Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-01-01 @ 2:29 AM
Study NCT ID:
NCT06994806
Status:
RECRUITING
Last Update Posted:
2025-07-11
First Post:
2025-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Safety and Efficacy of KQB168 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': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2025-05-12', 'studyFirstSubmitQcDate': '2025-05-20', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who experience treatment-emergent adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)', 'timeFrame': 'up to 36 months', '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 30 days after last dose of study treatment.'}], 'secondaryOutcomes': [{'measure': 'Overall response rate (ORR)', 'timeFrame': 'up to 36 months', 'description': 'Using RECIST v1.1'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'up to 36 months', 'description': 'Using RECIST v1.1'}, {'measure': 'Time to response (TTR)', 'timeFrame': 'up to 36 months', 'description': 'Using RECIST v1.1'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'up to 36 months', 'description': 'Using RECIST v1.1'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'up to 36 months', 'description': 'Using RECIST v1.1'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'up to 36 months', 'description': 'using RECIST v1.1'}, {'measure': 'Concentration-time curve (AUC)', 'timeFrame': 'up to 36 months'}, {'measure': 'Maximum plasma concentration (Cmax)', 'timeFrame': 'up to 36 months'}, {'measure': 'Time to maximum plasma concentration (tmax)', 'timeFrame': 'up to 36 months'}, {'measure': 'Pharmacologically Active Dose (PAD)', 'timeFrame': 'up to 36 months', 'description': 'Assessment of tumor and systemic immune activation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumor Malignancies']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT06994806', 'briefTitle': 'A Study to Investigate the Safety and Efficacy of KQB168 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kumquat Biosciences Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'KQB168-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Monotherapy Dose Escalation', 'description': 'Drug: KQB168 - Oral KQB168', 'interventionNames': ['Drug: KQB168']}, {'type': 'EXPERIMENTAL', 'label': 'Combo Therapy Dose Escalation', 'description': 'Drug: KQB168 - Oral KQB168 Drug: pembrolizumab - Intravenous pembrolizumab', 'interventionNames': ['Drug: KQB168', 'Drug: Pembrolizumab']}], 'interventions': [{'name': 'KQB168', 'type': 'DRUG', 'description': 'Oral KQB168', 'armGroupLabels': ['Combo Therapy Dose Escalation', 'Monotherapy Dose Escalation']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'description': 'Intravenous pembrolizumab', 'armGroupLabels': ['Combo Therapy Dose Escalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78758', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Heather Watson', 'role': 'CONTACT', 'email': 'hwatson@nextoncology.com', 'phone': '737-610-5202'}], 'facility': 'NEXT Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emma Morales', 'role': 'CONTACT', 'email': 'emorales@nextoncology.com', 'phone': '(832) 384-7912'}], 'facility': 'NEXT Huston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jordan Georg', 'role': 'CONTACT', 'email': 'jgeorg@nextoncology.com', 'phone': '(210) 580-9521'}], 'facility': 'NEXT Oncology', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Referral Coordinator', 'role': 'CONTACT', 'email': 'mdelarosa@nextoncology.com', 'phone': '(703) 783-4518'}], 'facility': 'NEXT Virginia', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}], 'centralContacts': [{'name': 'Kumquat Clinical Development', 'role': 'CONTACT', 'email': 'kumquatstudies@kumquatbio.com', 'phone': '(858) 214-2700'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kumquat Biosciences Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}