[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06507306":3,"trial-entities:NCT06507306":284,"trial-summary:NCT06507306":294},{"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":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":49,"secondary_outcomes":61,"sex":78,"minimum_age":79,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":80,"std_ages":95,"locations":98,"central_contacts":280,"overall_officials":281,"references":282,"see_also_links":283},"NCT06507306","KQB198-101","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","ACTIVE_NOT_RECRUITING","2027-01-31","2026-07","2026-07-28","2024-06-03","Kumquat Biosciences Inc.","INDUSTRY",false,"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",null,[19],"Solid Tumor, Adult",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE1",{"count":26,"type":27},92,"ACTUAL",[29,39,45],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","KQB198","Oral KQB198",[34,35,36,37,38],"Combo Therapy Dose Escalation","Combo Therapy Dose Expansion - RP2D","Combo Therapy Dose Expansion - RP2D-1","Combo Therapy Dose Expansion OBD","Monotherapy Dose Escalation",{"type":30,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Osimertinib","Oral Osimertinib",[34,35,36,37],[44],"Tagrisso",{"type":30,"name":46,"description":47,"armGroupLabels":48},"Amivantamab","Subcutaneous administration",[34,35,36,37],[50,54,58],{"measure":51,"description":52,"timeFrame":53},"Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1)","Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, SAEs, and DLTs, from first dose of study treatment to 28 days after last dose of study treatment.","28 Days",{"measure":55,"description":56,"timeFrame":57},"Recommended Phase 2 Dose (RP2D) (Part 1)","Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D.","up to 30 months",{"measure":59,"description":60,"timeFrame":57},"Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Parts 2 and 3)","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.",[62,64,66,68,70,72,74,76],{"measure":63,"timeFrame":57},"Concentration-time curve (AUC)",{"measure":65,"timeFrame":57},"Maximum plasma concentration (Cmax)",{"measure":67,"timeFrame":57},"Time to maximum plasma concentration (tmax)",{"measure":69,"timeFrame":57},"Overall survival (OS)",{"measure":71,"timeFrame":57},"Progression-free survival (PFS)",{"measure":73,"timeFrame":57},"Overall response rate (ORR)",{"measure":75,"timeFrame":57},"Duration of response (DOR)",{"measure":77,"timeFrame":57},"Time to response (TTR)","ALL","18 Years",{"inclusion":81,"exclusion":89,"raw_text":94},[82,83,84,85,86,87,88],"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.","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","Part 3 - Cohort A: Histologically confirmed diagnosis of NSCLC with exon 20 insertion EGFR mutation","Unresectable or metastatic disease","No available treatment with curative intent","Adequate organ function","Measurable disease per RECIST 1.1.",[90,91,92,93],"Prior therapy with a similar mechanism of action to KQB198","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","History of interstitial lung disease","Cardiac abnormalities","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",[96,97],"ADULT","OLDER_ADULT",[99,108,116,123,131,139,147,155,163,171,180,188,196,204,212,221,228,237,241,245,248,255,259,263,266,273],{"facility":100,"city":101,"state":102,"zip":103,"country":104,"geoPoint":105},"Sarah Cannon Research Institute at HealthONE","Denver","Colorado","80218","United States",{"lat":106,"lon":107},39.73915,-104.9847,{"facility":109,"city":110,"state":111,"zip":112,"country":104,"geoPoint":113},"Sarah Cannon Research Institute at Florida Cancer Specialists - Lake Nona -","Orlando","Florida","32827",{"lat":114,"lon":115},28.53834,-81.37924,{"facility":117,"city":118,"state":111,"zip":119,"country":104,"geoPoint":120},"Florida Cancer Specialists - Sarasota","Sarasota","34232",{"lat":121,"lon":122},27.33643,-82.53065,{"facility":124,"city":125,"state":126,"zip":127,"country":104,"geoPoint":128},"Henry Ford Health System","Detroit","Michigan","48202",{"lat":129,"lon":130},42.33143,-83.04575,{"facility":132,"city":133,"state":134,"zip":135,"country":104,"geoPoint":136},"David H. Koch Center for Cancer Center at Memorial Sloan Kettering Cancer Center","Long Island City","New York","11101",{"lat":137,"lon":138},40.74482,-73.94875,{"facility":140,"city":141,"state":142,"zip":143,"country":104,"geoPoint":144},"The Lindner Center for Research and Education at The Christ Hospital","Cincinnati","Ohio","45219",{"lat":145,"lon":146},39.12711,-84.51439,{"facility":148,"city":149,"state":150,"zip":151,"country":104,"geoPoint":152},"Sarah Cannon and HCA Research Institute","Nashville","Tennessee","37203",{"lat":153,"lon":154},36.16589,-86.78444,{"facility":156,"city":157,"state":158,"zip":159,"country":104,"geoPoint":160},"New Experimental Therapeutics of San Antonio - NEXT Oncology","San