Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-31 @ 6:14 AM
Study NCT ID:
NCT06540261
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study of ONO-7913, ONO-4538 and the Standard of Care as First-line Treatment in Patients Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629291', 'term': 'magrolimab'}, {'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000068818', 'term': 'Cetuximab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-09', 'studyFirstSubmitDate': '2024-08-01', 'studyFirstSubmitQcDate': '2024-08-01', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicities（DLT）', 'timeFrame': '28 days'}, {'measure': 'Adverse event (AE)', 'timeFrame': 'Up to 30 days after the last dose'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics（Plasma concentration of ONO-7913）', 'timeFrame': 'Through study completion, an average of 1 year.'}, {'measure': 'Pharmacokinetics（Plasma concentration of ONO-4538）', 'timeFrame': 'Through study completion, an average of 1 year.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Through study completion, an average of 1 year.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Through study completion, an average of 1 year.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Through study completion, an average of 3 years.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Through study completion, an average of 1 years.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Through study completion, an average of 1 years.'}, {'measure': 'Time to Response (TTR)', 'timeFrame': 'Through study completion, an average of 1 years.'}, {'measure': 'Best Overall Response (BOR)', 'timeFrame': 'Through study completion, an average of 1 years.'}, {'measure': 'Percent change in the sum diameters of the target lesions', 'timeFrame': 'Through study completion, an average of 1 years.'}, {'measure': 'Maximum percent change in the sum diameters of the target lesions', 'timeFrame': 'Through study completion, an average of 1 years.'}, {'measure': 'Early Tumor shrinkage（ETS）', 'timeFrame': 'Up to 8 weeks'}, {'measure': 'Change From Baseline in Tumour Biomarkers (CEA and CA19-9)', 'timeFrame': 'Through study completion, an average of 1 year.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Unresectable Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'To confirm the tolerability and safety of combined administration of ONO-7913, ONO-4538 and the standard of care FOLFOX in combination with bevacizumab or cetuximab as first-line treatment in patients with unresectable advanced or recurrent colorectal cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Unresectable advanced or recurrent colorectal cancer\n2. Life expectancy of at least 3 months\n3. Patients with ECOG performance status 0 or 1\n\nExclusion Criteria:\n\n1. Patients with severe complication\n2. Patients with multiple primary cancers'}, 'identificationModule': {'nctId': 'NCT06540261', 'briefTitle': 'The Study of ONO-7913, ONO-4538 and the Standard of Care as First-line Treatment in Patients Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ono Pharmaceutical Co. Ltd'}, 'officialTitle': 'An Open-label, Uncontrolled Study of ONO-7913, ONO-4538 and the Standard of Care FOLFOX in Combination With Bevacizumab or Cetuximab as First-line Treatment in Patients With Unresectable Advanced or Recurrent Colorectal Cancer', 'orgStudyIdInfo': {'id': 'ONO-7913-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ONO-7913＋ONO-4538＋FOLFOX＋Bev', 'interventionNames': ['Drug: ONO-7913', 'Drug: ONO-4538', 'Drug: Fluorouracil', 'Drug: Oxaliplatin', 'Drug: Levofolinate', 'Drug: Bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': 'ONO-7913＋ONO-4538＋FOLFOX＋Cet', 'interventionNames': ['Drug: ONO-7913', 'Drug: ONO-4538', 'Drug: Fluorouracil', 'Drug: Oxaliplatin', 'Drug: Levofolinate', 'Drug: Cetuximab']}], 'interventions': [{'name': 'ONO-7913', 'type': 'DRUG', 'otherNames': ['Magrolimab'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['ONO-7913＋ONO-4538＋FOLFOX＋Bev', 'ONO-7913＋ONO-4538＋FOLFOX＋Cet']}, {'name': 'ONO-4538', 'type': 'DRUG', 'otherNames': ['Nivolumab'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['ONO-7913＋ONO-4538＋FOLFOX＋Bev', 'ONO-7913＋ONO-4538＋FOLFOX＋Cet']}, {'name': 'Fluorouracil', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['ONO-7913＋ONO-4538＋FOLFOX＋Bev', 'ONO-7913＋ONO-4538＋FOLFOX＋Cet']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['ONO-7913＋ONO-4538＋FOLFOX＋Bev', 'ONO-7913＋ONO-4538＋FOLFOX＋Cet']}, {'name': 'Levofolinate', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['ONO-7913＋ONO-4538＋FOLFOX＋Bev', 'ONO-7913＋ONO-4538＋FOLFOX＋Cet']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['ONO-7913＋ONO-4538＋FOLFOX＋Bev']}, {'name': 'Cetuximab', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['ONO-7913＋ONO-4538＋FOLFOX＋Cet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toyoake', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Fujita Health University Hospital', 'geoPoint': {'lat': 35.038, 'lon': 136.99931}}, {'city': 'Kashiwa', 'state': 'Chiba', 'country': 'Japan', 'facility': 'National Cancer Center Hospital East', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Hokkaido University Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Kobe City Medical Center General Hospital', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'city': 'Kawasaki', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'St. Marianna University Hospital', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Kanagawa Cancer Center', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Kurashiki', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Kurashiki Central Hospital', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}, {'city': 'Hirakata', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Kansai Medical University Hospital', 'geoPoint': {'lat': 34.81352, 'lon': 135.64914}}, {'city': 'Takatsuki', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Medical and Pharmaceutical University Hospital', 'geoPoint': {'lat': 34.84833, 'lon': 135.61678}}, {'city': 'Hidaka', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Medical University International Medical Center', 'geoPoint': {'lat': 35.91664, 'lon': 139.36233}}, {'city': 'Shinden', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Cancer Center', 'geoPoint': {'lat': 35.99971, 'lon': 139.62486}}, {'city': 'Koto-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Cancer Institute Hospital of JFCR'}, {'city': 'Chūōku', 'state': 'Toyko', 'country': 'Japan', 'facility': 'National Cancer Center Hospital', 'geoPoint': {'lat': 33.63867, 'lon': 130.67068}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Chiba Cancer Center', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'National Hospital Organization Osaka National Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka General Medical Center', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka International Cancer Institute', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ono Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}