[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06655246":3,"trial-entities:NCT06655246":368,"trial-summary:NCT06655246":372},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":24,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":48,"secondary_outcomes":61,"sex":98,"minimum_age":99,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":100,"std_ages":123,"locations":126,"central_contacts":359,"overall_officials":365,"references":366,"see_also_links":367},"NCT06655246","KO-MEN-015","A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)","A Phase 1a\u002F1b Study of the Safety, Pharmacokinetics, and Antitumor Activity of the Oral Menin Inhibitor Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) After Imatinib Failure","RECRUITING","2028-12","2026-02","2026-02-05","2025-03-27","Kura Oncology, Inc.","INDUSTRY",false,"In this clinical trial, the safety, tolerability, and preliminary antitumor activity of ziftomenib in combination with imatinib will be evaluated in adults with gastrointestinal stromal tumors (GIST) who have been treated previously with imatinib.",null,[19,20,21,22,23],"Gastrointestinal Stromal Tumor (GIST)","Gastrointestinal Stromal Cancer","Gastrointestinal Stromal Neoplasm","Gastrointestinal Stromal Tumor, Malignant","Gastrointestinal Stromal Cell Tumors",[25,20,21],"Gastrointestinal Stromal Tumor","INTERVENTIONAL","TREATMENT",[29],"PHASE1",{"count":31,"type":32},157,"ESTIMATED",[34,42],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DRUG","ziftomenib","menin inhibitor",[39,40,41],"Dose Escalation","Dose Expansion","Recommended Phase 2 Dose Determination",{"type":35,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"imatinib mesylate","kinase inhibitor",[39,40,41],[47],"Gleevec",[49,53,57],{"measure":50,"description":51,"timeFrame":52},"Dose Escalation: Dose Limiting Toxicity (DLT)","Rate of DLTs per dose level","Cycle 1 (first 28 day cycle)",{"measure":54,"description":55,"timeFrame":56},"Descriptive statistics of Adverse Events (AEs)","Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0","First dose of ziftomenib up to and including 28 days after last dose of ziftomenib, or if the participant is lost to follow-up, whichever comes first",{"measure":58,"description":59,"timeFrame":60},"Dose Expansion: Clinical benefit rate (CBR)","CBR is the rate of participants achieving complete response (CR), partial response (PR), or stable disease (SD), assessed per Response Criteria in Solid Tumors (RECIST) v1.1 modified for GIST","Up to 2 years following start of treatment with ziftomenib",[62,65,68,71,74,77,81,84,87,90,92,94,96],{"measure":63,"description":64,"timeFrame":60},"Recommended Phase 2 Dose Determination and Dose Expansion: CBR","CBR is CR + PR + SD assessed per RECIST v1.1 modified for GIST",{"measure":66,"description":67,"timeFrame":60},"Overall Response Rate (ORR)","ORR is CR + PR assessed per RECIST v1.1 modified for GIST",{"measure":69,"description":70,"timeFrame":60},"Progression Free Survival (PFS)","Assessed per RECIST v1.1 modified for GIST",{"measure":72,"description":73,"timeFrame":60},"Duration of Response (DoR)","Defined as the time from the first response (CR or PR assessed per RECIST v1.1 modified for GIST) to disease progression or death from any cause",{"measure":75,"description":76,"timeFrame":60},"Overall Survival (OS)","Defined as the time from first dose of ziftomenib or imatinib (whichever is dosed first) until death from any cause",{"measure":78,"description":79,"timeFrame":80},"Maximum plasma concentration (Cmax)","Cmax of ziftomenib","Day 1 of each cycle; each cycle is 28 days",{"measure":82,"description":83,"timeFrame":80},"Time to maximum plasma concentration (Tmax)","Tmax of