[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100499720":3},{"organization":4,"armGroups":7,"interventions":74,"overallOfficials":86,"centralContacts":102,"locations":108,"responsibleParty":433,"collaborators":86,"id":435,"slug":436,"hasResults":437,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":86,"eligibilityCriteria":441,"healthyVolunteers":437,"sex":442,"minAge":443,"maxAge":86,"enrollmentInfo":444,"targetDuration":86,"studyType":447,"phases":448,"briefSummary":451,"conditions":452,"keywords":485,"overallStatus":111,"whyStopped":86,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":515},{"fullName":5,"class":6},"Servier","INDUSTRY",[8,14,18,24,32,35,39,43,46,50,54,57,60,63,67,70],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1A: Dose Escalation NSCLC","EXPERIMENTAL","S241656 will be administered as a monotherapy at escalating dose levels until the biologically effective dose (BED) range is determined.",[13],"Drug: S241656",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 1B: Dose Escalation GI Tumors","S241656 will be administered as a monotherapy at escalating dose levels until the BED range is determined.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part 1C: Dose Escalation PDAC","S241656 will be administered in combination with gemcitabine\u002Fnab-paclitaxel at escalating dose levels until the BED range is determined.",[13,22,23],"Drug: Gemcitabine","Drug: Nab-paclitaxel",{"label":25,"type":10,"description":26,"interventionNames":27},"Part 1D: Dose Escalation CRC","S241656 will be administered in combination with FOLFOX6\u002FFOLFOX7 or FOLFIRI, and panitumumab or cetuximab at escalating dose levels until the BED range is determined.",[13,28,29,30,31],"Drug: FOLFOX6\u002FFOLFOX7","Drug: FOLFIRI","Drug: Cetuximab","Drug: Panitumumab",{"label":33,"type":10,"description":16,"interventionNames":34},"Part 1E: Dose Escalation Other Solid Tumors",[13],{"label":36,"type":10,"description":37,"interventionNames":38},"Part 2A: Dose Optimization NSCLC","S241656 will be administered to further characterize the optimal dose.",[13],{"label":40,"type":10,"description":41,"interventionNames":42},"Part 2A1: Dose Expansion NSCLC with KRAS non-G12C mutations","S241656 will be administered as a monotherapy in the BED range.",[13],{"label":44,"type":10,"description":41,"interventionNames":45},"Part 2A2: Dose Expansion NSCLC with BRAF mutations",[13],{"label":47,"type":10,"description":48,"interventionNames":49},"Part 2A3: Dose Expansion NSCLC with KRAS non-G12C or BRAF mutations\u002Falterations","S241656 will be administered as a monotherapy in the BED range. Participants must also have active CNS metastatic disease",[13],{"label":51,"type":10,"description":52,"interventionNames":53},"Part 2A4: Dose Expansion NSCLC with a KRAS G12C mutation","S241656 will be administered as a monotherapy in the BED range. Participants must have received and progressed upon G12C targeted therapy",[13],{"label":55,"type":10,"description":41,"interventionNames":56},"Part 2B1: Dose Expansion PDAC",[13],{"label":58,"type":10,"description":41,"interventionNames":59},"Part 2B2: Dose Expansion CRC",[13],{"label":61,"type":10,"description":41,"interventionNames":62},"Part 2B3: Dose Expansion BTC",[13],{"label":64,"type":10,"description":65,"interventionNames":66},"Part 2C1: Dose Expansion PDAC","S241656 will be administered in combination with anti-cancer therapies in the BED range. The combination therapies to be used will be determined in the future.",[13],{"label":68,"type":10,"description":65,"interventionNames":69},"Part 