[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07406633":3,"trial-entities:NCT07406633":253,"trial-summary:NCT07406633":259},{"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":37,"primary_purpose":38,"phases":39,"enrollment_info":41,"interventions":44,"primary_outcomes":54,"secondary_outcomes":59,"sex":89,"minimum_age":90,"maximum_age":17,"healthy_volunteers":91,"eligibility_criteria":92,"std_ages":105,"locations":108,"central_contacts":244,"overall_officials":250,"references":251,"see_also_links":252},"NCT07406633","KQB198-103","KQB198 in Combination With Imatinib in Participants With Advanced\u002FMetastatic GIST in 1st Line Setting (SynerGIST-1st Line)","A Phase 2, Multicenter, Study Evaluating the Efficacy, Safety, Tolerability, Pharmacokinetics of KQB198 in Combination With Imatinib in Participants With Advanced\u002FMetastatic GI Stromal Tumor in 1st Line Setting","RECRUITING","2028-10","2026-07","2026-08-10","2026-06-23","Kumquat Biosciences Inc.","INDUSTRY",true,"This study will test an experimental drug called KQB198 in combination with imatinib. The goal is to determine if this combination is safe and tolerable and assess how effective the combination is at treating GIST. Imatinib has been approved by the FDA for the treatment of different types of cancer including GIST.",null,[19,20,21,22,23],"GIST - Gastrointestinal Stromal Tumor","GIST","GIST Metastatic Cancer","Gastro Intestinal Stromal Tumour","Gastrointestinal Tumors",[25,26,27,28,29,30,31,32,5,33,34,35,36],"KQB198","imatinib","gleevec","gist","gastrointestinal stromal tumor","gastro intestinal stromal tumor","gist first line","gist 1st line","SynerGIST","SynerGIST-1","SynerGIST-1st","SynerGIST-1st Line","INTERVENTIONAL","TREATMENT",[40],"PHASE2",{"count":42,"type":43},46,"ESTIMATED",[45,50],{"type":46,"name":25,"description":47,"armGroupLabels":48},"DRUG","Oral KQB198",[49],"KQB198 in Combination with Imatinib",{"type":46,"name":51,"description":52,"armGroupLabels":53},"Imatinib (Gleevec)","Oral Imatinib",[49],[55],{"measure":56,"description":57,"timeFrame":58},"Objective response rate (ORR)","Evaluate efficacy of study treatment, as measured by Objective Response Rate (ORR) using Response Evaluation Criteria in Gastrointestinal Stromal Tumors (GIST). Objective response is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from 1st dose of study treatment until last dose.","30 months",[60,63,66,69,73,76,80,83,86],{"measure":61,"description":62,"timeFrame":58},"Duration of response (DOR)","Duration of response defined as the time from date of the first documentation of objective tumor response (CR or PR) based on RECIST v1.1 to the first documentation of either PD or death due to any cause, whichever occurs first.",{"measure":64,"description":65,"timeFrame":58},"Disease control rate (DCR)","Disease control rate is the proportion of subjects that experience confirmed complete response (CR), partial response (PR), or stable disease based on RECIST v1.1 during the time period from 1st dose of study treatment until last dose.",{"measure":67,"description":68,"timeFrame":58},"Time to response (TTR)","Time to response is defined as time from 1st dose of study treatment to date of 1st documentation of objective tumor response (CR or PR) based on RECIST v1.1.",{"measure":70,"description":71,"timeFrame":72},"Progression-free survival (PFS)","Progression-free survival is defined as the time from enrollment to the date of Progressive Disease (PD) based on RECIST v1.1 or death due to any cause, whichever occurs first. PFS at 6 months will also be characterized which indicates the proportion of subjects that experience progression within 6 months from time of enrollment.","Up to 30 months",{"measure":74,"description":75,"timeFrame":72},"Overall