ziftomenib",{"measure":85,"description":86,"timeFrame":80},"Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC 0-last)","AUC 0-last of ziftomenib",{"measure":88,"description":89,"timeFrame":80},"Area under the concentration-time curve over a dosing interval (AUC tau)","AUC tau of ziftomenib",{"measure":78,"description":91,"timeFrame":80},"Cmax of imatinib",{"measure":82,"description":93,"timeFrame":80},"Tmax of imatinib",{"measure":85,"description":95,"timeFrame":80},"AUC 0-last of imatinib",{"measure":88,"description":97,"timeFrame":80},"AUC tau of imatinib","ALL","18 Years",{"inclusion":101,"exclusion":110,"raw_text":122},[102,103,104,105,106,107,108,109],"Documented diagnosis of advanced\u002Fmetastatic KIT-mutant GIST.","Documented disease progression on imatinib as current or prior therapy.","Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 at screening.","At least 1 measurable lesion per RECIST v1.1 modified for GIST.","Negative pregnancy test for participants of childbearing potential.","Adequate organ function per protocol requirements.","Resolution of all clinically significant toxicities from prior therapy to \\\u003CGrade 1 (or participant baseline) within 1 week before the first dose of study intervention.","Participant, or legally authorized representative, must be able to understand and provide written informed consent before the first screening procedure.",[111,112,113,114,115,116,117,118,119,120,121],"Diagnosis of GIST without a KIT mutation or with a T670X KIT mutation.","History of prior or current cancer that has potential to interfere with obtaining study results.","Received a prohibited medication, including investigational therapy, less than 14 days or within 5 drug half-lives before the first dose of study intervention.","Active central nervous system metastases.","Uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.","Mean corrected QT interval (QTcF) greater than 470ms.","Left ventricular ejection fraction (LVEF) \\\u003C50%.","Major surgery within 2 weeks before the first dose of study intervention.","Is pregnant or breastfeeding.","Gastrointestinal abnormalities that may impact taking study intervention by mouth.","Actively bleeding, excluding hemorrhoidal or gum bleeding.","Key Inclusion Criteria:\n\n* Documented diagnosis of advanced\u002Fmetastatic KIT-mutant GIST.\n* Documented disease progression on imatinib as current or prior therapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 at screening.\n* At least 1 measurable lesion per RECIST v1.1 modified for GIST.\n* Negative pregnancy test for participants of childbearing potential.\n* Adequate organ function per protocol requirements.\n* Resolution of all clinically significant toxicities from prior therapy to \\\u003CGrade 1 (or participant baseline) within 1 week before the first dose of study intervention.\n* Participant, or legally authorized representative, must be able to understand and provide written informed consent before the first screening procedure.\n\nKey Exclusion Criteria:\n\n* Diagnosis of GIST without a KIT mutation or with a T670X KIT mutation.\n* History of prior or current cancer that has potential to interfere with obtaining study results.\n* Received a prohibited medication, including investigational therapy, less than 14 days or within 5 drug half-lives before the first dose of study intervention.\n* Active central nervous system metastases.\n* Uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.\n* Mean corrected QT interval (QTcF) greater than 470ms.\n* Left ventricular ejection fraction (LVEF) \\\u003C50%.\n* Major surgery within 2 weeks before the first dose of study intervention.\n* Is pregnant or breastfeeding.\n* Gastrointestinal abnormalities that may impact taking study intervention by mouth.