2D1: Dose Expansion CRC",[13],{"label":71,"type":10,"description":72,"interventionNames":73},"Part 2F: Exploratory Food Effect","S241656 will be administered as a monotherapy.",[13],[75,82,87,90,93,96,99],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":80},"DRUG","S241656","RAF inhibitor targeting all classes of oncogenic BRAF alterations (Classes I, II, and III) and constitutively active CRAF, KRAS or NRAS mutations",[9,15,19,25,33,40,44,47,51,36,55,58,61,64,68,71],[81],"BDTX-4933",{"type":76,"name":83,"description":84,"armGroupLabels":85,"otherNames":86},"FOLFOX6\u002FFOLFOX7","Used as a combination therapy and administered 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Cancer Center","RECRUITING","Gilbert","Arizona","85234","United States","US",{"type":118,"coordinates":119},"Point",[120,121],-111.78903,33.35283,{"lat":121,"lon":120},[124,128],{"name":125,"role":105,"phone":126,"phoneExt":86,"email":127},"Brandi Luzania","480-256-5488","Brandi.Luzania@bannerhealth.com",{"name":129,"role":130,"phone":86,"phoneExt":86,"email":86},"Jiaxin Niu, MD","PRINCIPAL_INVESTIGATOR",{"facility":132,"status":111,"city":133,"state":134,"zip":135,"country":115,"countryCode":116,"cosmosGeoPoint":136,"geoPoint":140,"contacts":86},"The Angeles clinic - A cedars SINAI AFFILIATE","Los Angeles","California","90025",{"type":118,"coordinates":137},[138,139],-118.24368,34.05223,{"lat":139,"lon":138},{"facility":142,"status":111,"city":133,"state":134,"zip":143,"country":115,"countryCode":116,"cosmosGeoPoint":144,"geoPoint":146,"contacts":86},"USC Norris Comprehensive Cancer Center","90033",{"type":118,"coordinates":145},[138,139],{"lat":139,"lon":138},{"facility":148,"status":111,"city":149,"state":134,"zip":150,"country":115,"countryCode":116,"cosmosGeoPoint":151,"geoPoint":155,"contacts":86},"University of California, San Francisco (UCSF)","San Francisco","94143",{"type":118,"coordinates":152},[153,154],-122.41942,37.77493,{"lat":154,"lon":153},{"facility":157,"status":158,"city":159,"state":160,"zip":161,"country":115,"countryCode":116,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"University of Colorado - Aurora Cancer Center","NOT_YET_RECRUITING","Aurora","Colorado","80045",{"type":118,"coordinates":163},[164,165],-104.83192,39.72943,{"lat":165,"lon":164},[168],{"name":169,"role":105,"phone":170,"phoneExt":86,"email":171},"Halle Kuykendall","720-848-0356","halle.kuykendall@cuanschutz.edu",{"facility":173,"status":111,"city":174,"state":175,"zip":176,"country":115,"countryCode":116,"cosmosGeoPoint":177,"geoPoint":181,"contacts":86},"Yale University School of Medicine - Yale Cancer Center","New Haven","Connecticut","06520-8028",{"type":118,"coordinates":178},[179,180],-72.92816,41.30815,{"lat":180,"lon":179},{"facility":183,"status":158,"city":184,"state":185,"zip":186,"country":115,"countryCode":116,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"Georgetown University Lombardi Cancer Center","Washington D.C.","District of Columbia","20007",{"type":118,"coordinates":188},[189,190],-77.03637,38.89511,{"lat":190,"lon":189},[193,196],{"name":86,"role":105,"phone":194,"phoneExt":86,"email":195},"202-444-2223","Chul.Kim@gunet.georgetown.edu",{"name":197,"role":130,"phone":86,"phoneExt":86,"email":86},"Chul Kim, MD",{"facility":199,"status":111,"city":200,"state":201,"zip":202,"country":115,"countryCode":116,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Dana-Farber Cancer 