Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-27 @ 9:56 PM
Study NCT ID:
NCT06539195
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-12
First Post:
2024-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DZD8586 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (TAI-SHAN9)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2024-08-01', 'studyFirstSubmitQcDate': '2024-08-01', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate assessed by investigators', 'timeFrame': 'Assessed up to 2 years'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': '30 days after the last dose, assessed up to 2 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diffuse Large B Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'This study will treat patients with DLBCL whose disease comes back or is not responding to prior therapy. This study will assess the anti-tumor activity of DZD8586 as monotherapy. It will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants who meet all the following criteria:\n\n1. Male and female ≥ 18 years of age.\n2. ECOG performance status 0-2.\n3. Histologically confirmed recurrent or refractory DLBCL.\n4. Adequate bone marrow reserve and organ system functions.\n5. Willing to comply with contraceptive restrictions\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria:\n\n1. CNS involvement\n2. Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives. Monoclonal antibodies and antibody-drug conjugates within 28 days.\n3. Major surgery or significant traumatic injury within 4 weeks. Live attenuated vaccines or viral vector vaccines within 4 weeks.\n4. Take vitamin K antagonists or take more than 2 anticoagulants or antiplatelet drugs at the same time. Take proton pump inhibitors or strong CYP3A inhibitors or inducers.\n5. Active infection.\n6. Clinically significant cardiac disorders. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months.\n7. Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.\n8. Another malignancy within 2 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer.\n9. Women who are breast feeding.\n10. History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.'}, 'identificationModule': {'nctId': 'NCT06539195', 'briefTitle': 'DZD8586 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (TAI-SHAN9)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dizal Pharmaceuticals'}, 'officialTitle': 'A Phase 2, Open-label, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of DZD8586 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma', 'orgStudyIdInfo': {'id': 'DZ2023B0003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Daily dose of DZD8586 at 25 mg', 'interventionNames': ['Drug: DZD8586']}, {'type': 'EXPERIMENTAL', 'label': 'Daily dose of DZD8586 at 50 mg', 'interventionNames': ['Drug: DZD8586']}, {'type': 'EXPERIMENTAL', 'label': 'Daily dose of DZD8586 at 75 mg', 'interventionNames': ['Drug: DZD8586']}], 'interventions': [{'name': 'DZD8586', 'type': 'DRUG', 'description': 'Daily dose of DZD8586 at 25 mg', 'armGroupLabels': ['Daily dose of DZD8586 at 25 mg']}, {'name': 'DZD8586', 'type': 'DRUG', 'description': 'Daily dose of DZD8586 at 50 mg', 'armGroupLabels': ['Daily dose of DZD8586 at 50 mg']}, {'name': 'DZD8586', 'type': 'DRUG', 'description': 'Daily dose of DZD8586 at 75 mg', 'armGroupLabels': ['Daily dose of DZD8586 at 75 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230031', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '100083', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '530016', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '430023', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '410031', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '250117', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '276002', 'city': 'Linyi', 'state': 'Shandong', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 35.06306, 'lon': 118.34278}}, {'zip': '710061', 'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '300020', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '300181', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Lugui Qiu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dizal Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}