survival (OS)","Evaluate efficacy of study treatment characterized by OS. Overall survival is defined as the time from start of treatment to death.",{"measure":77,"description":78,"timeFrame":79},"Number of patients who experience treatment-emergent adverse advents, serious adverse events, and dose-limiting toxicities (Part 1)","Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs), from first dose of study treatment to 28 days after last dose of study treatment.","From enrollment to the end of treatment",{"measure":81,"description":82,"timeFrame":72},"Area under the curve (AUC)","Area under the concentration-time curve (AUC) of KQB198 in combination with imatinib.",{"measure":84,"description":85,"timeFrame":72},"Maximum plasma concentration (Cmax)","Maximum plasma concentration (Cmax) of KQB198 in combination with imatinib.",{"measure":87,"description":88,"timeFrame":72},"Time to maximum plasma concentration (Tmax)","Time to maximum plasma concentration (Tmax) of KQB198 in combination with imatinib.","ALL","18 Years",false,{"inclusion":93,"exclusion":100,"raw_text":104},[94,95,96,97,98,99],"Unresectable or metastatic disease","Tissue confirmation of GIST","Valid results from local testing of blood or tumor tissue documenting the presence of a KIT mutation (must not have exon 9 mutation) or PDGFRA mutation (must not have PDGFRA D842V).","Measurable disease per RECIST v1.1.","Patients must be in 1st line of treatment for advanced or metastatic disease. Prior imatinib is allowed in adjuvant or neoadjuvant setting, as long as imatinib was stopped over 1 year ago.","Adequate organ function and performance status",[101,102,103],"Unable to swallow or GI condition that prevents absorption.","Other active malignancies within the last 2 years.","History of hypersensitivity to any component of KQB198 or imatinib.","Inclusion Criteria\n\nAll Participants:\n\n* Unresectable or metastatic disease\n* Tissue confirmation of GIST\n* Valid results from local testing of blood or tumor tissue documenting the presence of a KIT mutation (must not have exon 9 mutation) or PDGFRA mutation (must not have PDGFRA D842V).\n* Measurable disease per RECIST v1.1.\n* Patients must be in 1st line of treatment for advanced or metastatic disease. Prior imatinib is allowed in adjuvant or neoadjuvant setting, as long as imatinib was stopped over 1 year ago.\n* Adequate organ function and performance status\n\nExclusion Criteria\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Unable to swallow or GI condition that prevents absorption.\n* Other active malignancies within the last 2 years.\n* History of hypersensitivity to any component of KQB198 or imatinib.",[106,107],"ADULT","OLDER_ADULT",[109,118,126,133,140,148,156,164,172,180,188,196,204,212,220,228,236],{"facility":110,"status":8,"city":111,"state":112,"zip":113,"country":114,"geoPoint":115},"USC Norris Comprehensive Cancer Center","Los Angeles","California","90033","United States",{"lat":116,"lon":117},34.05223,-118.24368,{"facility":119,"status":8,"city":120,"state":121,"zip":122,"country":114,"geoPoint":123},"Mayo Clinic - Jacksonville","Jacksonville","Florida","32224",{"lat":124,"lon":125},30.33218,-81.65565,{"facility":127,"status":8,"city":128,"state":121,"zip":129,"country":114,"geoPoint":130},"Sylvester Comprehensive Cancer Center","Miami","33136",{"lat":131,"lon":132},25.77427,-80.19366,{"facility":134,"status":8,"city":135,"state":121,"zip":136,"country":114,"geoPoint":137},"Moffitt Cancer Center","Tampa","33612",{"lat":138,"lon":139},27.94752,-82.45843,{"facility":141,"status":8,"city":142,"state":143,"zip":144,"country":114,"geoPoint":145},"University of Chicago Medical