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Blakeman","616-954-5551","jade.blakeman@startmidwest.com",{"facility":232,"status":111,"city":233,"state":234,"zip":235,"country":115,"countryCode":116,"cosmosGeoPoint":236,"geoPoint":240,"contacts":241},"Masonic Cancer Center University of Minnesota","Minneapolis","Minnesota","55455",{"type":118,"coordinates":237},[238,239],-93.26384,44.97997,{"lat":239,"lon":238},[242,246],{"name":243,"role":105,"phone":244,"phoneExt":86,"email":245},"Amit Kulkarni, MBBS","612-624-0123","kulkarni@umn.edu",{"name":247,"role":105,"phone":86,"phoneExt":86,"email":248},"Sara Crane","crane202@umn.edu",{"facility":250,"status":111,"city":251,"state":252,"zip":253,"country":115,"countryCode":116,"cosmosGeoPoint":254,"geoPoint":258,"contacts":259},"Washington University","St Louis","Missouri","63130",{"type":118,"coordinates":255},[256,257],-90.19789,38.62727,{"lat":257,"lon":256},[260],{"name":261,"role":105,"phone":262,"phoneExt":86,"email":263},"Medical Oncology Clinical Call Center","314-747-1171","MedicalOncologyClinicalCallCenter@dom.wustl.edu",{"facility":265,"status":111,"city":266,"state":266,"zip":267,"country":115,"countryCode":116,"cosmosGeoPoint":268,"geoPoint":272,"contacts":86},"NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)","New York","10016",{"type":118,"coordinates":269},[270,271],-74.00597,40.71427,{"lat":271,"lon":270},{"facility":274,"status":111,"city":266,"state":266,"zip":275,"country":115,"countryCode":116,"cosmosGeoPoint":276,"geoPoint":278,"contacts":279},"Memorial Sloan Kettering Cancer Center","10065",{"type":118,"coordinates":277},[270,271],{"lat":271,"lon":270},[280,282],{"name":281,"role":105,"phone":86,"phoneExt":86,"email":86},"Michael Offin, MD",{"name":86,"role":105,"phone":283,"phoneExt":86,"email":86},"646-608-3763",{"facility":285,"status":111,"city":286,"state":287,"zip":288,"country":115,"countryCode":116,"cosmosGeoPoint":289,"geoPoint":293,"contacts":86},"Duke University School of Medicine","Durham","North Carolina","27710",{"type":118,"coordinates":290},[291,292],-78.89862,35.99403,{"lat":292,"lon":291},{"facility":295,"status":111,"city":296,"state":297,"zip":298,"country":115,"countryCode":116,"cosmosGeoPoint":299,"geoPoint":303,"contacts":86},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":118,"coordinates":300},[301,302],-81.69541,41.4995,{"lat":302,"lon":301},{"facility":305,"status":111,"city":306,"state":307,"zip":308,"country":115,"countryCode":116,"cosmosGeoPoint":309,"geoPoint":313,"contacts":86},"Sarah Canon Research Institute (SCRI) Oncology Partners","Nashville","Tennessee","37203",{"type":118,"coordinates":310},[311,312],-86.78444,36.16589,{"lat":312,"lon":311},{"facility":315,"status":111,"city":316,"state":317,"zip":318,"country":115,"countryCode":116,"cosmosGeoPoint":319,"geoPoint":323,"contacts":86},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":118,"coordinates":320},[321,322],-95.36327,29.76328,{"lat":322,"lon":321},{"facility":325,"status":111,"city":326,"state":317,"zip":327,"country":115,"countryCode":116,"cosmosGeoPoint":328,"geoPoint":332,"contacts":86},"START San Antonio","San Antonio","78229",{"type":118,"coordinates":329},[330,331],-98.49363,29.42412,{"lat":331,"lon":330},{"facility":334,"status":111,"city":335,"state":336,"zip":337,"country":115,"countryCode":116,"cosmosGeoPoint":338,"geoPoint":342,"contacts":343},"NEXT Virginia","Fairfax","Virginia","22031",{"type":118,"coordinates":339},[340,341],-77.30637,38.84622,{"lat":341,"lon":340},[344],{"name":345,"role":105,"phone":346,"phoneExt":86,"email":347},"Blake Patterson","703-783-4505","bpatterson@nextoncology.com",{"facility":349,"status":111,"city":350,"state":351,"zip":352,"country":115,"countryCode":116,"cosmosGeoPoint":353,"geoPoint":357,"contacts":358},"Fred