Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2026-01-14 @ 2:45 AM
Study NCT ID:
NCT06522828
Status:
RECRUITING
Last Update Posted:
2024-10-21
First Post:
2024-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate SSGJ-707 in Advanced Gynecologic Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine 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': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-17', 'studyFirstSubmitDate': '2024-07-22', 'studyFirstSubmitQcDate': '2024-07-22', 'lastUpdatePostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR', 'timeFrame': '12 months', 'description': 'Objective response rate'}, {'measure': 'Safety and tolerability', 'timeFrame': '12 months', 'description': 'Safety and tolerability assessed by incidence and severity of adverse events'}], 'secondaryOutcomes': [{'measure': 'PFS', 'timeFrame': '24 months', 'description': 'The efficacy end point'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced/recurrent Endometrial Cancer and Platinum-resistant Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'This is an open, multicenter Phase II clinical study of SSGJ-707 combined with chemotherapy in the treatment of advanced/recurrent endometrial cancer and platinum-resistant ovarian cancer. The objective is to evaluate the safety, tolerability and antitumor activity of SSGJ-707 in the treatment of advanced/recurrent endometrial cancer and platinum-resistant ovarian cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age:18-75 years old\n2. Advanced endometrial cancer and platinum-resistant ovarian cancer\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Expected survival \\>=12 weeks.\n5. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Known uncontrolled or symptomatic central nervous system metastatic disease.\n2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \\>1 (National Cancer Institute Common terminology Criteria \\[NCI CTCAE\\] v.5.0).\n3. Inadequate organ or bone marrow function.\n4. Pregnant or breast-feeding woman.\n5. Known allergies, hypersensitivity, or intolerance to SSGJ-707 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT06522828', 'briefTitle': 'A Study to Evaluate SSGJ-707 in Advanced Gynecologic Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.'}, 'officialTitle': 'A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 in Advanced Gynecologic Cancer Patients', 'orgStudyIdInfo': {'id': 'SSGJ-707-ST-II-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SSGJ-707(dose 1)+ carboplatin + paclitaxel', 'interventionNames': ['Drug: SSGJ-707', 'Drug: carboplatin', 'Drug: paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'SSGJ-707(dose 2)+ carboplatin + paclitaxel', 'interventionNames': ['Drug: SSGJ-707', 'Drug: carboplatin', 'Drug: paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'SSGJ-707(dose 3)+ carboplatin + paclitaxel', 'interventionNames': ['Drug: SSGJ-707', 'Drug: carboplatin', 'Drug: paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'SSGJ-707(dose 4)+ paclitaxel', 'interventionNames': ['Drug: SSGJ-707', 'Drug: paclitaxel']}], 'interventions': [{'name': 'SSGJ-707', 'type': 'DRUG', 'description': 'SSGJ-707 is a bispecific antibody against human PD-1 and VEGF', 'armGroupLabels': ['SSGJ-707(dose 1)+ carboplatin + paclitaxel', 'SSGJ-707(dose 2)+ carboplatin + paclitaxel', 'SSGJ-707(dose 3)+ carboplatin + paclitaxel', 'SSGJ-707(dose 4)+ paclitaxel']}, {'name': 'carboplatin', 'type': 'DRUG', 'description': 'chemotherapy', 'armGroupLabels': ['SSGJ-707(dose 1)+ carboplatin + paclitaxel', 'SSGJ-707(dose 2)+ carboplatin + paclitaxel', 'SSGJ-707(dose 3)+ carboplatin + paclitaxel']}, {'name': 'paclitaxel', 'type': 'DRUG', 'description': 'chemotherapy', 'armGroupLabels': ['SSGJ-707(dose 1)+ carboplatin + paclitaxel', 'SSGJ-707(dose 2)+ carboplatin + paclitaxel', 'SSGJ-707(dose 3)+ carboplatin + paclitaxel', 'SSGJ-707(dose 4)+ paclitaxel']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'ZHOU QI, PhD', 'role': 'CONTACT', 'email': 'qizhou9128@163.com', 'phone': '+86 13708384529'}], 'facility': 'Chongqing Cancer Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'ZHOU, PhD', 'role': 'CONTACT', 'email': 'qizhou9128@163.com', 'phone': '13708384529'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}