[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"solid-tumors-with-hras-alterations\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:solid-tumors-with-hras-alterations":59},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100518120",false,"NCT06026410","KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors","Phase 1, First-in-Human, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of KO-2806 When Administered as Monotherapy and in Combination Therapy in Adult Patients With Advanced Solid Tumors","FIT-001","Inclusion Criteria:\n\n* At least 18 years of age.\n* Histologically or cytologically confirmed advanced solid tumors\n\n  * Arm #1 (KO-2806 monotherapy): Patients who have progressed on, or are refractory to, standard of care (SOC) treatments with advanced solid tumors, specifically: HRAS-mutant and\u002For amplified tumors (any solid tumor type); HRAS overexpression (only for HNSCC tumors); KRAS and\u002For NRAS, and\u002For HRAS-mutant and\u002For amplified NSCLC or CRC; KRAS-mutant and\u002For amplified PDAC\n  * Arm #2 (Combination): Patients who have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic RCC with predominantly clear cell subtype; non-clear cell RCC patients who are either treatment-naïve or have received any prior systemic treatment for locally advanced and metastatic RCC.\n  * Arm #3 (Combination): Patients who have received at least 1 prior systemic therapy including available approved SOC treatments for KRAS G12C-mutant locally advanced or metastatic NSCLC, CRC, or PDAC.\n  * Arm #4 (Combination): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies.\n  * Arm #5 (Cabozantinib monotherapy): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies.\n  * Arm #6 (Cabozantinib rollover to combination): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies.\n  * Arm #7 (Combination): Patients who have received at least 1 prior systemic therapy including available approved SOC treatments for KRAS G12C-mutant locally advanced or metastatic NSCLC\n* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* Karnofsky Performance Status of 70 or higher with no clinically significant deterioration over the previous 2 weeks.\n* Acceptable liver, renal, endocrine, and hematologic function.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Any use of anticancer therapy within 14 days or 5 half-lives (whichever is shorter) of Cycle 1 Day 1.\n* Prior treatment with an FTI or HRAS inhibitor.\n* Major surgery, other than local procedures, within 28 days prior to Cycle 1 Day 1, without complete recovery.\n* Spinal cord compression, leptomeningeal disease, or clinically active CNS metastases.\n* Toxicity (excluding alopecia) from prior therapy that has not been completely resolved to baseline at the time of consent.\n* Active or prior documented autoimmune or inflammatory disorders within the past 5 years prior to Cycle 1 Day 1 (with exceptions).\n* Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.\n* Inability to swallow, impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the trial drugs.\n* Inadequate cardiac and\u002For vascular function, including receipt of treatment for unstable angina, myocardial infarction, and\u002For cerebrovascular attack within the prior 6 months, mean QTcF ≥470 ms, or Class II or greater congestive heart failure.\n* Other invasive malignancy within 2 years.\n* Other protocol-defined exclusion criteria may apply.","ALL","18 Years",{"count":19,"type":20},300,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This first-in-human (FIH) dose-escalation and dose-validation\u002Fexpansion study will assess KO-2806, a farnesyltransferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.",[26,27,28,29,30,31,32],"Solid Tumors With HRAS Alterations","Non Small Cell Lung Cancer (NSCLC)","Colorectal Cancer (CRC)","Pancreatic Ductal Adenocarcinoma (PDAC)","Clear Cell Renal Cell Carcinoma (ccRCC)","Renal Cell Carcinoma (Kidney Cancer)","Non Clear Cell Renal Cell Carcinoma (nccRCC)",[34,35,36,37,38,39,40,41,42,43,44,45],"HRAS","KRAS","NRAS","Farnesyltransferase inhibitor (FTI)","Tyrosine Kinase inhibitor (TKI)","Phase 1","KRAS G12C inhibitor","NSCLC","ccRCC","RCC","PDAC","CRC","RECRUITING","2026-06-04",{"date":49,"type":50},"2026-06-08","ACTUAL",{"date":52,"type":50},"2023-10-18",{"date":54,"type":20},"2027-04",{"name":56,"class":57},"Kura Oncology, Inc.","INDUSTRY",38,""]