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Clinical Trials in China / NCT05786924
Recruiting Phase 1/2

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

NCT05786924 · tracked via the Priya Life Science China tracker
Sponsor
Institut de Recherches Internationales Servier
Phase
Phase 1/2
Started
2023-04-18
Last updated
2026-09-16

Condition(s) studied

Non-small Cell Lung CancerHistiocytic NeoplasmHistiocytosisBRAF Gene MutationBRAF V600EBRAF V600 MutationBRAF Mutation-Related TumorsBRAFMetastatic Lung Non-Small Cell CarcinomaMetastatic Lung CancerRecurrent Lung CancerRecurrent Lung Non-Small Cell CarcinomaNSCLCSolid TumorSolid CarcinomaKRAS G12DKRAS G12VKRAS Mutation-Related TumorsNRAS Gene MutationThyroid CancerThyroid CarcinomaColorectal CancerColorectal CarcinomaRecurrent Histiocytic and Dendritic Cell NeoplasmBrain MetastasesRecurrent NSCLCKRAS G13CAcquired Resistance to KRAS G12C InhibitorKRAS G12AKRAS G12FKRAS G12RKRAS G13D

Investigational drug(s) / intervention(s)

S241656FOLFOX6/FOLFOX7FOLFIRICetuximabPanitumumabGemcitabineNab-paclitaxel

S241656: RAF inhibitor targeting all classes of oncogenic BRAF alterations (Classes I, II, and III) and constitutively active CRAF, KRAS or NRAS mutations

FOLFOX6/FOLFOX7: Used as a combination therapy and administered intravenously

FOLFIRI: Used as a combination therapy and administered intravenously

Cetuximab: Used as a combination therapy and administered intravenously

Panitumumab: Used as a combination therapy and administered intravenously

Gemcitabine: Used as a combination therapy and administered intravenously

Nab-paclitaxel: Used as a combination therapy and administered intravenously

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: * 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 1 Dose Escalation cohort ONLY: * 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 2 Dose Optimization and Expansion cohorts ONLY: * 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 Key Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (49)

FacilityCityRegionStatus
Banner Health- MD Anderson Cancer Center Gilbert Arizona Recruiting
The Angeles clinic - A cedars SINAI AFFILIATE Los Angeles California Recruiting
USC Norris Comprehensive Cancer Center Los Angeles California Recruiting
University of California, San Francisco (UCSF) San Francisco California Recruiting
University of Colorado - Aurora Cancer Center Aurora Colorado Not Yet Recruiting
Yale University School of Medicine - Yale Cancer Center New Haven Connecticut Recruiting
Georgetown University Lombardi Cancer Center Washington D.C. District of Columbia Not Yet Recruiting
Sibley Memorial Hospital Washington D.C. District of Columbia Not Yet Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
South Texas Accelerated Research Therapeutics (START) Midwest Grand Rapids Michigan Recruiting
Masonic Cancer Center University of Minnesota Minneapolis Minnesota Recruiting
Washington University St Louis Missouri Recruiting
NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute) New York New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Duke University School of Medicine Durham North Carolina Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
Sarah Canon Research Institute (SCRI) Oncology Partners Nashville Tennessee Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
START San Antonio San Antonio Texas Recruiting
NEXT Virginia Fairfax Virginia Recruiting
Fred Hutchinson Cancer Research Center Seattle Washington Recruiting
Peter MacCallum Cancer Centre East Melbourne Australia Not Yet Recruiting
Westmead Hospital Westmead Australia Not Yet Recruiting
Beijing Cancer Hospital Beijing China Recruiting
Shandong Cancer Hospital (Cancer Hospital of Shandong First Medical University) Jinan China Not Yet Recruiting
Fudan University Zhongshan Hospital Shanghai China Not Yet Recruiting
The Second Affiliated Hospital of Soochow University Suzhou China Recruiting
Center for Cancer and Organ Diseases - Rigshospitalet Copenhagen Denmark Recruiting
Centre Georges Francois Leclerc Dijon France Not Yet Recruiting
Institut Curie Paris France Not Yet Recruiting
AP-HP Hopital Europeen Georges Pompidou Paris France Not Yet Recruiting
Centre Eugene Marquis Rennes France Not Yet Recruiting
Institut Gustave Roussy Villejuif France Not Yet Recruiting
Queen Mary Hospital Hong Kong Hong Kong Recruiting
Prince of Wales Shatin Hong Kong Recruiting
Istituto Europeo di Oncologia Milan Italy Not Yet Recruiting
IFO - Istituto Nazionale dei Tumori Regina Elena Rome Italy Not Yet Recruiting
Istituto Clinico Humanitas Rozzano Italy Not Yet Recruiting
Kanagawa Cancer Center Kanagawa Japan Recruiting
Kyoto University Hospital Kyoto Japan Recruiting

+ 9 more sites — see the full list on the official registry below.

More Institut de Recherches Internationales Servier trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05786924 on ClinicalTrials.gov ↗ ← All trials in China