[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ras-kras-or-nras-gene-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ras-kras-or-nras-gene-mutation":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,54,97,124],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":36,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100541173","phase-1-a-study-to-investigate-the-safety-and-efficacy-of-nst-628-oral-tablets-in-subjects-with-solid-tumors-100541173",false,"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","ALL","18 Years",{"count":20,"type":21},230,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31,32,33,34,35],"Oncology","MEK Mutation","RAF Gene Mutation","Ras (KRAS or NRAS) Gene Mutation","Melanoma","NSCLC","Glioma","Solid Tumor, Adult","MAPK Pathway Gene Mutation",[37,38,39,40],"RAS","MEK","RAF","solid tumor","RECRUITING","2026-04-15",{"date":44,"type":45},"2026-04-20","ACTUAL",{"date":47,"type":45},"2024-04-09",{"date":49,"type":21},"2029-11",{"name":51,"class":52},"Nested Therapeutics, Inc","INDUSTRY",23,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":76,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":96},"100374121","canadian-cancers-with-rare-molecular-alterations-carma---basket-real-world-observational-study-bros-100374121","NCT04151342","CAnadian CAncers With Rare Molecular Alterations (CARMA) - Basket Real-world Observational Study (BROS)","CARMA-BROS","Inclusion Criteria:\n\n* Patients ≥ 18 years at cancer diagnosis\n* Diagnosed with malignant tumour(s) with molecular testing completed that identified rare molecular alterations\n* Accessible\u002Favailable molecular testing reports\u002Fdocumentation to confirm type(s) of molecular alteration(s) (resulting from the conduct of polymerase chain reaction \\[PCR\\] based next generation sequencing \\[NGS\\], immunohistochemistry \\[IHC\\], fluorescence in situ hybridization \\[FISH\\], liquid biopsy)\n* Canadian resident received follow-up for cancer care in Canada or is currently receiving\u002Fplanning follow-up for cancer care to occur in Canada at time of enrollment\n\nExclusion Criteria:\n\n* Previous refusal of the deceased patient, when living, to enroll in this study or patient approached for this study is unable to provide informed consent",{"count":62,"type":21},5500,"OBSERVATIONAL","This study will collect data on Canadian cancer patients that have uncommon\u002Frare changes in their tumours, such as alterations\u002Frearrangements in the genetic material inside cells - known as deoxyribonucleic acid, or DNA, which acts as a map and gives directions to the cells on how to make other substances the body needs - because some of these changes have been found to respond to different drugs that help to stop the cancer. These rare changes occur in genes such as but not limited to ALK, EGFR, ROS1, BRAF, and NTRK which have targeted drugs in a family known as tyrosine kinase inhibitors (TKIs), and KRAS G12C mutation, which now has a targeted inhibitor drug therapy for patients with non small cell lung cancer (NSCLC). The goals for the study are to compare the natural history of such cancers and the treatment outcomes, including toxicities and patient-reported outcomes, for the different therapies.",[66,67,68,69,70,71,72,73,74,75],"Cancer","Malignancies Multiple","Malignant Solid Tumor","Cancer, Therapy-Related","Molecular Sequence Variation","Genetic Alteration","Gene Fusion","Receptor Tyrosine Kinase Gene Mutation","RTK Family Gene Mutation","Ras (Kras or Nras) Gene Mutation",[77,78,79,80,81,82,83,84,85],"observational study","cancer","cancer therapies","molecular alterations","real-world evidence","real-world data","tyrosine kinase inhibitors","ambispective","ras GTPase inhibitors","2025-11-25",{"date":88,"type":45},"2025-12-03",{"date":90,"type":45},"2020-01-17",{"date":92,"type":21},"2029-12",{"name":94,"class":95},"University Health Network, Toronto","OTHER",27,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":106,"conditions":107,"keywords":113,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"100550662","comparison-of-molecular-genetic-concordance-of-the-primary-tumor-and-brain-metastases-of-colorectal-cancer-100550662","NCT06449989","Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Colorectal Cancer","GENCONCOR-1","Inclusion Criteria:\n\n1. Men and women over 18 years of age.\n2. Histologically confirmed cancer of the colon or rectum.\n3. Histologically confirmed metastatic lesion of the brain.\n4. Neurosurgical resection for brain metastases of colorectal cancer.\n5. Presence of paired tumor samples (both primary tumor and intracranial material).\n\nExclusion Criteria:\n\n1. Missing one sample from a pair of tumor samples.