Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-30 @ 6:41 PM
Study NCT ID:
NCT05394103
Status:
RECRUITING
Last Update Posted:
2025-08-17
First Post:
2022-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2022-05-19', 'studyFirstSubmitQcDate': '2022-05-23', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': '28 days of cycle 1 (each cycle is 28 days)'}], 'secondaryOutcomes': [{'measure': 'Change in the area under curve (AUC) of Q901', 'timeFrame': 'Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)'}, {'measure': 'Change in the maximum plasma concentration (Cmax) of Q901', 'timeFrame': 'Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)'}, {'measure': 'Change in the time of maximum plasma concentration (Tmax) of Q901', 'timeFrame': 'Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)'}, {'measure': 'Tumor response using RECIST version 1.1 throughout study', 'timeFrame': 'Baseline and at the end of every even cycle up to approximately 2 years (each cycle is 28 days)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Cancer', 'Metastatic Cancer']}, 'descriptionModule': {'briefSummary': 'Multicenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901 as a monotherapy and in combination with pembrolizumab'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants with histologically or cytologically confirmed advanced or metastatic ovarian, CRPC, HR+ HER2- breast, endometrial, colorectal, small-cell lung, or pancreatic cancer, who have progressed following standard-of-care therapy or for whom there is no standard therapy that confers clinical benefit\n* Measurable disease per RECIST v 1.1\n* ECOG performance status 0,1 or 2\n* Life expectancy of at least 3 months\n* Age ≥ 18 years\n* Signed, written IRB-approved informed consent form\n\nExclusion Criteria:\n\n* New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, congestive heart failure within the past 6 months\n* Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of \\>470 msec (females) and \\>450 msec (males)\n* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy\n* Active, poorly controlled autoimmune or inflammatory diseases"}, 'identificationModule': {'nctId': 'NCT05394103', 'briefTitle': 'Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qurient Co., Ltd.'}, 'officialTitle': 'A Phase 1/2 Multicenter, Open-label, Dose-escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of Q901Administered Via Intravenous Infusion as Monotherapy and in Combination With Pembrolizumab in Adult Patients With Selected Advanced Solid Tumors With Cohort Expansions at the Recommended Phase 2 Dose', 'orgStudyIdInfo': {'id': 'QRNT-009'}, 'secondaryIdInfos': [{'id': 'MK-3475-E45 (KEYNOTE-E45)', 'type': 'OTHER', 'domain': 'Merck Sharp & Dohme LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose escalation (Q901)', 'interventionNames': ['Drug: Q901']}, {'type': 'EXPERIMENTAL', 'label': 'Q901 Single-Agent Expansion Cohorts', 'interventionNames': ['Drug: Q901']}, {'type': 'EXPERIMENTAL', 'label': 'Q901 + KEYTRUDA® (pembrolizumab) Cohorts', 'interventionNames': ['Drug: Q901', 'Drug: KEYTRUDA® (pembrolizumab)']}], 'interventions': [{'name': 'Q901', 'type': 'DRUG', 'description': 'The study drug Q901 will be administered by IV infusion over a 30-minute period using a QW dosing schedule for 4 weeks, followed by a Q2W interval dosing schedule thereafter', 'armGroupLabels': ['Dose escalation (Q901)', 'Q901 + KEYTRUDA® (pembrolizumab) Cohorts', 'Q901 Single-Agent Expansion Cohorts']}, {'name': 'KEYTRUDA® (pembrolizumab)', 'type': 'DRUG', 'description': 'KEYTRUDA® (pembrolizumab) will be administered Q6W', 'armGroupLabels': ['Q901 + KEYTRUDA® (pembrolizumab) Cohorts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'See Central Contact', 'role': 'CONTACT'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'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': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'See Central Contact', 'role': 'CONTACT'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'See Central Contact', 'role': 'CONTACT'}], 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'See Central Contact', 'role': 'CONTACT'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'See Central Contact', 'role': 'CONTACT'}], 'facility': 'Atlantic Health System Hospital', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'See Central Contact', 'role': 'CONTACT'}], 'facility': 'Mary Crowley Cancer Research', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Goyang-si', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'See Central Contact', 'role': 'CONTACT'}], 'facility': 'National Cancer Center', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'city': 'Seongnam-si', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'See Central Contact', 'role': 'CONTACT'}], 'facility': 'CHA University 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': 'NOT_YET_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'}}}}