Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT06234605
Status:
RECRUITING
Last Update Posted:
2024-11-22
First Post:
2024-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720612', 'term': 'belzutifan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2024-01-09', 'studyFirstSubmitQcDate': '2024-01-29', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of MTD and RP2D (combination cohorts only)', 'timeFrame': '30 months', 'description': 'To identify the maximum tolerated dose (MTD) and/ or recommended Phase 2 dose (RP2D), and evaluate the safety, tolerability and dose-limiting toxicities (DLTs) of HC-7366 in combination with belzutifan in patients with locally advanced (inoperable) or metastatic RCC with predominantly clear cell histology irrespective of VHL gene mutation status'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ccRCC', 'belzutifan', 'kidney cancer', 'metastatic', 'locally advanced', 'HC-7366', 'WELIREG™'], 'conditions': ['Renal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1b, open-label, multicenter, safety, tolerability and efficacy study of HC-7366 in combination with belzutifan (WELIREG™). This is a multipart study that consists of a HC-7366 monotherapy cohort, a combination dose escalation, and a combination dose expansion. Approximately 80 patients will be enrolled in this study (up to 20 patients will be enrolled into the HC-7366 monotherapy cohort, up to 30 patients into the combination dose escalation, and up to 30 patients into the combination dose expansion). The primary purpose of this study is to determine the maximum tolerated dose of HC-7366 in combination with belzutifan in patients with locally advanced (inoperable) or metastatic RCC with predominantly clear cell histology, irrespective of VHL gene mutation status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has diagnosis of locally advanced (inoperable) or metastatic RCC with a predominant clear cell component\n* Be age 18 years or older (male or female) at the time of consent'}, 'identificationModule': {'nctId': 'NCT06234605', 'briefTitle': 'A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'HiberCell, Inc.'}, 'officialTitle': 'A Phase 1b, Open-Label, Safety, Tolerability, and Efficacy Study of HC- 7366 in Combination With Belzutifan (WELIREG™) in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': 'HC366-RCC2311'}, 'secondaryIdInfos': [{'id': 'MK-6482-030', 'type': 'OTHER', 'domain': 'Merck Sharp & Dohme LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Monotherapy', 'description': 'Participants will receive HC-7366 monotherapy \\[dose to be determined\\] daily', 'interventionNames': ['Drug: HC-7366']}, {'type': 'EXPERIMENTAL', 'label': 'Combination', 'description': 'Participants will receive HC-7366 monotherapy \\[dose to be determined\\] in combination with belzutifan \\[120 mg\\] daily', 'interventionNames': ['Drug: HC-7366', 'Drug: Belzutifan']}], 'interventions': [{'name': 'HC-7366', 'type': 'DRUG', 'description': 'HC-7366 is a novel, orally administered, highly selective and potent general control nonderepressible 2 (GCN2) kinase activator.', 'armGroupLabels': ['Combination', 'Monotherapy']}, {'name': 'Belzutifan', 'type': 'DRUG', 'otherNames': ['WELIREG™', 'MK-6482'], 'description': 'Belzutifan is a potent and selective HIF-2α inhibitor', 'armGroupLabels': ['Combination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Thomas Schlaback', 'role': 'CONTACT', 'email': 'thomas2020@arizona.edu', 'phone': '520-694-9090'}, {'name': 'Cindie Neal', 'role': 'CONTACT', 'email': 'cyndieneal@arizona.edu', 'phone': '520-626-6954'}], 'facility': 'University of Arizona Cancer Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Karen Cuervo', 'role': 'CONTACT', 'email': 'kcuervo@health.ucsd.edu'}], 'facility': 'University of California San Diego Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Linda Ford', 'role': 'CONTACT', 'email': 'linda.ford@cshs.org'}], 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80124', 'city': 'Lone Tree', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bobbie Donnachaidh', 'role': 'CONTACT', 'email': 'bobbie.donnachaidh@usoncology.com'}, {'name': 'Jennifer Hege', 'role': 'CONTACT', 'email': 'jennifer.hege@usoncology.com'}], 'facility': 'Rocky Mountain Cancer Centers, LLP', 'geoPoint': {'lat': 39.55171, 'lon': -104.8863}}, {'zip': '55101', 'city': 'Saint Paul', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Octav Pacurar', 'role': 'CONTACT', 'email': 'Octav.Pacurar@ParkNicollet.com'}], 'facility': 'HealthPartners Cancer Research Center', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joel Picus', 'role': 'CONTACT'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rachel Jacobi', 'role': 'CONTACT', 'email': 'jacobir@mskcc.org'}], 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kathryn Helminiak', 'role': 'CONTACT', 'email': 'kathryn.helminiak@UHhospitals.org'}], 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Lynn', 'role': 'CONTACT', 'email': 'lynnd4@ccf.org'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katrina Herz', 'role': 'CONTACT', 'email': 'Katrina.Herz@providence.org'}], 'facility': 'Providence Cancer Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emma Brennan', 'role': 'CONTACT', 'email': 'Emma.Brennan@scri.com'}, {'name': 'Lauren King', 'role': 'CONTACT', 'email': 'Lauren.King@scri.com'}], 'facility': 'SCRI Oncology Partners', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lisa Jones', 'role': 'CONTACT', 'email': 'lisa.jones1@usoncology.com'}], 'facility': 'Texas Oncology', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Janice Alcaide', 'role': 'CONTACT', 'email': 'janice.alcaide@usoncology.com', 'phone': '703-208-3771'}, {'name': 'Karina Castillo Grady', 'role': 'CONTACT', 'email': 'karina.castillogrady@usoncology.com', 'phone': '571-350-8758'}], 'facility': 'Virginia Cancer Specialists', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kim Reeves', 'role': 'CONTACT', 'email': 'kimberly.reeves@swedish.org', 'phone': '206-337-3851'}, {'name': 'Anna Pannick', 'role': 'CONTACT', 'email': 'Anna.Pannick@Swedish.org', 'phone': '206-386-3142'}], 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'UW Cancer Connect', 'role': 'CONTACT', 'email': 'clinicaltrials@cancer.wisc.edu', 'phone': '608-262-0439'}], 'facility': 'University of Wisconsin - Carbone Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'centralContacts': [{'name': 'Megan Holm', 'role': 'CONTACT', 'email': 'mholm@hibercell.com', 'phone': '651-675-0300'}, {'name': 'Paulette Mattson', 'role': 'CONTACT', 'email': 'pmattson@hibercell.com', 'phone': '651-675-0300'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HiberCell, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}