Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT05438420
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2022-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor Q702 in Combination With Pembrolizumab in Patients With Selected Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-08', 'studyFirstSubmitDate': '2022-05-20', 'studyFirstSubmitQcDate': '2022-06-27', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE', 'timeFrame': 'Up to approximately 2 years (Each Cycle is 42 Days)'}, {'measure': 'Tumor response using RECIST version 1.1 throughout study', 'timeFrame': 'Up to approximately 2 years (Each Cycle is 42 Days)'}], 'secondaryOutcomes': [{'measure': 'Change in the area under curve (AUC) of Q702 and its primary metabolites', 'timeFrame': 'Cycle 1 Day 1 and Day 22 (Each Cycle is 42 Days)'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Cancer', 'Gastric Cancer', 'Hepatocellular Cancer', 'Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a phase 1B/2 open-label, study to determine safety and preliminary efficacy of Q702 in combination with pembrolizumab in study subjects with advanced esophageal, gastric/GEJ, hepatocellular, and cervical cancers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n* Subjects with histologically or cytologically confirmed advanced or metastatic esophageal, gastric/GEJ, hepatocellular and cervical cancers who have progressed on treatment with an anti-PD1 or anti PD-L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other therapies\n* Have measurable disease per RECIST v 1.1. as assessed by local site investigator/radiology\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Life expectancy of at least 3 months\n\nExclusion Criteria:\n\n* A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment or breast-feeding women\n* Concomitant use of strong inhibitors and inducers of CYP1A2, 2J2, 2C19, 2D6, and 3A4/5 within the timeline duration of five half-lives prior to starting study drug and throughout the trial\n* Concomitant use of sensitive substrates of CYP2C9, 2C19, and 3A4 within the timeline duration of five half-lives prior to starting study drug and throughout the trial\n* Has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis\n* Has had an allogeneic tissue/solid organ transplant'}, 'identificationModule': {'nctId': 'NCT05438420', 'briefTitle': 'Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor Q702 in Combination With Pembrolizumab in Patients With Selected Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qurient Co., Ltd.'}, 'officialTitle': 'A Phase 1B/2, Open-label Study of Q702 in Combination With Intravenous Pembrolizumab in Patients With Selected Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'QRNT-008'}, 'secondaryIdInfos': [{'id': 'MK-3475-D35 (KEYNOTE-D35)', 'type': 'OTHER', 'domain': 'Merck Sharp & Dohme LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose escalation of Q702 in combination with fixed dose of pembrolizumab', 'description': 'Give one week on/one week off at selected dose level', 'interventionNames': ['Drug: Q702', 'Biological: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Dose expansion of Q702 in combination with fixed dose of pembrolizumab', 'description': 'Give intravenously once every three week at 200 mg', 'interventionNames': ['Drug: Q702', 'Biological: Pembrolizumab']}], 'interventions': [{'name': 'Q702', 'type': 'DRUG', 'description': 'The study drug Q702 will be administered once daily by mouth on Days 1 through 7, Days 15 through 21 and Days 29 through 35 of every treatment cycle.', 'armGroupLabels': ['Dose escalation of Q702 in combination with fixed dose of pembrolizumab', 'Dose expansion of Q702 in combination with fixed dose of pembrolizumab']}, {'name': 'Pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['KEYTRUDA®'], 'description': 'Pembrolizumab will be administered using IV infusion on Day 1 of each 3-week treatment cycle', 'armGroupLabels': ['Dose escalation of Q702 in combination with fixed dose of pembrolizumab', 'Dose expansion of Q702 in combination with fixed dose of pembrolizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'See Central Contact', 'role': 'CONTACT'}], 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Norton Cancer Institute', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Seongnam-si', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'See Central Contact', 'role': 'CONTACT'}], 'facility': 'CHA Bundang Medical Center', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'See Central Contact', 'role': 'CONTACT'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'See Central Contact', 'role': 'CONTACT'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'See Central Contact', 'role': 'CONTACT'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'See Central Contact', 'role': 'CONTACT'}], 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Qurient Clinical Trial Information', 'role': 'CONTACT', 'email': 'clinicaltrial_info@qurient.com', 'phone': '+82-31-8060-1610'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qurient Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}