[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nras-gene-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nras-gene-mutation":45},{"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":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":98,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":123,"locationsCount":126},"100405976","expanded-access-to-ulixertinib-bvd-523-in-patients-with-advanced-mapk-pathway-altered-malignancies-100405976","NCT04566393","Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies","Inclusion Criteria:\n\n* Main Inclusion Criterion:\n\n  1\\. Patient has a MAPK pathway-altered solid tumor(s), including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK mutations.\n* Other Inclusion Criteria:\n\n  1. In the opinion of the treating physician, the patient has exhausted or has inadequate response to available anti-cancer treatments.\n  2. In the opinion of the treating physician, the patient has adequate organ function to tolerate ulixertinib as defined in section 6.1\n  3. Male or female patients aged ≥ 12 years.\n  4. Patient must be able to swallow and retain orally administered medication.\n\n     Note: Ulixertinib is primarily absorbed in the duodenum and therefore patients with any prior stomach or duodenal resection should be evaluated with that understanding.\n  5. For females, evidence of post-menopausal status or negative urinary or serum pregnancy test for pre-menopausal patients.\n  6. Highly effective contraception for both male and female patients throughout the treatment and for at least 4 months after last treatment administration. In patients under the age of 18, who are not sexually active, abstinence is an acceptable form.\n  7. Toxicities related to any prior treatments are either stable, stable on supportive therapy, resolved, or in the opinion of the treating physician, clinically non-significant\n  8. Ability to understand a written informed consent document, and the willingness to sign it. Assent will be obtained when appropriate based on the patient's age.\n\nExclusion Criteria:\n\n1. Patient is already participating in or qualifies for and is able to enroll in a clinical trial of ulixertinib (BVD-523).\n2. Patient has received systemic therapy with an investigational agent within 5 half-lives or 14 days prior to starting ulixertinib treatment, whichever is shorter.\n3. Patient has received radiotherapy within 14 days prior to the first dose of ulixertinib treatment other than for the allowable treatment of symptomatic bone metastasis.\n4. A history of current evidence\u002Frisk of retinal vein occlusion (RVO) or central serous retinopathy (CSR)\n5. Current evidence of uncontrolled, significant intercurrent illness that would, in the treating physician's judgment, contraindicate the patient's treatment with ulixertinib due to safety concerns.\n6. Patients who, in the opinion of the treating physician, have not fully recovered from recent major surgery to a sufficient extent to tolerate treatment with ulixertinib.\n7. Known hypersensitivity to ulixertinib or any component in its formulation.\n8. Patients taking prohibited medications as described in current Investigator's Brochure.\n\n   Note: Patients who require treatment with Drugs that are strong inhibitors or inducers of CYP1A2, CYP2D6, and CYP3A4 (see Appendix 3) were excluded from the FIH study of ulixertinib and should be discussed with xCures to review if any potential benefits outweigh the potential risks.\n9. Patient is actively breastfeeding.\n10. Prior stomach or duodenal resection that in the opinion of the treating physician would affect the breakdown and absorption of ulixertinib.","12 Years","EXPANDED_ACCESS","The objective of this expanded access program is to provide ulixertinib (BVD-523) for compassionate use in advanced cancer patients with MAPK pathway-altered solid tumor(s), including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK mutations who have incomplete response to or have exhausted available therapies.\n\nUlixertinib is available for treatment as monotherapy or in combination with other clinically tolerable agent(s), conditionally approved by the drug manufacturer.",[102,103,48,104,105,46,106,107,108,109,110,111,112,113,114,115,30,45,116,117,118],"Pancreatic Cancer","Small Bowel Cancer","Melanoma","Non Small Cell Lung Cancer","Bladder Cancer","Head and Neck Cancer","Gastric Cancer","Esophageal Cancer","Cholangiocarcinoma","Ovarian Cancer","Hepatocellular Carcinoma","Glioblastoma","MAPK Gene Mutation","KRAS Activating Mutation","HRAS Gene Mutation","MEK Mutation","ERK Mutation","AVAILABLE","2026-06-02",{"date":122,"type":83},"2026-06-04",{"name":124,"class":125},"xCures","INDUSTRY",26]