[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"braf-mutation-related-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:braf-mutation-related-tumors":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,92],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":59,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"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":19,"type":20},554,"ESTIMATED","INTERVENTIONAL",[23,24],"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.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58],"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",[60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78],"BRAF Class I","BRAF Class II","BRAF Class III","KRAS","Intolerant histiocytic neoplasm","BDTX-4933","Phase 1","dose escalation","dose expansion","MAPK","mitogen-activated protein kinase","RAS","RAF","Upstream oncogenic alterations","RAF inhibitor","intracranial disease","CRAF","NRAS","RAF fusions","RECRUITING","2026-06-16",{"date":82,"type":83},"2026-06-17","ACTUAL",{"date":85,"type":83},"2023-04-18",{"date":87,"type":20},"2028-06",{"name":89,"class":90},"Institut de Recherches Internationales Servier","OTHER",27,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":21,"phases":102,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":5},"100585439","phase-1-xl092-and-cemiplimab-in-braf-wt-thyroid-cancer-100585439","NCT06902376","XL092 and Cemiplimab in BRAF WT Thyroid Cancer","NEO-COMBAT XL: Neoadjuvant and Maintenance XL092 and Cemiplimab in BRAF V600E-wildtype Anaplastic Thyroid Cancer: a Phase 1B Study","NEO-COMBATXL","Inclusion Criteria:\n\n* Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.\n* Subjects are willing and able to comply with study procedures based on the judgment of the investigator.\n* Age ≥ 18 years at the time of consent.\n* the Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.\n* Pathologic findings supporting the clinical impression of anaplastic thyroid cancer. Terminology consistent or suggestive of diagnosis may include the following: anaplastic thyroid carcinoma, undifferentiated carcinoma, squamous carcinoma; carcinoma with spindled, giant cell, or epithelial features; poorly differentiated carcinoma with pleomorphism, extensive necrosis with tumor cells present.\n* Subject is willing to have a fresh biopsy at least 3 days prior to neoadjuvant therapy if archival tissue is unavailable. Also willing to have a biopsy at the time of SOC surgery, if applicable.\n* Must have BRAF V600E mutation-negative tumor, as determined by BRAF V600E immunohistochemistry on tumor tissue or genetic\u002Fmolecular testing of the tumor.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding (Note: breast milk cannot be stored for future use while the mother is being treated on the study). Females should not breastfeed while receiving study treatment and for 1 month from the last dose of XL092.\n* Patients who have had prior exposure to any immune modulating agents or any type of small molecule kinase inhibitor (including investigational agents) and have documented disease progression on these agents will not be eligible.\n* Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments (i.e., with use of disease modifying agents, corticosteroids (\\>10 mg of prednisone or equivalent) or immunosuppressive drugs) which may suggest risk of immune-mediated Adverse Events.\n* Replacement therapy (e.g.: thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment.\n* Subject history of documented allergic reactions or acute hypersensitivity reactions attributed to antibody treatments.\n* Subject is receiving prohibited medications or treatments as listed in the protocol that cannot be discontinued\u002Freplaced by an alternative therapy within 7 days of initiating treatment.\n* Participation in another clinical study with an investigational product during the last 3 weeks.",{"count":101,"type":20},12,[23],"This multicenter study examines the safety and feasibility of the combination of neoadjuvant XL092 and cemiplimab prior to surgical resection in participants with wild-type (WT) anaplastic thyroid cancer (ATC) that has a BRAF mutation (BRAF V600E).",[105,46,33],"Anaplastic Thyroid Cancer",[107,108,109,110,111,112,113],"neoadjuvant chemotherapy","neoadjuvant immunotherapy","standard of care","BRAF V600E-WT ATC","XL092","cemiplimab","receptor tyrosine kinase inhibitor","2025-11-03",{"date":116,"type":83},"2025-11-05",{"date":118,"type":83},"2025-06-03",{"date":120,"type":20},"2028-08-31",{"name":122,"class":90},"UNC Lineberger Comprehensive Cancer Center"]