Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05896020
Status:
RECRUITING
Last Update Posted:
2023-08-22
First Post:
2023-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of SHR-A1811 in Subjects With Gynaecologic Oncology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm study of SHR-A1811'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 225}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-21', 'studyFirstSubmitDate': '2023-05-28', 'studyFirstSubmitQcDate': '2023-06-08', 'lastUpdatePostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': '12 months'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': '12 months'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': '12 months'}, {'measure': 'Duration of response (DOR)', 'timeFrame': '12 months'}, {'measure': 'Overall survival (OS)', 'timeFrame': '12 months'}, {'measure': 'Incidence and severity of adverse events (AEs)', 'timeFrame': 'From Day 1 to 90 days after last dose'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gynaecological Malignancies']}, 'descriptionModule': {'briefSummary': 'This is an open-label, two-part study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with a gynaecological malignancies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The subjects voluntarily joined the study and signed the ICF.\n2. Measurable disease, as defined by RECIST v1.1.\n3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.\n4. Life expectancy ≥ 12 weeks.\n5. Subjects with advanced cervical cancer, recurrent ovarian cancer and endometrial cancer.\n\nExclusion Criteria:\n\n1. Symptomatic, untreated or active central nervous system metastases.\n2. Previously received antibo-conjugated drugs with the following characteristics: topoisomerase I inhibition in the composition Preparations, such as Enhertu (DS-8201a), U3-1402, etc..\n3. Have uncontrolled or severe cardiovascular disease.\n4. With any active autoimmune disease or history of autoimmune disease.\n5. Patients with active hepatitis B or hepatitis C.\n6. Severe infections within 28 days prior to initiation of study treatment.\n7. Active tuberculosis within one year prior to initiation of study treatment.'}, 'identificationModule': {'nctId': 'NCT05896020', 'briefTitle': 'A Study of SHR-A1811 in Subjects With Gynaecologic Oncology', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'Open, Multicenter Phase II Clinical Study of SHR-A1811 for Injection in the Treatment of Gynaecological Malignancies', 'orgStudyIdInfo': {'id': 'SHR-A1811-209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group with SHR-A1811', 'interventionNames': ['Drug: SHR- A1811']}], 'interventions': [{'name': 'SHR- A1811', 'type': 'DRUG', 'description': 'Subjects with gynaecological malignancies', 'armGroupLabels': ['Treatment group with SHR-A1811']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Beihua Kong, Doctor', 'role': 'CONTACT', 'email': 'kongbeihua@sdu.edu.cn', 'phone': '+86-18653199168'}], 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Bo Li, Ph.D.', 'role': 'CONTACT', 'email': 'bo.li@hengrui.com', 'phone': '+86 021-61053363'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}