Center","Chicago","Illinois","60637",{"lat":146,"lon":147},41.85003,-87.65005,{"facility":149,"status":8,"city":150,"state":151,"zip":152,"country":114,"geoPoint":153},"University of Iowa Health Care","Iowa City","Iowa","52242",{"lat":154,"lon":155},41.66113,-91.53017,{"facility":157,"status":8,"city":158,"state":159,"zip":160,"country":114,"geoPoint":161},"Dana-Farber Cancer Institute","Boston","Massachusetts","02215",{"lat":162,"lon":163},42.35843,-71.05977,{"facility":165,"status":8,"city":166,"state":167,"zip":168,"country":114,"geoPoint":169},"University of Michigan Hospitals","Ann Arbor","Michigan","48109",{"lat":170,"lon":171},42.27756,-83.74088,{"facility":173,"status":8,"city":174,"state":175,"zip":176,"country":114,"geoPoint":177},"Mayo Clinic - Rochester","Rochester","Minnesota","55905",{"lat":178,"lon":179},44.02163,-92.4699,{"facility":181,"status":8,"city":182,"state":183,"zip":184,"country":114,"geoPoint":185},"Northwell Health\u002FR.J. Zuckerberg Cancer Center","Lake Success","New York","11042",{"lat":186,"lon":187},40.77066,-73.71763,{"facility":189,"status":8,"city":190,"state":191,"zip":192,"country":114,"geoPoint":193},"University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27599",{"lat":194,"lon":195},35.9132,-79.05584,{"facility":197,"status":8,"city":198,"state":199,"zip":200,"country":114,"geoPoint":201},"Cleveland Clinic","Cleveland","Ohio","44195",{"lat":202,"lon":203},41.4995,-81.69541,{"facility":205,"status":8,"city":206,"state":207,"zip":208,"country":114,"geoPoint":209},"Oregon Health & Science University","Portland","Oregon","97239",{"lat":210,"lon":211},45.52345,-122.67621,{"facility":213,"status":8,"city":214,"state":215,"zip":216,"country":114,"geoPoint":217},"Fox Chase Cancer Center","Philadelphia","Pennsylvania","19111",{"lat":218,"lon":219},39.95238,-75.16362,{"facility":221,"status":8,"city":222,"state":223,"zip":224,"country":114,"geoPoint":225},"UT MD Anderson Cancer Center","Houston","Texas","77030",{"lat":226,"lon":227},29.76328,-95.36327,{"facility":229,"status":8,"city":230,"state":231,"zip":232,"country":114,"geoPoint":233},"Huntsman Cancer Institute","Salt Lake City","Utah","84112",{"lat":234,"lon":235},40.76078,-111.89105,{"facility":237,"status":8,"city":238,"state":239,"zip":240,"country":114,"geoPoint":241},"Fred Hutchinson Cancer Center","Seattle","Washington","98109",{"lat":242,"lon":243},47.60621,-122.33207,[245],{"name":246,"role":247,"phone":248,"email":249},"Kumquat Clinical Development","CONTACT","858-214-2700","kumquatstudies@kumquatbio.com",[],[],[],{"nct_id":4,"conditions":254,"biomarkers":256},[255],"Gastrointestinal Stromal Tumor",[257,258],"KIT Gene","PDGFRA Gene",{"nct_id":4,"found":15,"summary":260,"prompt_version":270},{"design":261,"status":262,"heading":263,"summary":264,"follow_up":265,"word_count":266,"commitments":267,"compensation":268,"drugs_mentioned":269},"This is an interventional study with a planned enrollment of 46 participants. The phase of the study is not specified.","completed","KQB198 with Imatinib for Advanced GIST","This study is testing an experimental drug called KQB198 in combination with imatinib (Gleevec) for people with advanced or metastatic (spread to other parts of the body) Gastrointestinal Stromal Tumor (GIST). The main goal is to see how many participants respond to the treatment, measured over 30 months. To join, you must have GIST that cannot be removed by surgery or has spread, and your tumor tissue must show specific KIT or PDGFRA gene mutations (but not certain types). The study aims to find out if this drug combination is safe, tolerable, and effective. The status of this study is currently unclear.","The primary endpoint, objective response rate, will be measured at 30 months.",102,"Not specified in the trial record.","Not stated in the trial record.",[25,51],"v2"]