Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2026-02-24 @ 7:46 AM
Study NCT ID:
NCT06507306
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2024-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000596361', 'term': 'osimertinib'}, {'id': 'C000718215', 'term': 'amivantamab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2024-07-01', 'studyFirstSubmitQcDate': '2024-07-11', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1)', 'timeFrame': '28 Days', 'description': '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.'}, {'measure': 'Recommended Phase 2 Dose (RP2D) (Part 1)', 'timeFrame': 'up to 30 months', 'description': 'Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D.'}, {'measure': 'Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Parts 2 and 3)', 'timeFrame': 'up to 30 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Concentration-time curve (AUC)', 'timeFrame': 'up to 30 months'}, {'measure': 'Maximum plasma concentration (Cmax)', 'timeFrame': 'up to 30 months'}, {'measure': 'Time to maximum plasma concentration (tmax)', 'timeFrame': 'up to 30 months'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'up to 30 months'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'up to 30 months'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': 'up to 30 months'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'up to 30 months'}, {'measure': 'Time to response (TTR)', 'timeFrame': 'up to 30 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumor, Adult']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT06507306', 'briefTitle': 'A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kumquat Biosciences Inc.'}, 'officialTitle': 'A Phase 1/1b, 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', 'orgStudyIdInfo': {'id': 'KQB198-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Monotherapy Dose Escalation', 'interventionNames': ['Drug: KQB198']}, {'type': 'EXPERIMENTAL', 'label': 'Combo Therapy Dose Escalation', 'interventionNames': ['Drug: KQB198', 'Drug: Osimertinib', 'Drug: Amivantamab']}, {'type': 'EXPERIMENTAL', 'label': 'Combo Therapy Dose Expansion - RP2D', 'interventionNames': ['Drug: KQB198', 'Drug: Osimertinib', 'Drug: Amivantamab']}, {'type': 'EXPERIMENTAL', 'label': 'Combo Therapy Dose Expansion - RP2D-1', 'interventionNames': ['Drug: KQB198', 'Drug: Osimertinib', 'Drug: Amivantamab']}, {'type': 'EXPERIMENTAL', 'label': 'Combo Therapy Dose Expansion OBD', 'interventionNames': ['Drug: KQB198', 'Drug: Osimertinib', 'Drug: Amivantamab']}], 'interventions': [{'name': 'KQB198', 'type': 'DRUG', 'description': 'Oral KQB198', 'armGroupLabels': ['Combo Therapy Dose Escalation', 'Combo Therapy Dose Expansion - RP2D', 'Combo Therapy Dose Expansion - RP2D-1', 'Combo Therapy Dose Expansion OBD', 'Monotherapy Dose Escalation']}, {'name': 'Osimertinib', 'type': 'DRUG', 'otherNames': ['Tagrisso'], 'description': 'Oral Osimertinib', 'armGroupLabels': ['Combo Therapy Dose Escalation', 'Combo Therapy Dose Expansion - RP2D', 'Combo Therapy Dose Expansion - RP2D-1', 'Combo Therapy Dose Expansion OBD']}, {'name': 'Amivantamab', 'type': 'DRUG', 'description': 'Subcutaneous administration', 'armGroupLabels': ['Combo Therapy Dose Escalation', 'Combo Therapy Dose Expansion - RP2D', 'Combo Therapy Dose Expansion - RP2D-1', 'Combo Therapy Dose Expansion OBD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shelby Mosier-Murray', 'role': 'CONTACT', 'email': 'shelby.mosiermurray@sarahcannon.com', 'phone': '720-754-7862'}], 'facility': 'Sarah Cannon Research Institute at HealthONE', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32827', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ingrid Acker', 'role': 'CONTACT', 'email': 'Ingrid.Acker@scri.com', 'phone': '904-380-2414'}], 'facility': 'Sarah Cannon Research Institute at Florida Cancer Specialists - Lake Nona -', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mallory Hawkins', 'role': 'CONTACT', 'email': 'Mallory.Hawkins@flcancer.com', 'phone': '941-377-9993', 'phoneExt': '21654'}], 'facility': 'Florida Cancer Specialists - Sarasota', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeevana Koneru', 'role': 'CONTACT', 'email': 'jkoneru2@hfhs.org', 'phone': '313-725-7857'}], 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '11101', 'city': 'Long Island City', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Navkaran Singh', 'role': 'CONTACT', 'email': 'singhn10@mskcc.org'}], 'facility': 'David H. Koch Center for Cancer Center at Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.74482, 'lon': -73.94875}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Abby Reed', 'role': 'CONTACT', 'email': 'abby.reed@thechristhospital.com', 'phone': '513-585-1140'}], 'facility': 'The Lindner Center for Research and Education at The Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Derrick Porter', 'role': 'CONTACT', 'email': 'Derrick.porter@scri.com', 'phone': '619-982-4133'}], 'facility': 'Sarah Cannon and HCA Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Payton Morel', 'role': 'CONTACT', 'email': 'Pbmorel@mdanderson.org', 'phone': '713-825-7049'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Steven Alvarado', 'role': 'CONTACT', 'email': 'salvarado@nextoncology.com'}], 'facility': 'New Experimental Therapeutics of San Antonio - NEXT Oncology', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aber Lopez', 'role': 'CONTACT', 'email': 'AmberLopez@nextoncology.com', 'phone': '703-565-2881'}], 'facility': 'New Experimental Therapeutics of Virginia - NEXT