Hutchinson Cancer Research Center","Seattle","Washington","98109",{"type":118,"coordinates":354},[355,356],-122.33207,47.60621,{"lat":356,"lon":355},[359],{"name":360,"role":105,"phone":361,"phoneExt":86,"email":362},"Rebecca Wood","206-606-6970","rwood1@seattlecca.org",{"facility":364,"status":111,"city":365,"state":86,"zip":366,"country":367,"countryCode":368,"cosmosGeoPoint":369,"geoPoint":373,"contacts":86},"Center for Cancer and Organ Diseases - Rigshospitalet","Copenhagen","2100","Denmark","DK",{"type":118,"coordinates":370},[371,372],12.56553,55.67594,{"lat":372,"lon":371},{"facility":375,"status":111,"city":376,"state":86,"zip":86,"country":376,"countryCode":377,"cosmosGeoPoint":378,"geoPoint":382,"contacts":86},"Queen Mary Hospital","Hong Kong","HK",{"type":118,"coordinates":379},[380,381],114.17469,22.27832,{"lat":381,"lon":380},{"facility":384,"status":111,"city":385,"state":86,"zip":386,"country":387,"countryCode":388,"cosmosGeoPoint":389,"geoPoint":393,"contacts":86},"Kyoto University Hospital","Kyoto","606-8507","Japan","JP",{"type":118,"coordinates":390},[391,392],135.75385,35.02107,{"lat":392,"lon":391},{"facility":395,"status":111,"city":396,"state":86,"zip":397,"country":387,"countryCode":388,"cosmosGeoPoint":398,"geoPoint":402,"contacts":403},"National Cancer Center Hospital","Tokyo","104-0045",{"type":118,"coordinates":399},[400,401],139.69171,35.6895,{"lat":401,"lon":400},[404],{"name":405,"role":105,"phone":406,"phoneExt":86,"email":86},"Takafumi Koyama","+81-3-3542-2511",{"facility":408,"status":111,"city":409,"state":86,"zip":410,"country":411,"countryCode":412,"cosmosGeoPoint":413,"geoPoint":417,"contacts":86},"University College London Hospital","London","NW1 2PG","United Kingdom","UK",{"type":118,"coordinates":414},[415,416],-0.12574,51.50853,{"lat":416,"lon":415},{"facility":419,"status":111,"city":409,"state":86,"zip":420,"country":411,"countryCode":412,"cosmosGeoPoint":421,"geoPoint":423,"contacts":86},"Hammersmith Hospital","W12 0HS",{"type":118,"coordinates":422},[415,416],{"lat":416,"lon":415},{"facility":425,"status":111,"city":426,"state":86,"zip":427,"country":411,"countryCode":412,"cosmosGeoPoint":428,"geoPoint":432,"contacts":86},"The Christie NHS Foundation Trust","Manchester","M20 4BX",{"type":118,"coordinates":429},[430,431],-2.23743,53.48095,{"lat":431,"lon":430},{"type":434,"investigatorFullName":86,"investigatorTitle":86,"investigatorAffiliation":86,"oldNameTitle":86,"oldOrganization":86},"SPONSOR","100499720","phase-1-phase-12-trial-of-s241656-in-selected-rasmapk-mutation--positive-malignancies-100499720",false,"NCT05786924","Phase 1\u002F2 Trial of S241656 in Selected RAS\u002FMAPK Mutation- Positive Malignancies","A Phase 1\u002F2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With KRAS, BRAF and Other Selected RAS\u002FMAPK Mutation-Positive Malignancies","Key Inclusion Criteria:\n\n* Life expectancy of ≥ 12 weeks in the opinion of the investigator.\n* Histologically or cytologically confirmed recurrent locally advanced (unresectable) or metastatic solid tumors with documented RAS or RAF mutations or alterations.\n* Adequate bone marrow and organ function.\n* Recovered from toxicity to prior anti-cancer therapy.