Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2026-01-13 @ 9:27 AM
Study NCT ID:
NCT06547528
Status:
RECRUITING
Last Update Posted:
2025-06-03
First Post:
2024-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'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': 'D007938', 'term': 'Leukemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-01', 'studyFirstSubmitDate': '2024-08-01', 'studyFirstSubmitQcDate': '2024-08-07', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicities(DLT)', 'timeFrame': 'Up to 3 Weeks'}, {'measure': 'Incidence and severity of AEs and SAEs', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Laboratory abnormality profile of ONO-4685 as measured by incidence and severity of clinical laboratory abnormalities', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Body temperature', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Pulse rate', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Systolic/diastolic blood pressure', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Change of weight during the trial period', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Chest X-ray test', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'ECG parameters by 12 lead ECG(pulse rate)', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'ECG parameters by 12 lead ECG(RR)', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'ECG parameters by 12 lead ECG(QT interval)', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'ECG parameters by 12 lead ECG(corrected QT intervals [QTcF, QTcB])', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'ECG parameters by 12 lead ECG(PR interval)', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'ECG parameters by 12 lead ECG(QRS)', 'timeFrame': 'Through study completion, an average of 1 year'}], 'secondaryOutcomes': [{'measure': 'Best overall response (BOR)', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Complete response rate (CRR)', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Progression Free Survival(PFS)', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Time to response (TTR)', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Overall Survival(OS)', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'The percent change of tumor volume', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Pharmacokinetics(Cmax)', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Pharmacokinetics(Tmax)', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Pharmacokinetics(AUC)', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Pharmacokinetics(Ceoi)', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Pharmacokinetics(T1/2)', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Pharmacokinetics(Ctrough)', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Volume of distribution(Vd)', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'clearance(CL)', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Anti-ONO-4685 antibody', 'timeFrame': 'Through study completion, an average of 1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma']}, 'descriptionModule': {'briefSummary': 'A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with histopathologically confirmed diagnosis of one of the following subtypes as defined by the 2017 revision of the WHO classification of lymphoid malignancies:\n\n Peripheral T-cell lymphoma(PTCL)\n * Angioimmunoblastic T-cell lymphoma(AITL)\n * Peripheral T-cell lymphoma, NOS(PTCL-NOS)\n * Nodal peripheral T-cell lymphoma with TFH phenotype(nodal PTCL with TFH)\n * Follicular T-cell lymphoma(FTCL) Cutaneous T-cell lymphoma(CTCL)\n * Mycosis fungoides(MF)\n * Sezary syndrome Chronic lymphocytic leukemia/small lymphocytic lymphoma(CLL/SLL)\n2. Relapsed or refractory patients with tumors for which no established standard therapy is available, or refractory or intolerant to existing standard therapy judged by principal investigator or subinvestigator\n3. ECOG PS 0\\~2\n4. Life expectancy of at least 3 months\n\nExclusion Criteria:\n\n1. Patients with severe complications.\n2. Patients with multiple cancers.'}, 'identificationModule': {'nctId': 'NCT06547528', 'briefTitle': 'A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ono Pharmaceutical Co. Ltd'}, 'officialTitle': 'An Open-label, Uncontrolled, Phase I Dose Escalation Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in Patients With Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)', 'orgStudyIdInfo': {'id': 'ONO-4685-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ONO-4685', 'interventionNames': ['Drug: ONO-4685']}], 'interventions': [{'name': 'ONO-4685', 'type': 'DRUG', 'description': 'ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed.', 'armGroupLabels': ['ONO-4685']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nagoya', 'state': 'Aichi-ken', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Aichi Cancer Center Hospital', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Nagoya', 'state': 'Aichi-ken', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Nagoya University Hospital', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Akita', 'state': 'Akita', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Akita University Hospital', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'city': 'Kashiwa-shi', 'state': 'Chiba', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'National Cancer Center Hospital East'}, {'city': 'Fukuoka', 'state': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Kyushu University Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Hokkaido University Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Isehara-shi', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Tokai University Hospital'}, {'city': 'Kumamoto', 'state': 'Kumamoto', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Kumamoto University Hospital', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Kyoto', 'state': 'Kyoto', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'University Hospital Kyoto Prefectural University of Medicine', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Sendai', 'state': 'Miyagi', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Tohoku University Hospital', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Okayama', 'state': 'Okayama-ken', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Okayama University Hospital', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Osaka Sayama-shi', 'state': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Kindai University Hospital'}, {'city': 'Osaka-fu', 'state': 'Osaka', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'facility': 'Osaka University Hospital'}, {'city': 'Koto-ku', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Cancer Institute Hospital of JFCR'}], 'centralContacts': [{'name': 'North America Clinical Trial Support Desk', 'role': 'CONTACT', 'email': 'clinical_trial@ono-pharma.com', 'phone': '+18665877745(Toll-Free)'}, {'name': 'International Clinical Trial Support Desk', 'role': 'CONTACT', 'email': 'clinical_trial@ono-pharma.com', 'phone': '+17162141777(Standard)'}], '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'}}}}