\n2. Low quality or lack of tumor material for molecular genetic research.",{"count":105,"type":21},30,"GENCONCOR-1 study is translational research aimed to investigate the concordance of the molecular genetic profile of the primary tumor and brain metastases (BM) of colorectal cancer (CRC). The study was conducted by post hoc analysis of pairs of samples of histological material with determination of the mutational status of genes KRAS, NRAS, BRAF, HER2 and MSI.",[108,109,30,110,111,112],"Colorectal Cancer Metastatic","Brain Metastases, Adult","BRAF Gene Mutation","HER2 Gene Mutation","MSI",[108,109,30,110,111,112],"2025-08-07",{"date":116,"type":45},"2025-08-12",{"date":118,"type":45},"2024-04-01",{"date":120,"type":21},"2027-09",{"name":122,"class":95},"Blokhin's Russian Cancer Research Center",1,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":132,"sex":17,"minAge":18,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":138,"conditions":139,"keywords":145,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":123},"100533709","phase-2-leflunomide-or-combination-of-mek-inhibitor-and-hydroxychloroquine-for-refractory-patients-with-ras-mutations-100533709","NCT06229340","Leflunomide or Combination of MEK Inhibitor and Hydroxychloroquine for Refractory Patients With RAS Mutations","New Therapeutic Approaches for Tumors With RAS Gene Mutations","NТО-RAS","Inclusion Criteria:\n\n1. Patient is able to provide informed consent and sign approved consent forms to participate in the study.\n2. Patient age is at least 18 years old.\n3. Performance status Eastern Cooperative Oncology Group (ECOG) 0-2.\n4. Histologically confirmed metastatic metastatic disease stage 4.\n5. Must have documented RAS (KRAS, HRAS, NRAS) mutation identified within the last 5 years by a local test on tumor tissue.\n6. More than 2 lines of standard drug antitumor therapy in the anamnesis.\n7. Must have disease progression as defined by RECIST version 1.1 criteria\n8. Appropriate hematologic and liver function:\n\n   * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL (1500\u002FμL)\n   * Lymphocyte count ≥ 0.5 x 109\u002FL (500\u002FμL)\n   * Platelet count ≥ 100 x 109\u002FL (100,000\u002FμL) without transfusion\n   * Hemoglobin ≥ 90 g\u002FL without transfusion.\n   * Creatinine clearance ≥ 40 mL\u002Fmin\n   * Serum albumin ≥ 25 g\u002FL (2.5 g\u002FdL)\n   * Serum bilirubin ≤ 1.5 x HGH, with the following exception:\n   * Patients with known Gilbert's disease or liver metastases: serum bilirubin level ≤ 3 x IUH\n   * AST, ALT, and alkaline phosphate ≤ 2.5 x HGN;\n\n10\\. For women of childbearing potential: consent to abstinence (abstain from heterosexual intercourse) or use at least two forms of effective contraception with an ineffectiveness rate \\\u003C 1% per year during treatment.\n\n11\\. Patients with asymptomatic new or advanced brain metastases (active brain metastases) are eligible to participate if the treating physician determines that localized treatment is not required.\n\nExclusion Criteria:\n\n1. Age over 85 years.\n2. Рresence of acute or active chronic infections.\n3. Impaired renal and hepatic function; - left ventricular ejection fraction (LVEF) \\\u003C 45%\n4. Known history of acute or chronic hepatitis B or C due to known potential hepatotoxicity of leflunomide.\n5. History of allergic reactions associated with compounds similar in chemical or biological composition to leflunomide or teriflunomide or other drugs in the combination.\n6. Uncontrolled intercurrent disease, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmias, or mental illness\u002Fsocial situations that limit study compliance.\n7. Patients should not be pregnant or breastfeeding due to the potential for teratogenic effects and side effects of planned chemotherapeutic regimens.\n8. History of retinal disease (retinal tear, exudate, hemorrhage) or retinal vein occlusion, central serous retinopathy or retinal pigment epithelium detachment, or current risk factors for ROS (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes).\n\nExit criteria:\n\n1. Refusal to continue participation in the study.\n2. Intolerable toxicity.\n3. Progression according to RECIST 1.1 and IRECIST criteria or clinically significant (in the opinion of the physician) progression requiring a change in anticancer treatment.\n4. Non-compliance with IND procedures.",true,"85 Years",{"count":135,"type":21},20,[137],"PHASE2","There is a huge variety of nucleotide substitutions that activate RAS. The search for new \"universal\" drugs for the RAS pathway that either interfere with RAS upregulation upstream in the signaling pathway or offset the consequences of RAS activation is important for improving therapeutic outcomes for patients with refractory malignancies.\n\nThe use of leflunomide or the combination of MEK inhibitor + hydroxychloroquine ± bevacizumab is promising for patients with mutations in RAS cascade genes who have failed all existing treatment standards.",[140,75,141,142,143,31,144],"RAS Mutation","Colorectal Cancer Recurrent","Pancreas Cancer","Lung Cancer","Refractory Cancer",[140,75,146,142,31,143,144],"Colorectal Cancer","2024-01-19",{"date":149,"type":45},"2024-01-29",{"date":151,"type":45},"2023-10-03",{"date":153,"type":21},"2026-10-01",{"name":155,"class":95},"N.N. Petrov National Medical Research Center of Oncology"]