\n* Actively bleeding, excluding hemorrhoidal or gum bleeding.",[124,125],"ADULT","OLDER_ADULT",[127,136,144,152,159,166,173,180,188,195,203,210,217,225,233,241,249,253,261,268,275,283,291,299,307,311,318,322,329,336,343,351],{"facility":128,"status":8,"city":129,"state":130,"zip":131,"country":132,"geoPoint":133},"University of Alabama at Birmingham","Birmingham","Alabama","35233","United States",{"lat":134,"lon":135},33.52066,-86.80249,{"facility":137,"status":8,"city":138,"state":139,"zip":140,"country":132,"geoPoint":141},"Mayo Clinic Cancer Center","Phoenix","Arizona","85054",{"lat":142,"lon":143},33.44838,-112.07404,{"facility":145,"status":8,"city":146,"state":147,"zip":148,"country":132,"geoPoint":149},"University of California, San Diego","La Jolla","California","92093",{"lat":150,"lon":151},32.84727,-117.2742,{"facility":153,"status":8,"city":154,"state":147,"zip":155,"country":132,"geoPoint":156},"University of Southern California","Los Angeles","90033",{"lat":157,"lon":158},34.05223,-118.24368,{"facility":160,"status":8,"city":161,"state":147,"zip":162,"country":132,"geoPoint":163},"University Of California, Irvine","Orange","92868",{"lat":164,"lon":165},33.78779,-117.85311,{"facility":167,"status":8,"city":168,"state":147,"zip":169,"country":132,"geoPoint":170},"Stanford Cancer Institute","Palo Alto","94304",{"lat":171,"lon":172},37.44188,-122.14302,{"facility":174,"status":8,"city":175,"state":147,"zip":176,"country":132,"geoPoint":177},"UCLA Santa Monica Medical Center","Santa Monica","90404",{"lat":178,"lon":179},34.01949,-118.49138,{"facility":181,"status":8,"city":182,"state":183,"zip":184,"country":132,"geoPoint":185},"University of Colorado Cancer Center","Aurora","Colorado","80045",{"lat":186,"lon":187},39.72943,-104.83192,{"facility":189,"status":8,"city":190,"state":183,"zip":191,"country":132,"geoPoint":192},"Sarah Cannon Research Institute","Denver","80220",{"lat":193,"lon":194},39.73915,-104.9847,{"facility":196,"status":8,"city":197,"state":198,"zip":199,"country":132,"geoPoint":200},"Yale University School of Medicine","New Haven","Connecticut","06511",{"lat":201,"lon":202},41.30815,-72.92816,{"facility":137,"status":8,"city":204,"state":205,"zip":206,"country":132,"geoPoint":207},"Jacksonville","Florida","32224",{"lat":208,"lon":209},30.33218,-81.65565,{"facility":211,"status":8,"city":212,"state":205,"zip":213,"country":132,"geoPoint":214},"University of Miami","Miami","33136",{"lat":215,"lon":216},25.77427,-80.19366,{"facility":218,"status":8,"city":219,"state":220,"zip":221,"country":132,"geoPoint":222},"Northwestern University","Chicago","Illinois","60611",{"lat":223,"lon":224},41.85003,-87.65005,{"facility":226,"status":8,"city":227,"state":228,"zip":229,"country":132,"geoPoint":230},"University of Iowa","Iowa City","Iowa","52242",{"lat":231,"lon":232},41.66113,-91.53017,{"facility":234,"status":8,"city":235,"state":236,"zip":237,"country":132,"geoPoint":238},"Johns Hopkins University","Baltimore","Maryland","21287",{"lat":239,"lon":240},39.29038,-76.61219,{"facility":242,"status":8,"city":243,"state":244,"zip":245,"country":132,"geoPoint":246},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"lat":247,"lon":248},42.35843,-71.05977,{"facility":250,"status":8,"city":243,"state":244,"zip":251,"country":132,"geoPoint":252},"Harvard University","02215",{"lat":247,"lon":248},{"facility":254,"status":8,"city":255,"state":256,"zip":257,"country":132,"geoPoint":258},"University of Michigan","Ann Arbor","Michigan","48109",{"lat":259,"lon":260},42.27756,-83.74088,{"facility":137,"status":8,"city":262,"state":263,"zip":264,"country":132,"geoPoint":265},"Rochester","Minnesota","55905",{"lat":266,"lon":267},44.02163,-92.4699,{"facility":269,"status":8,"city":270,"state":270,"zip":271,"country":132,"geoPoint":272},"Memorial