Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-01-02 @ 10:07 AM
Study NCT ID:
NCT06840002
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent 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': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2025-02-17', 'studyFirstSubmitQcDate': '2025-02-17', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose limited toxicity (DLT)', 'timeFrame': 'Up to 21 days.'}, {'measure': 'Recommended phase II dose (RP2D)', 'timeFrame': 'Up to 21 days.'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'Every 9 weeks lasting about one year.'}], 'secondaryOutcomes': [{'measure': 'Duration of response (DoR)', 'timeFrame': 'Every 9 weeks lasting about one year.'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'Every 9 weeks lasting about one year.'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'Every 9 weeks lasting about one year.'}, {'measure': 'Standard response rate (RR)', 'timeFrame': 'Every 9 weeks lasting about one year.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Approximately 3 years after the last subject enrolled.'}, {'measure': 'Adverse events (AEs)', 'timeFrame': 'From the first drug administration to within 90 days after the last dose.'}, {'measure': 'Serious adverse events (SAEs)', 'timeFrame': 'From the first drug administration to within 90 days after the last dose.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'The objective is to evaluate the tolerance, safety, pharmacokinetic characteristics and immunogenicity of SHR-A1811 combined with carboplatin and bevacizumab in the treatment of platinum sensitive recurrent epithelial ovarian cancer, and to determine the RP2D of the combination, and preliminarily to evaluate the effectiveness of SHR-A1811 combined regimen in the treatment of platinum sensitive recurrent epithelial ovarian cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Voluntarily join this study, sign the informed consent form, have good compliance, and can cooperate with the follow-up.\n2. Sufficient fresh or archived tumor tissue specimens can be provided for testing by the third-party central laboratory designated by the sponsor.\n3. At least one measurable lesion conforming to RECIST v1.1.\n4. ECOG PS score: 0-1.\n5. Expected survival ≥ 12 weeks.\n6. Female subjects with fertility must agree to comply with the contraceptive requirements from signing the informed consent form to 7 months after the last administration of the trial drug.\n\nExclusion Criteria:\n\n1. With untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis.\n2. Pleural effusion, pericardial effusion or peritoneal effusion with clinical symptoms, which cannot be well controlled.\n3. Previous interstitial pneumonia or interstitial lung disease, non infectious pneumonia requiring steroid treatment.\n4. With hypertension and cannot be well controlled by antihypertensive drug treatment.\n5. Accompanied by poorly controlled or serious cardiovascular diseases.\n6. Subjects with serious infection within 1 month before the first medication.\n7. Have a history of immune deficiency, including HIV test positive, other acquired or congenital immune deficiency diseases, or a history of organ transplantation.\n8. There are any other factors that may affect the results of the study or cause the forced termination of the study, such as alcohol abuse, drug abuse, criminal detention, and other serious diseases (including mental illness) that need combined treatment.'}, 'identificationModule': {'nctId': 'NCT06840002', 'briefTitle': 'A Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.'}, 'officialTitle': 'An Open, Multicenter Phase Ib / II Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer', 'orgStudyIdInfo': {'id': 'SHR-A1811-216-OC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'interventionNames': ['Drug: SHR-A1811', 'Drug: Carboplatin', 'Drug: Bevacizumab', 'Drug: Oxaliplatin for Injection', 'Drug: Paclitaxel injection', 'Drug: Doxorubicin hydrochloride liposome injection', 'Drug: Adebrelimab Injection']}], 'interventions': [{'name': 'SHR-A1811', 'type': 'DRUG', 'description': 'SHR-A1811.', 'armGroupLabels': ['Treatment group']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Carboplatin.', 'armGroupLabels': ['Treatment group']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'Bevacizumab.', 'armGroupLabels': ['Treatment group']}, {'name': 'Oxaliplatin for Injection', 'type': 'DRUG', 'description': 'Oxaliplatin for injection.', 'armGroupLabels': ['Treatment group']}, {'name': 'Paclitaxel injection', 'type': 'DRUG', 'description': 'Paclitaxel injection.', 'armGroupLabels': ['Treatment group']}, {'name': 'Doxorubicin hydrochloride liposome injection', 'type': 'DRUG', 'description': 'Doxorubicin hydrochloride liposome injetction.', 'armGroupLabels': ['Treatment group']}, {'name': 'Adebrelimab Injection', 'type': 'DRUG', 'description': 'Adebrelimab injection.', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qinglei Gao', 'role': 'CONTACT', 'email': 'qingleigao@hotmail.com', 'phone': '13871127473'}, {'name': 'Qinglei Gao', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Shuni Wang', 'role': 'CONTACT', 'email': 'shuni.wang@hengrui.com', 'phone': '+86-0518-81220121'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}