[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kumquat Biosciences Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":176},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,53,78,105,133,154],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100624207","phase-2-kqb198-in-combination-with-imatinib-in-participants-with-advancedmetastatic-gist-in-1st-line-setting-100624207",false,"NCT07406633","KQB198 in Combination With Imatinib in Participants With Advanced\u002FMetastatic GIST in 1st Line Setting","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","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.","ALL","18 Years",{"count":19,"type":20},46,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","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.",[26,27,28,29,30],"GIST - Gastrointestinal Stromal Tumor","GIST","GIST Metastatic Cancer","Gastro Intestinal Stromal Tumour","Gastrointestinal Tumors",[32,33,34,35,36,37,38,39],"KQB198","imatinib","gleevec","gist","gastrointestinal stromal tumor","gastro intestinal stromal tumor","gist first line","gist 1st line","RECRUITING","2026-05-18",{"date":43,"type":44},"2026-05-19","ACTUAL",{"date":46,"type":20},"2026-05",{"date":48,"type":20},"2028-10",{"name":50,"class":51},"Kumquat Biosciences Inc.","INDUSTRY",8,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100608911","phase-1-a-study-to-investigate-the-safety-and-efficacy-of-kqb548-in-participants-with-advanced-solid-malignancies-100608911","NCT07207707","A Study to Investigate the Safety and Efficacy of KQB548 in Participants With Advanced Solid Malignancies","A Phase 1a, Open-label, Multicenter, Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB548 in Participants With Advanced Solid Malignancies With a KRAS G12D Mutation","Inclusion Criteria:\n\n* Pathologically confirmed, locally advanced or metastatic PDAC, CRC, or NSCLC with a KRAS G12D mutation\n* Progressed on, or intolerant to at least one prior line of systemic standard of care therapy\n* Measurable disease according to RECIST v1.1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Previous treatment with a KRAS G12D inhibitor or pan-RAS inhibitor\n* History of intestinal disease, uncontrolled inflammatory bowel disease (e.g., Crohn's disease, Ulcerative Colitis), major esophageal or gastric surgery, or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study intervention or result in inability to swallow oral medications\n* Poorly controlled ascites and\u002For pleural effusion\n* Requires treatment with a strong and\u002For moderate CYP3A inhibitor or inducer\n* Requires treatment with a proton-pump inhibitor",{"count":61,"type":20},78,[63],"PHASE1","The goal of this trial is to learn if KQB548 works to treat patients with advanced solid malignancies with a KRAS G12D mutation. It will also learn about the safety of KQB548. The main questions it aims to answer are:\n\n* What is the safe dose of KQB548?\n* Does KQB548 decrease the size of the tumor?\n* What happens to KQB548 in the body?",[66],"Solid Tumor Malignancies",[68,69],"KRAS","G12D",{"date":71,"type":44},"2026-05-20",{"date":73,"type":44},"2025-09-16",{"date":75,"type":20},"2027-03",{"name":50,"class":51},13,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100571494","phase-1-a-study-to-investigate-the-safety-and-efficacy-of-kqb365-as-monotherapy-and-in-combination-in-participants-with-advanced-solid-malignancies-100571494","NCT06720987","A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies","A Phase 1\u002F1b, Open-label, Multicenter, Dose Escalation and Dose Optimization Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB365 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations","Inclusion Criteria:\n\n* PART 1 (monotherapy and combo therapy with KQB198): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation.\n* PART 1 (combo therapy with Cetuximab) \\& PART 2: Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with either a KRAS G12C or KRAS G12S mutation.\n* Unresectable or metastatic disease\n* No available treatment with curative intent\n* Adequate organ function\n* Measurable disease per RECIST v1.1\n\nExclusion Criteria:\n\n* Active primary central nervous system tumors\n* Cardiac abnormalities\n* Active interstitial lung disease\n* Unable to swallow or GI condition that prevents absorption for patients in KQB198 combination cohorts",{"count":86,"type":20},140,[63],"The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365. The main questions it aims to answer are:\n\n* What is the safe dose of KQB365 by itself, in combination with cetuximab, or in combination with KQB198?\n* Does KQB365 alone, in combination with cetuximab, or in combination with KQB198 decrease the size of the tumor?\n* What happens to KQB365 in the body?\n\nParticipants will:\n\n* Receive KQB365 infusion weekly alone, in combination with cetuximab, or in combination with oral KQB198.