\n\nPart 1 Dose Escalation cohort ONLY:\n\n* Part 1A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C, HRAS, NRAS, BRAF or CRAF (RAF1) mutations or alterations\n* Part 1B: Advanced\u002Fmetastatic GI tumors (e.g., PDAC, CRC, and BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1C: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1D: Colorectal adenocarcinoma with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1E: Other advanced\u002Fmetastatic non-GI, non-NSCLC solid tumors with KRAS, HRAS, NRAS, BRAF, CRAF (RAF1) mutations or alterations\n\nPart 2 Dose Optimization and Expansion cohorts ONLY:\n\n* Part 2A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations and\u002For BRAF mutations\n* Part 2A1: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations\n* Part 2A2: Advanced\u002Fmetastatic NSCLC with BRAF mutations\n* Part 2A3: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C or BRAF mutations or alterations and active CNS metastatic disease\n* Part 2A4: Advanced\u002Fmetastatic NSCLC with a KRAS G12C mutation\n* Part 2B1: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B2: Advanced\u002Fmetastatic CRC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B3: Advanced\u002Fmetastatic BTC (adenocarcinoma) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n\nKey Exclusion Criteria:\n\n* Cancer that has a known MEK1\u002F2 mutation.\n* Known allergy\u002Fhypersensitivity to excipients of S241656 or to any of the registered IMPs administered in combination.\n* Any contra-indication, to use of any of the combination chemotherapy or anti-EGFR therapy partners administered as part of this trial.\n* Major surgery within 4 weeks of study entry or planned during study.\n* Ongoing anticancer therapy.\n* Ongoing radiation therapy.\n* Uncontrolled or active clinically relevant bacterial, fungal, or specific viral infection requiring systemic therapy.\n* Clinically significant cardiovascular disease.\n* Symptomatic spinal cord compression.\n* Evidence of active malignancy (other than study-specific malignancies) requiring systemic therapy within the next 2 years.\n* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.\n* Females who are pregnant or breastfeeding.\n* Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.\n* Prior use of experimental agents that target the KRAS\u002FBRAF\u002FMEK\u002FERK pathway.","ALL","18 Years",{"count":445,"type":446},554,"ESTIMATED","INTERVENTIONAL",[449,450],"PHASE1","PHASE2","BDTX-4933-101 is a first-in-human, open-label, Phase 1\u002F2 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\u002Fmetastatic non-small cell lung cancer (NSCLC), Gastrointestinal (GI) cancers, and other solid tumors harboring KRAS, HRAS, NRAS, BRAF, and\u002For 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\u002Fmetastatic NSCLC with KRAS and\u002For BRAF mutations, and with Pancreatic Ductal AdenoCarcinoma (PDAC), ColoRectal Cancer (CRC), and Biliary Tract Cancer (BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For 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.",[453,454,455,456,457,458,459,460,461,462,463,464,465,466,467,468,469,470,471,472,473,474,475,476,477,478,479,480,481,482,483,484],"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",[486,487,488,489,490,81,491,492,493,494,495,496,497,498,499,500,501,502,503],"BRAF Class I","BRAF Class II","BRAF Class III","KRAS","Intolerant histiocytic neoplasm","Phase 1","dose escalation","dose expansion","MAPK","mitogen-activated protein kinase","RAS","RAF","Upstream oncogenic alterations","RAF inhibitor","intracranial disease","CRAF","NRAS","RAF fusions","2026-06-16",{"date":506,"type":507},"2026-06-17","ACTUAL",{"date":509,"type":507},"2023-04-18",{"date":511,"type":446},"2028-06",{"name":513,"class":514},"Institut de Recherches Internationales Servier","OTHER",27]