Oncology', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '13009', 'city': 'Marseille', 'state': 'Bouches-du-Rhône', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Roqiya Nouar', 'role': 'CONTACT', 'email': 'nouarr@ipc.unicancer.fr'}], 'facility': 'Institut Paoli-Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '44800', 'city': 'Saint-Herblain', 'state': 'Loire-Atlantique', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie Toueni', 'role': 'CONTACT', 'email': 'Emilie.Toueni@ico.unicancer.fr', 'phone': '+33 (0)2.40.67.99.00', 'phoneExt': '9508'}], 'facility': "Institut de Cancerologie de l'Ouest - site St-Herblain", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '33000', 'city': 'Bordeaux', 'state': 'Nouvelle-Aquitane', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU Bordeaux - Hopital Saint-Andre', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '31059', 'city': 'Toulouse', 'state': 'Occitaine', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guerin Frederic', 'role': 'CONTACT', 'email': 'Guerin.Frederic@iuct-oncopole.fr'}], 'facility': 'IUCT-Oncopole', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '44000', 'city': 'Nantes', 'state': 'Pays de la Loire Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lucie Ndiaye', 'role': 'CONTACT', 'email': 'lucie.groisard@chu-nantes.fr'}], 'facility': 'CHU de Nantes - Hopital Nord Laennec', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '00168', 'city': 'Rome', 'state': 'Lazio', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Paroni Sterbini', 'role': 'CONTACT', 'email': 'francesco.paronisterbini@policlinicogemelli.it'}], 'facility': 'Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '80131', 'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '10408', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'status': 'WITHDRAWN', 'country': 'South Korea', 'facility': 'National Cancer Center', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '58128', 'city': 'Hwasun', 'state': 'Jeollanam-do', 'status': 'WITHDRAWN', 'country': 'South Korea', 'facility': 'Chonnam National University Hwasun Hospital', 'geoPoint': {'lat': 35.06125, 'lon': 126.98746}}, {'zip': '03722', 'city': 'Seoul', 'state': 'Seoul', 'status': 'WITHDRAWN', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'state': 'Seoul', 'status': 'WITHDRAWN', 'country': 'South Korea', 'facility': "Seoul St. Mary's Hospital, The Catholic University of Korea", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08028', 'city': 'Barcelona', 'state': 'Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Marina Garcia Prat', 'role': 'CONTACT', 'email': 'mgarcia@oncorosell.com'}], 'facility': 'Hospital Universitari Quiron Dexeus Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Paula Barranco', 'role': 'CONTACT', 'email': 'paulabarranco@vhio.net'}], 'facility': "Hospital Universitario Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08023', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Abigail Huerta', 'role': 'CONTACT', 'email': 'ahuerta@nextoncology.eu'}], 'facility': 'New Experimental Therapeutics (NEXT) Oncology Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08023', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rodolfo Fuentes', 'role': 'CONTACT', 'email': 'rodolfo.fuentes@start-barcelona.com'}], 'facility': 'South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28034', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Asier Artazcoz', 'role': 'CONTACT', 'email': 'artazcozec@gmail.com', 'phone': '913368905'}], 'facility': 'Hospital Universitario Ramon y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Silvia Garcia Cuadrado', 'role': 'CONTACT', 'email': 'Silvia.GarciaCuadrado@startmadrid.com'}], 'facility': 'South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28223', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pierpaolo Pisanu', 'role': 'CONTACT', 'email': 'ppisanu@nextoncology.eu'}], 'facility': 'New Experimental Therapeutics (NEXT) Oncology Madrid - Hospital Quironsalud Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria Conesa Garcia-Vera', 'role': 'CONTACT', 'email': 'maria.conesa@startmadrid.com', 'phone': '0034915504800', 'phoneExt': '2201'}], 'facility': 'South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29004', 'city': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Irene Fernandez', 'role': 'CONTACT', 'email': 'irene.fernandezb.co@quironsalud.es'}], 'facility': 'Hospital Quirónsalud Málaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '31008', 'city': 'Pamplona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Eduardo de la Guardia', 'role': 'CONTACT', 'email': 'edelaguardia@unav.es'}], 'facility': 'Clinica Universidad de Navarra - Pamplona', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '73657', 'city': 'Liuying', 'state': 'Tainan City', 'status': 'WITHDRAWN', 'country': 'Taiwan', 'facility': 'Chi-Mei Hospital - Liouying Branch', 'geoPoint': {'lat': 24.44719, 'lon': 118.3877}}, {'zip': '100225', 'city': 'Taipei', 'state': 'Taipei City', 'status': 'WITHDRAWN', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '11217', 'city': 'Taipei', 'state': 'Taiwan', 'status': 'WITHDRAWN', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '40705', 'city': 'Taichung', 'status': 'WITHDRAWN', 'country': 'Taiwan', 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Kumquat Clinical Development', 'role': 'CONTACT', 'email': 'kumquatstudies@kumquatbio.com', 'phone': '(858) 214-2700'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kumquat Biosciences Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}