\n* Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.",[90,91,66,92],"KRAS G12C Mutation","KRAS G12S Mutation","CRC (Colorectal Cancer)",[94,95,32],"cetuximab","KQB365","2026-04-20",{"date":98,"type":44},"2026-04-23",{"date":100,"type":44},"2025-02-04",{"date":102,"type":20},"2030-06-30",{"name":50,"class":51},11,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":115,"conditions":116,"keywords":123,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":130,"leadSponsor":132,"locationsCount":4},"100634670","phase-1-a-study-to-investigate-the-safety-and-efficacy-of-kqb368-as-monotherapy-in-participants-with-advanced-solid-malignancies-100634670","NCT07542704","A Study to Investigate the Safety and Efficacy of KQB368 as Monotherapy in Participants With Advanced Solid Malignancies","A Phase 1\u002F1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB368 in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations","* Histologically confirmed diagnosis of a solid tumor\n* Malignancy with either a KRAS G12C or KRAS G12S mutation\n* Unresectable or metastatic disease\n* No available treatment with curative intent\n* Adequate organ function\n* Measurable disease per RECIST v1.1\n* Must be able to swallow with no GI condition that prevents absorption",{"count":113,"type":20},48,[63],"The goal of this study is to learn if KQB368 works to treat advanced solid malignancies in adults. The study will also learn about the safety of KQB368. The main questions the study aims to answer are:\n\n* What is the safe dose of KQB368 as a monotherapy?\n* Does KQB368 decrease the size of the tumor?\n* What happens to KQB368 in the body?\n\nParticipants will:\n\n* Take KQB368 orally daily in 21-day cycles\n* Return to the study site about 7 times in the first 5 weeks, and then once at the beginning of every 21-day cycle after that",[117,118,119,120,121,122],"Advanced Solid Tumors","Colorectal Cancer (CRC)","Non-Small Cell Lung Cancer","Uterine Cancer","KRAS G12C Mutations","KRAS G12S Mutations",[124],"KQB368","NOT_YET_RECRUITING","2026-04-17",{"date":128,"type":44},"2026-04-21",{"date":46,"type":20},{"date":131,"type":20},"2029-12",{"name":50,"class":51},{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":21,"phases":142,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},"100592544","phase-1-a-study-to-investigate-the-safety-and-efficacy-of-kqb168-as-monotherapy-and-in-combination-in-participants-with-advanced-solid-malignancies-100592544","NCT06994806","A Study to Investigate the Safety and Efficacy of KQB168 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies","A Phase 1, Open-label, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB168 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Malignancies","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of solid tumor malignancy.\n* Unresectable or metastatic disease that has progressed on immunotherapy.\n* No available treatment with curative intent\n* Adequate organ function\n* Measurable disease per RECIST v1.1\n\nExclusion Criteria:\n\n* Active primary central nervous system tumors\n* Cardiac abnormalities\n* History of lung diseases\n* Any condition that may impair drug absorption or prevent oral dosing\n* Known history of immune-mediated colitis and uncontrolled autoimmune diseases",{"count":141,"type":20},84,[63],"The goal of this clinical trial is to learn if KQB168 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB168. The main questions it aims to answer are:\n\n* What is the safe dose of KQB168 by itself or in combination with pembrolizumab?\n* Does KQB168 alone or in combination with pembrolizumab decrease the size of the tumor?\n* What happens to KQB168 in the body?\n\nParticipants will:\n\n* Take KQB168 daily, alone or in combination with pembrolizumab\n* Visit the clinic about 8 times in the first 8 weeks, and then once every 3 weeks after that",[66],"2026-02-27",{"date":147,"type":44},"2026-03-03",{"date":149,"type":44},"2025-06-24",{"date":151,"type":20},"2028-05-31",{"name":50,"class":51},15,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":21,"phases":163,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},"100555070","phase-1-a-study-to-investigate-the-safety-and-efficacy-of-kqb198-as-monotherapy-and-in-combination-in-participants-with-advanced-solid-malignancies-100555070","NCT06507306","A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies","A Phase 1\u002F1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB198 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies","Inclusion Criteria:\n\n* PART 1 - Histologically confirmed diagnosis of a solid tumor malignancy with any of the following oncogenic mutations: EGFR, RAS, PTPN11, or SOS1 mutations, or inactivating mutations of NF1.\n* PART 1 - (Osimertinib and Amivantamab arms) and Part 2 Cohort A and Cohort B: Histologically confirmed diagnosis of NSCLC with activating EGFR mutation and progression on osimertinib\n* Part 3 - Cohort A: Histologically confirmed diagnosis of NSCLC with exon 20 insertion EGFR mutation\n* Unresectable or metastatic disease\n* No available treatment with curative intent\n* Adequate organ function\n* Measurable disease per RECIST 1.1.\n\nExclusion Criteria:\n\n* Prior therapy with a similar mechanism of action to KQB198\n* History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow\n* History of interstitial lung disease\n* Cardiac abnormalities",{"count":162,"type":20},100,[63],"The goal of this clinical trial is to learn if KQB198 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB198. The main questions it aims to answer are:\n\n* What is the safe dose of KQB198 by itself or in combination with other anti-cancer drugs?\n* Does KQB198 alone or in combination with other anti-cancer drugs decrease the size of the tumor?\n* What happens to KQB198 in the body?\n\nParticipants will:\n\n* Take KQB198 daily, alone or in combination with another anti-cancer drug\n* Visit the clinic about 8 times in the first 8 weeks, and then once every 4 weeks after that",[166],"Solid Tumor, Adult","2026-02-04",{"date":169,"type":44},"2026-02-06",{"date":171,"type":44},"2024-06-03",{"date":173,"type":20},"2027-01-31",{"name":50,"class":51},35,""]