Antonio","Texas","78229",{"lat":161,"lon":162},29.42412,-98.49363,{"facility":164,"city":165,"state":166,"zip":167,"country":104,"geoPoint":168},"New Experimental Therapeutics of Virginia - NEXT Oncology","Fairfax","Virginia","22031",{"lat":169,"lon":170},38.84622,-77.30637,{"facility":172,"city":173,"state":174,"zip":175,"country":176,"geoPoint":177},"Institut Paoli-Calmettes","Marseille","Bouches-du-Rhône","13009","France",{"lat":178,"lon":179},43.29695,5.38107,{"facility":181,"city":182,"state":183,"zip":184,"country":176,"geoPoint":185},"Institut de Cancerologie de l'Ouest - site St-Herblain","Saint-Herblain","Loire-Atlantique","44800",{"lat":186,"lon":187},47.21154,-1.651,{"facility":189,"city":190,"state":191,"zip":192,"country":176,"geoPoint":193},"CHU Bordeaux - Hopital Saint-Andre","Bordeaux","Nouvelle-Aquitane","33000",{"lat":194,"lon":195},44.84124,-0.58046,{"facility":197,"city":198,"state":199,"zip":200,"country":176,"geoPoint":201},"IUCT-Oncopole","Toulouse","Occitaine","31059",{"lat":202,"lon":203},43.60426,1.44367,{"facility":205,"city":206,"state":207,"zip":208,"country":176,"geoPoint":209},"CHU de Nantes - Hopital Nord Laennec","Nantes","Pays de la Loire Region","44000",{"lat":210,"lon":211},47.21725,-1.55336,{"facility":213,"city":214,"state":215,"zip":216,"country":217,"geoPoint":218},"Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore","Rome","Lazio","00168","Italy",{"lat":219,"lon":220},41.89193,12.51133,{"facility":222,"city":223,"zip":224,"country":217,"geoPoint":225},"Istituto Nazionale Tumori IRCCS \"Fondazione G. Pascale\"","Naples","80131",{"lat":226,"lon":227},40.85216,14.26811,{"facility":229,"city":230,"state":231,"zip":232,"country":233,"geoPoint":234},"Hospital Universitari Quiron Dexeus Barcelona","Barcelona","Catalonia","08028","Spain",{"lat":235,"lon":236},41.38879,2.15899,{"facility":238,"city":230,"state":231,"zip":239,"country":233,"geoPoint":240},"Hospital Universitario Vall d'Hebron","08035",{"lat":235,"lon":236},{"facility":242,"city":230,"zip":243,"country":233,"geoPoint":244},"New Experimental Therapeutics (NEXT) Oncology Barcelona","08023",{"lat":235,"lon":236},{"facility":246,"city":230,"zip":243,"country":233,"geoPoint":247},"South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos",{"lat":235,"lon":236},{"facility":249,"city":250,"zip":251,"country":233,"geoPoint":252},"Hospital Universitario Ramon y Cajal","Madrid","28034",{"lat":253,"lon":254},40.4165,-3.70256,{"facility":256,"city":250,"zip":257,"country":233,"geoPoint":258},"South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC","28040",{"lat":253,"lon":254},{"facility":260,"city":250,"zip":261,"country":233,"geoPoint":262},"New Experimental Therapeutics (NEXT) Oncology Madrid - Hospital Quironsalud Madrid","28223",{"lat":253,"lon":254},{"facility":264,"city":250,"country":233,"geoPoint":265},"South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz",{"lat":253,"lon":254},{"facility":267,"city":268,"zip":269,"country":233,"geoPoint":270},"Hospital Quirónsalud Málaga","Málaga","29004",{"lat":271,"lon":272},36.72016,-4.42034,{"facility":274,"city":275,"zip":276,"country":233,"geoPoint":277},"Clinica Universidad de Navarra - Pamplona","Pamplona","31008",{"lat":278,"lon":279},42.81687,-1.64323,[],[],[],[],{"nct_id":4,"conditions":285,"biomarkers":288},[286,287],"Lung Non-Small Cell Carcinoma","Solid Neoplasm",[289,290,291,292,293],"NF1 Gene","PTPN11 Gene","RAS Family Oncogene","Soluble Epidermal Growth Factor Receptor","SOS1 Gene",{"nct_id":4,"found":295,"summary":296,"prompt_version":17},true,{"design":297,"status":298,"heading":6,"summary":299,"follow_up":297,"word_count":300,"commitments":301,"compensation":302,"drugs_mentioned":303},"Not specified.","completed","{\n   \"KQB198 for Advanced Solid Tumors\",\n   \"This study is testing a new drug called KQB198 for adults with advanced solid tumors. Researchers want to find out if KQB198 is safe and if it can shrink tumors, either when given alone or with other anti-cancer drugs like Osimertinib or Amivantamab. To join, you must have a solid tumor with specific genetic changes (mutations) in genes like EGFR, RAS, PTPN11, SOS1, or NF1. The study will measure side effects, find the best dose of KQB198, and see how many participants' tumors shrink. The study plans to enroll 92 participants.\",\n  \"design\": \"This is an interventional study with an unclear phase, planning to enroll 92 participants. It will test KQB198 alone or in combination with other drugs.\",\n  \"commitments\": \"You would take KQB198 daily, alone or with another anti-cancer drug. You would visit the clinic about 8 times in the first 8 weeks, then once every 4 weeks after that.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"The study will measure outcomes for up to 30 months, including efficacy and optimal biologic dose.\",\n}",180,"Not specified in the trial record.","Not stated in the trial record.",[31,40,46]]