05786924 being conducted?
This trial has 10 study locations across Arizona, Colorado, District of Columbia, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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