[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mek-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mek-mutation":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":17,"phases":4,"briefSummary":18,"conditions":19,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":46,"locationsCount":49},"100405976","expanded-access-to-ulixertinib-bvd-523-in-patients-with-advanced-mapk-pathway-altered-malignancies-100405976",false,"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.","ALL","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.",[20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Pancreatic Cancer","Small Bowel Cancer","Colorectal Cancer","Melanoma","Non Small Cell Lung Cancer","Thyroid Cancer","Bladder Cancer","Head and Neck Cancer","Gastric Cancer","Esophageal Cancer","Cholangiocarcinoma","Ovarian Cancer","Hepatocellular Carcinoma","Glioblastoma","MAPK Gene Mutation","KRAS Activating Mutation","BRAF Gene Mutation","NRAS Gene Mutation","HRAS Gene Mutation","MEK Mutation","ERK Mutation","AVAILABLE","2026-06-02",{"date":44,"type":45},"2026-06-04","ACTUAL",{"name":47,"class":48},"xCures","INDUSTRY",26,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":15,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":74,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":89},"100541173","phase-1-a-study-to-investigate-the-safety-and-efficacy-of-nst-628-oral-tablets-in-subjects-with-solid-tumors-100541173","NCT06326411","A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors","A Phase I, Open Label Single-arm Two-part Study to Investigate Safety, Pharmacokinetics, and Preliminary Efficacy of Pan-RAF\u002FMEK Glue NST-628 Oral Tablets in Subject With Solid Tumors Harboring Genetic Alterations in the MAPK Pathway and With Other Solid Tumors","NST-628","Inclusion Criteria:\n\nSubjects are eligible to be included in the study only if all of the following criteria apply:\n\n1. Subjects must be ≥18 years old (or of legal age of consent in the country in which the study is taking place) at the time of signing the informed consent.\n2. Subjects who have a histologically or cytologically documented metastatic or locally advanced solid tumor, for which standard of care (SoC) therapy does not exist, no longer provides benefit, or is not tolerated by the subject, or the subject has been assessed by the Investigator as not being suitable for SoC therapy.\n\n   1. Part A: Subjects with any solid tumor with genetic alteration of or evidence of tumor dependence upon the RAS\u002FMAPK pathway (subject to additional restrictions specified in the study protocol)\n   2. Part B: Subjects must be diagnosed with one of the following solid tumors harboring specified genetic alterations based on a validated local test:\n\n   i. Melanoma Cohorts:\n   1. Activating NRAS mutations\n   2. Select BRAF alterations\n\n   ii. Non-Melanoma Cohorts:\n   1. Solid tumors with NRAS activating mutations\n   2. Solid tumors with KRAS activating mutations\n   3. Solid tumors with select BRAF alterations\n   4. Glioma with BRAF alterations\n3. Newly obtained or archived tumor tissue is required\n4. Part B: measurable disease as defined by RECIST Version 1.1 or by other disease assessment tool standard for a given tumor type (if RECIST v. 1.1 is not standard)\n5. Performance status\n\n   1. Solid tumors other than glioma: ECOG 0 or 1\n   2. Glioma: Karnofsky ≥ 70 and ECOG 0 or 1\n6. Have adequate organ function\n7. Understand and voluntarily sign an Institutional Review Board\u002FIndependent Ethics Committee-approved informed consent form prior to any study-specific evaluation.\n8. Life expectancy ≥ 12 weeks\n\nExclusion Criteria:\n\nSubjects are excluded from the study if any of the following criteria apply:\n\n1. Conditions interfering with oral intake of NST-628\n2. Conditions interfering with intestinal absorption of an orally administered drug\n3. A history or current evidence of significant retinal pathology leading to increased risk of RVO\n4. A history or evidence of cardiovascular risk\n5. Current or history within 6 months of planned Cycle 1 Day 1 of pneumonitis or interstitial lung disease (ILD)\n6. Part B: prior treatment with any MEK or BRAF inhibitor\n7. Untreated or symptomatic central nervous system (CNS) metastases\n8. Chemotherapy, radiation, gene therapy, vaccine therapy, or anti-cancer antibodies \u002F ADCs within 28 days of Cycle 1 Day 1\n9. Targeted small molecule agents within 14 days or 5 half-lives of Cycle 1 Day 1\n10. Females who are pregnant or breastfeeding.\n11. For fertile patients (female able to become pregnant or male able to father a child), refusal to use effective contraception during the period of the trial and for 6 months after the last dose of NST-628\n12. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study","18 Years",{"count":60,"type":61},230,"ESTIMATED","INTERVENTIONAL",[64],"PHASE1","This is a two-part Phase 1, open label, multi-center, single arm, non-randomized, multiple dose, safety, pharmacokinetic (PK) and preliminary efficacy study of single agent NST-628 in adult patients with MAPK pathway mutated\u002Fdependent advanced solid tumors who have exhausted standard treatment options.",[67,39,68,69,23,70,71,72,73],"Oncology","RAF Gene Mutation","Ras (KRAS or NRAS) Gene Mutation","NSCLC","Glioma","Solid Tumor, Adult","MAPK Pathway Gene Mutation",[75,76,77,78],"RAS","MEK","RAF","solid tumor","RECRUITING","2026-04-15",{"date":82,"type":45},"2026-04-20",{"date":84,"type":45},"2024-04-09",{"date":86,"type":61},"2029-11",{"name":88,"class":48},"Nested Therapeutics, Inc",23]