Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-26 @ 6:47 PM
Study NCT ID:
NCT06394492
Status:
RECRUITING
Last Update Posted:
2024-08-09
First Post:
2024-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D019772', 'term': 'Topotecan'}], 'ancestors': [{'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'To evaluate the efficacy and safety of SHR-A1921 compared with investigator-chosen chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 440}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2024-04-27', 'studyFirstSubmitQcDate': '2024-04-27', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS) assessed by Blinded Independ Review Committee (BIRC) as per RECIST 1.1', 'timeFrame': 'Screening up to study completion, an average of 1 year'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Screening up to study completion, an average of 1 year'}, {'measure': 'Objective Response Rate (ORR), assessed by site investigator as per RECIST 1.1', 'timeFrame': 'Screening up to study completion, an average of 1 year'}, {'measure': 'Duration of Response (DoR), assessed by site investigator as per RECIST 1.1', 'timeFrame': 'Screening up to study completion, an average of 1 year'}, {'measure': 'Disease Control Rate (DCR), assessed by site investigator as per RECIST 1.1', 'timeFrame': 'Screening up to study completion, an average of 1 year'}, {'measure': 'Response Rate (RR) assessed by RECIST 1.1 and Gynaecologic Cancer Intergroup (GCIG) criteria', 'timeFrame': 'Screening up to study completion, an average of 1 year'}, {'measure': 'CA-125 Response Rate assessed by the Gynaecologic Cancer Intergroup (GCIG) criteria', 'timeFrame': 'Screening up to study completion, an average of 1 year'}, {'measure': 'Adverse Events', 'timeFrame': 'Screening up to study completion, an average of 1 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': "This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of SHR-A1921 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Voluntary participation and written informed consent.\n2. 18 years and older, female.\n3. Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.\n4. Patients must have platinum-resistant disease\n5. Be able to provide fresh or archived tumour tissue.\n6. At least one measurable lesion according to RECIST v1.1.\n7. Eastern Cooperative Oncology Group (ECOG) score: 0-1.\n8. With a life expectancy ≥ 12 weeks.\n9. Adequate bone marrow reserve and organ function.\n10. Contraception is required during the trial.\n\nExclusion Criteria:\n\n1. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.\n2. Previous or co-existing malignancies.\n3. Current or History of ILD.\n4. Clinical symptoms or diseases of the heart that are not well controlled.\n5. Arterial/venous thrombosis events occurred before the first dose.\n6. Grade ≥2 bleeding events of CTCAE occurred before the first dose.\n7. Gastrointestinal perforation or fistula, urethral fistula, abdominal abscess occurred before the first dose.\n8. Patients with intestinal obstruction or parenteral nutrition before the first dose.\n9. Serious infection before the first dose.\n10. Active hepatitis B or active hepatitis C.\n11. Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.\n12. Treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload.\n13. Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.\n14. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921.\n15. Other inappropriate situation considered by the investigator.'}, 'identificationModule': {'nctId': 'NCT06394492', 'briefTitle': 'SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.'}, 'officialTitle': "A Randomized, Open-Label, Controlled, Phase III Study of SHR-A1921 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer", 'orgStudyIdInfo': {'id': 'SHR-A1921-303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group 1: SHR-A1921', 'interventionNames': ['Drug: SHR-A1921']}, {'type': 'ACTIVE_COMPARATOR', 'label': "Treatment group 2: Investigator's choice of chemotherapy", 'interventionNames': ['Drug: Doxorubicin', 'Drug: Paclitaxel', 'Drug: Topotecan']}], 'interventions': [{'name': 'SHR-A1921', 'type': 'DRUG', 'description': 'SHR-A1921 dose 1', 'armGroupLabels': ['Treatment group 1: SHR-A1921']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'description': 'Doxorubicin dose 2', 'armGroupLabels': ["Treatment group 2: Investigator's choice of chemotherapy"]}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Paclitaxel dose 3', 'armGroupLabels': ["Treatment group 2: Investigator's choice of chemotherapy"]}, {'name': 'Topotecan', 'type': 'DRUG', 'description': 'Topotecan dose 4', 'armGroupLabels': ["Treatment group 2: Investigator's choice of chemotherapy"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lingyin Wu, Doctor', 'role': 'CONTACT'}], 'facility': 'National Cancer Center/Tumor Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tao Zhu, Doctor', 'role': 'CONTACT'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Shuni Wang', 'role': 'CONTACT', 'email': 'shuni.wang@hengrui.com', 'phone': '+86 021-61053363'}, {'name': 'Di Zong', 'role': 'CONTACT', 'email': 'di.zong@hengrui.com', 'phone': '+86 021-61053363'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}