Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2026-01-06 @ 1:46 AM
Study NCT ID:
NCT03155061
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-05
First Post:
2017-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 183}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2017-03-17', 'studyFirstSubmitQcDate': '2017-05-15', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the safety (adverse event, clinical laboratory test, 12-lead electrocardiography, chest X-ray, ECOG performance status)', 'timeFrame': 'Through study completion, an average of 1 year'}], 'secondaryOutcomes': [{'measure': 'Maximum observed serum concentration(Cmax)', 'timeFrame': 'Up to Cycle 1 (each cycle is 28 days)'}, {'measure': 'Area Under the blood concentration-time Curve(AUC)', 'timeFrame': 'Up to Cycle 1 (each cycle is 28 days)'}, {'measure': 'Half-life(T1/2) of ONO-4578 both alone and in combination with ONO-4538', 'timeFrame': 'Up to Cycle 1 (each cycle is 28 days)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced or Metastatic Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '40618725', 'type': 'DERIVED', 'citation': 'Kawazoe A, Yamaguchi K, Hamaguchi T, Narita Y, Boku S, Oshima T, Hara H, Hamamoto Y, Ishido K, Esaki T, Hosaka H, Yasui H, Koeda K, Nishina T, Tsuji Y, Fukagawa T, Goto M, Oki E, Sugimoto N, Matsuoka H, Yokoyama F, Yoshida T, Yoshida K, Oshima Y, Iwasa S. ONO-4578 Plus Nivolumab in Unresectable Advanced or Recurrent Gastric or Gastroesophageal Junction Cancer. Cancer Sci. 2025 Sep;116(9):2523-2536. doi: 10.1111/cas.70130. Epub 2025 Jul 6.'}, {'pmid': '36082616', 'type': 'DERIVED', 'citation': 'Iwasa S, Koyama T, Nishino M, Kondo S, Sudo K, Yonemori K, Yoshida T, Tamura K, Shimizu T, Fujiwara Y, Kitano S, Shimomura A, Sato J, Yokoyama F, Iida H, Kondo M, Yamamoto N. First-in-human study of ONO-4578, an antagonist of prostaglandin E2 receptor 4, alone and with nivolumab in solid tumors. Cancer Sci. 2023 Jan;114(1):211-220. doi: 10.1111/cas.15574. Epub 2022 Nov 4.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the safety, tolerability, pharmacokinetics, efficacy and biomarker of ONO-4578 and combinations of ONO-4578 and ONO-4538 in subjects with advanced or metastatic solid tumors and subjects with unresectable, advanced or recurrent gastric cancer, unresectable, advanced or recurrent colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced or metastatic solid tumors (Part A, B)\n* Unresectable, advanced or recurrent gastric cancer previously treated with anti-PD-(L)1 antibodies or naive to anti-PD-(L)1 antibodies (Part C)\n* Unresectable, advanced or recurrent colorectal cancer(Part D)\n* Life expectancy of at least 3 months\n* Patients with ECOG performance status 0 or 1\n\nExclusion Criteria:\n\n* Patients with severe complication\n* Patients with multiple primary cancers'}, 'identificationModule': {'nctId': 'NCT03155061', 'briefTitle': 'Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ono Pharmaceutical Co. Ltd'}, 'officialTitle': 'Phase 1 Dose Escalating and Expansion Study of ONO-4578 Given as Monotherapy and Combinations of ONO-4578 and ONO-4538 in Subjects With Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'ONO-4578-01'}, 'secondaryIdInfos': [{'id': 'jRCT2080223441', 'type': 'REGISTRY', 'domain': 'Japan Registry of Clinical Trials'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A (Dose Escalation Part): ONO-4578 monotherapy', 'description': 'ONO-4578 specified dose on specified days in advanced or metastatic solid tumors', 'interventionNames': ['Drug: ONO-4578']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: ONO-4578 in combination with ONO-4538', 'description': 'ONO-4578+ONO-4538 specified dose on specified days in advanced or metastatic solid tumors', 'interventionNames': ['Drug: ONO-4578', 'Drug: ONO-4538']}, {'type': 'EXPERIMENTAL', 'label': 'Part C (Expansion Part): ONO-4578 in combination with ONO-4538', 'description': 'ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent gastric cancer', 'interventionNames': ['Drug: ONO-4578', 'Drug: ONO-4538']}, {'type': 'EXPERIMENTAL', 'label': 'Part D (Expansion Part): ONO-4578 in combination with ONO-4538', 'description': 'ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent colorectal cancer', 'interventionNames': ['Drug: ONO-4578', 'Drug: ONO-4538']}], 'interventions': [{'name': 'ONO-4578', 'type': 'DRUG', 'description': 'ONO-4578 specified dose on specified days', 'armGroupLabels': ['Part A (Dose Escalation Part): ONO-4578 monotherapy', 'Part B: ONO-4578 in combination with ONO-4538', 'Part C (Expansion Part): ONO-4578 in combination with ONO-4538', 'Part D (Expansion Part): ONO-4578 in combination with ONO-4538']}, {'name': 'ONO-4538', 'type': 'DRUG', 'description': 'ONO-4538 specified dose on specified days', 'armGroupLabels': ['Part B: ONO-4578 in combination with ONO-4538', 'Part C (Expansion Part): ONO-4578 in combination with ONO-4538', 'Part D (Expansion Part): ONO-4578 in combination with ONO-4538']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Aichi Clinical Site 1', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Toyoake', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Aichi Clinical Site 2', 'geoPoint': {'lat': 35.038, 'lon': 136.99931}}, {'city': 'Kashiwa', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Chiba Clinical Site 1', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}, {'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'facility': 'Ehime Clinical Site1', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Ōta', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Gunma Clinical Site 1', 'geoPoint': {'lat': 36.3, 'lon': 139.36667}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Hokkaido Clinical Site 1', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Yahaba-cho', 'state': 'Iwate', 'country': 'Japan', 'facility': 'Iwate Clinical Site 1'}, {'city': 'Sagamihara', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Kanagawa Clinical Site 2', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Kanagawa Clinical Site 1', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Hirakata', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Clinical Site 2', 'geoPoint': {'lat': 34.81352, 'lon': 135.64914}}, {'city': 'Sakai', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Clinical Site 3', 'geoPoint': {'lat': 34.58216, 'lon': 135.46653}}, {'city': 'Takatsuki', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Clinical Site 4', 'geoPoint': {'lat': 34.84833, 'lon': 135.61678}}, {'city': 'Hidaka', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Clinical Site 2', 'geoPoint': {'lat': 35.91664, 'lon': 139.36233}}, {'city': 'Ina-machi', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Clinical Site 1'}, {'city': 'Nagaizumi-Cho', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Shizuoka Clinical Site 1'}, {'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Clinical Site 1'}, {'city': 'Itabashi-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Clinical Site 4'}, {'city': 'Koto-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Clinical Site 2'}, {'city': 'Shinjyuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Clinical Site 3'}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Fukuoka Clinical Site 1', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Fukuoka Clinical Site 2', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Clinical Site 1', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], 'overallOfficials': [{'name': 'Project Leader', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ono Pharmaceutical Co. Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ono Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}