Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-29 @ 5:56 PM
Study NCT ID:
NCT05515406
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-19
First Post:
2022-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of ONO-7018 in Patients With R/R NHL or CLL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D007938', 'term': 'Leukemia'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-16', 'studyFirstSubmitDate': '2022-08-18', 'studyFirstSubmitQcDate': '2022-08-23', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimate of Maximum Tolerated Dose (MTD)', 'timeFrame': 'Up to 3 weeks', 'description': 'MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment'}, {'measure': 'Incidence, causality, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Adverse events with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 used as a guide for the grading of severity.'}], 'secondaryOutcomes': [{'measure': 'Plasma Concentration of ONO-7018', 'timeFrame': 'Up to 48 weeks', 'description': 'Plasma concentration will be assessed to evaluate Pharmacokinetics'}, {'measure': 'Antitumor Activity of ONO-7018 (Overall Response Rate [ORR])', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Antitumor activity of ONO-7018 as measured by ORR will be assessed according to the response criteria for Lymphoma.Lymphoma.'}, {'measure': 'Antitumor Activity of ONO-7018 (Duration of Response [DOR])', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Antitumor activity of ONO-7018 as measured by DOR will be assessed according to the response criteria for Lymphoma.'}, {'measure': 'Antitumor Activity of ONO-7018 (Progression Free Survival [PFS])', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Antitumor activity of ONO-7018 as measured by PFS will be assessed according to the response criteria for Lymphoma.'}, {'measure': 'Antitumor Activity of ONO-7018 (Overall Survival [OS])', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Antitumor activity of ONO-7018 as measured by OS will be assessed.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ONO-7018, MALT1 inhibitor, Lymphoma, Leukemia'], 'conditions': ['Lymphoma, Non-Hodgkin', 'Leukemia, Lymphocytic, Chronic, B-Cell']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, open-label, multicenter study. This will be the first-in-human clinical study for ONO-7018 and will be conducted in two phases: a Dose Escalation Phase (Part 1) and a Dose Expansion Phase (Part 2).', 'detailedDescription': 'ONO-7018 is a selective inhibitor of mucosa associated lymphoid tissue protein 1 (MALT1) and is expected to exhibit antitumor activity in NHL and CLL. The purpose of this study is to determine the MTD and to evaluate the safety, tolerability, PK, pharmacodynamics (biomarkers), and efficacy of ONO-7018 in patients with relapsed or refractory NHL or CLL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient aged ≥ 18 years\n2. Written informed consent by the patient or the patient's legally authorized representative\n3. Patient with histologically/cytologically confirmed diagnosis of NHL or CLL\n4. Patient with relapsed or refractory disease who has no available therapeutic options known to provide clinical benefit\n5. Patient who has measurable disease\n6. All acute toxic effects of any prior antitumor therapy, including investigational therapy, resolved to Grade ≤ 1 before the start of study therapy\n7. Eastern Cooperative Oncology Group Performance Status 0 to 2\n8. Adequate bone marrow, renal and hepatic functions\n\nExclusion Criteria:\n\n1. History of lymphoid malignancy other than those allowed per inclusion criteria\n2. Patient with central nervous system involvement\n3. Patient with systemic and active infection\n4. Any serious or uncontrolled medical disorder that may increase the risk associated with study participation or study treatment, or interfere with the interpretation of study results\n5. Prior treatment with a MALT1 inhibitor\n6. Patient receiving any other investigational drug within 4 weeks prior to study entry\n7. Patient is unable to swallow tablets\n8. Patient is found to be otherwise ineligible for the study by the investigator or sub investigator"}, 'identificationModule': {'nctId': 'NCT05515406', 'briefTitle': 'A Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of ONO-7018 in Patients With R/R NHL or CLL', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ono Pharmaceutical Co. Ltd'}, 'officialTitle': 'A Phase I, Open-label, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ONO-7018 in Patients With Relapsed or Refractory NHL or CLL', 'orgStudyIdInfo': {'id': 'ONO-7018-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation Phase (Part 1)', 'description': 'Up to 4 dose levels will be evaluated. Eligible patients will be assigned to a dose level cohort according to a traditional 3+3 dose escalation design.', 'interventionNames': ['Drug: ONO-7018']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion Phase (Part 2)', 'description': 'Eligible patients will be assigned to the recommended dose level(s) selected from Part 1.', 'interventionNames': ['Drug: ONO-7018']}], 'interventions': [{'name': 'ONO-7018', 'type': 'DRUG', 'description': 'ONO-7018 tablet(s) are administered orally', 'armGroupLabels': ['Dose Escalation Phase (Part 1)']}, {'name': 'ONO-7018', 'type': 'DRUG', 'description': 'ONO-7018 tablet(s) are administered orally', 'armGroupLabels': ['Dose Expansion Phase (Part 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '64114', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'AMR Kansas City', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '27858', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Leo Jenkins Cancer Center/ECU School of Medicine', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott & White Research Institute', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Medical Specialities', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'Project Leader', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ono Pharma USA Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ono Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}