Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT05113069
Status:
UNKNOWN
Last Update Posted:
2023-12-06
First Post:
2021-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of SHR-A1912 for Injection in Patients With B Cell Lymphomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}], 'ancestors': [{'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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'single arm for SHR-A1912'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2021-11-05', 'studyFirstSubmitQcDate': '2021-11-05', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '21 Days after the 1st dosing (first cycle)'}, {'measure': 'Dose Limited Toxicity (DLT)', 'timeFrame': '21 Days (first cycle)'}, {'measure': 'Maximum tolerable dose (MTD)', 'timeFrame': '21 Days (first cycle)'}, {'measure': 'Recommended phase II dose (RP2D)', 'timeFrame': 'Up to approximately 2 years'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '12 weeks after the last dose'}, {'measure': 'Time of maximum observed plasma concentration (Tmax) of SHR-1912', 'timeFrame': '21 days after last dose'}, {'measure': 'Maximum observed plasma concentration (Cmax) of SHR-1912', 'timeFrame': '21 days after last dose'}, {'measure': 'Area under the plasma concentration time curve (AUC) of SHR-1912', 'timeFrame': '21 days after last dose'}, {'measure': 'Anti-drug antibody (ADA) of SHR-A1912', 'timeFrame': '12 weeks after last dose'}, {'measure': 'Complete Response Rate (CR)', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 3 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['B Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'To assess the safety and tolerability of SHR-A1912 in patients with B cell lymphoma, to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of SHR-A1912.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age greater than or equal to18 years old, male or female;\n2. Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1;\n3. Life expectancy \\>12 weeks;\n4. Histologically or cytologically confirmed B cell lymphoma;\n5. Relapsed and/or refractory disease after at least 1 prior treatment regimen;\n6. At least one measurable nodal lesion, defined as \\> 1.5 cm in its longest dimension, or one measurable extra nodal lesion, defined as \\> 1.0 cm in its longest diameter (no need for dose escalation stage).\n\nExclusion Criteria:\n\n1. Received autologous stem cell transplantation within 12 weeks before the first study treatment; previously received allogeneic stem cell transplantation; received Car-T cell therapy within 12 weeks before the first study treatment;\n2. History of recent major surgery or severe trauma within 4 weeks before the first study treatment;\n3. Received anti-tumour treatment within 2 weeks before the first study treatment;\n4. Central nervous system (CNS) infiltration;\n5. Active infection with HBV or HCV;\n6. History of immunodeficiency, including HIV serotest positive, or other acquired or congenital immunodeficiency diseases, and active tuberculosis;\n7. Active infection or unexplained fever\\>38.5℃;\n8. History of severe cardiovascular disease.'}, 'identificationModule': {'nctId': 'NCT05113069', 'briefTitle': 'A Study of SHR-A1912 for Injection in Patients With B Cell Lymphomas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Hengrui Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1912 for Injection as Monotherapy in Patients With B-cell Lymphoma', 'orgStudyIdInfo': {'id': 'SHR-A1912-I-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'SHR-A1912', 'interventionNames': ['Drug: SHR-A1912']}], 'interventions': [{'name': 'SHR-A1912', 'type': 'DRUG', 'description': 'SHR-A1912, dose escalation and expansion.', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Hengrui Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}