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NCT05786924 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies
A Phase 1 study of Non-Small Cell Lung Cancer and Metastatic Lung Non-Small Cell Carcinoma, sponsored by Institut de Recherches Internationales Servier.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 554
- Enrollment target
- 10
- Study locations
NCT05786924: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and Metastatic Lung Non-Small Cell Carcinoma, sponsored by Institut de Recherches Internationales Servier.
NCT05786924 is a Phase 1 study of Non-Small Cell Lung Cancer and Metastatic Lung Non-Small Cell Carcinoma that is actively recruiting participants, run by Institut de Recherches Internationales Servier. The registered enrollment target is 554 participants, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (15% lower). The trial reports 10 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05786924, a Phase 1 study of Non-Small Cell Lung Cancer and Metastatic Lung Non-Small Cell Carcinoma, is actively recruiting participants, sponsored by Institut de Recherches Internationales Servier.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 554 participants
- Enrollment target
- 10
- Study locations
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.
Primary Outcome
A DLT is defined as any event meeting the DLT criteria occurring within the first 28-day cycle
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 |
What NCT05786924 shows while recruiting
NCT05786924 is an interventional study that assigns participants to a tested intervention. The registered 554 participants enrollment target is mid-sized for trials with a published cap, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (15% lower).
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.
NCT05786924 lists 10 locations in 10 states (Arizona, Colorado, District of Columbia).
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.
What interventions are being tested in trial NCT05786924?
The interventions under investigation include: Cetuximab (DRUG), FOLFIRI (DRUG), Panitumumab (DRUG), S241656 (DRUG), FOLFOX6/FOLFOX7 (DRUG).
Who is sponsoring clinical trial NCT05786924?
This trial is sponsored by Institut de Recherches Internationales Servier, which has 27 total clinical trials registered on ClinicalTrials.gov.
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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Where NCT05786924's enrollment target sits among peer trials
554 65th of 454 higher than 390 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
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