Sloan-Kettering Cancer Center","New York","10065",{"lat":273,"lon":274},40.71427,-74.00597,{"facility":276,"status":8,"city":277,"state":278,"zip":279,"country":132,"geoPoint":280},"Duke University Medical Center","Durham","North Carolina","27710",{"lat":281,"lon":282},35.99403,-78.89862,{"facility":284,"status":8,"city":285,"state":286,"zip":287,"country":132,"geoPoint":288},"Ohio State University","Columbus","Ohio","43210",{"lat":289,"lon":290},39.96118,-82.99879,{"facility":292,"status":8,"city":293,"state":294,"zip":295,"country":132,"geoPoint":296},"Oregon Health & Science University","Portland","Oregon","97239",{"lat":297,"lon":298},45.52345,-122.67621,{"facility":300,"status":8,"city":301,"state":302,"zip":303,"country":132,"geoPoint":304},"Thomas Jefferson University","Philadelphia","Pennsylvania","19107",{"lat":305,"lon":306},39.95238,-75.16362,{"facility":308,"status":8,"city":301,"state":302,"zip":309,"country":132,"geoPoint":310},"Temple University Health System","19111",{"lat":305,"lon":306},{"facility":189,"status":8,"city":312,"state":313,"zip":314,"country":132,"geoPoint":315},"Nashville","Tennessee","37203",{"lat":316,"lon":317},36.16589,-86.78444,{"facility":319,"status":8,"city":312,"state":313,"zip":320,"country":132,"geoPoint":321},"Vanderbilt University Medical Center","37232",{"lat":316,"lon":317},{"facility":189,"status":8,"city":323,"state":324,"zip":325,"country":132,"geoPoint":326},"Dallas","Texas","75230",{"lat":327,"lon":328},32.78306,-96.80667,{"facility":330,"status":8,"city":331,"state":324,"zip":332,"country":132,"geoPoint":333},"University of Texas","Houston","77030",{"lat":334,"lon":335},29.76328,-95.36327,{"facility":337,"status":8,"city":338,"state":324,"zip":339,"country":132,"geoPoint":340},"University of Texas Health Science Center","San Antonio","78229",{"lat":341,"lon":342},29.42412,-98.49363,{"facility":344,"status":8,"city":345,"state":346,"zip":347,"country":132,"geoPoint":348},"University of Utah","Salt Lake City","Utah","84112",{"lat":349,"lon":350},40.76078,-111.89105,{"facility":352,"status":8,"city":353,"state":354,"zip":355,"country":132,"geoPoint":356},"Medical College of Wisconsin","Milwaukee","Wisconsin","53226",{"lat":357,"lon":358},43.0389,-87.90647,[360],{"name":361,"role":362,"phone":363,"email":364},"Kura Medical Information 844-KURAONC","CONTACT","844-587-2662","medinfo@kuraoncology.com",[],[],[],{"nct_id":4,"conditions":369,"biomarkers":370},[25],[371],"KIT Gene",{"nct_id":4,"found":373,"summary":374,"prompt_version":384},true,{"design":375,"status":376,"heading":377,"summary":378,"follow_up":379,"word_count":380,"commitments":381,"compensation":382,"drugs_mentioned":383},"This interventional study plans to enroll 157 participants. It is evaluating the safety and effectiveness of ziftomenib in combination with imatinib.","completed","Study of Ziftomenib and Imatinib for Advanced GIST","This study is looking at a combination of two drugs, ziftomenib and imatinib mesylate, for adults with advanced gastrointestinal stromal tumors (GIST). GIST is a type of cancer that starts in the digestive tract. You might be able to join if your GIST has a specific change in the KIT gene and has gotten worse after treatment with imatinib. The study aims to see how safe the combination is, how well people tolerate it, and if it helps shrink tumors. We are also looking at how many people benefit from the treatment. The current status of this study is unclear.","The study will measure clinical benefit for up to 2 years after starting treatment with ziftomenib.",100,"Not specified in the trial record.","Not stated in the trial record.",[36,43],"v2"]