Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT07022002
Status:
RECRUITING
Last Update Posted:
2025-08-03
First Post:
2025-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SSGJ-705 Monotherapy and Combination Therapy in Advanced HER2-Expressing Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 340}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2025-06-06', 'studyFirstSubmitQcDate': '2025-06-06', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': '12 months', 'description': 'The primary efficacy end point'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': '12 months', 'description': 'The primary safety end point'}, {'measure': 'Severity of Treatment-Emergent Adverse Events', 'timeFrame': '12 months', 'description': 'The primary safety end point'}], 'secondaryOutcomes': [{'measure': 'Progression-Free-Survival (PFS)', 'timeFrame': '24 months', 'description': 'The secondary efficacy end point'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['advanced malignancies'], 'conditions': ['Locally Advanced, Recurrent or Metastatic Malignancies']}, 'descriptionModule': {'briefSummary': 'This study was an open-label phase Ⅱ study to evaluate the safety and efficacy of SSGJ-705 Monotherapy and Combination Therapy in patients with advanced HER2-Expressing Solid Tumors.', 'detailedDescription': 'This study includes 2 Parts: Part 1 (705 monotherapy for advanced gastric cancer and breast cancer that have failed standard treatment), and Part 2 (705 in combination with chemotherapy for previously untreated advanced gastric cancer and lung cancer).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and/or females over age 18.\n* Histologically and/or cytologically documented local advanced or metastatic non-Small Cell Lung Cancer（NSCLC），Breast Cancer（BC）or Gastric/Gastroesophageal Junction Cancer （G/GEJC).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Expected survival \\>3 months.\n* Signed informed consent form.\n\nExclusion Criteria:\n\n* Any remaining adverse events (AEs) \\> grade 1 from prior anti-tumor treatment as per Common Terminology Criteria for Adverse Events（CTCAE） v5. 0, with exception of hair loss, fatigue, and grade 2 peripheral neurotoxicity.\n* Pregnant or nursing women or women/men who are ready to give birth.\n* symptomatic central nervous system metastasis.\n* Allergy to other antibody drugs or any excipients in the study drugs.\n* Inadequate organ or bone marrow function.'}, 'identificationModule': {'nctId': 'NCT07022002', 'briefTitle': 'SSGJ-705 Monotherapy and Combination Therapy in Advanced HER2-Expressing Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shenyang Sunshine Pharmaceutical Co., LTD.'}, 'officialTitle': 'A Phase II Study to Evaluate the Safety and Efficacy of SSGJ-705 Monotherapy and Combination Therapy in Patients With Advanced HER2-Expressing Solid Tumors', 'orgStudyIdInfo': {'id': 'SSGJ-705-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1', 'description': 'advanced gastric cancer and breast cancer that have failed standard treatment', 'interventionNames': ['Drug: SSGJ-705']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2', 'description': 'previously untreated advanced gastric cancer and lung cancer', 'interventionNames': ['Drug: PD-1/L1 inhibitor combined with chemotherapy', 'Drug: SSGJ-705 combined with chemotherapy']}], 'interventions': [{'name': 'SSGJ-705', 'type': 'DRUG', 'description': 'anti-PD-1 (programmed cell death protein 1) and anti-HER2 (Human Epidermal GrowthFactor Receptor 2)bispecifc antibody', 'armGroupLabels': ['Part 1']}, {'name': 'PD-1/L1 inhibitor combined with chemotherapy', 'type': 'DRUG', 'description': 'Immune checkpoint inhibitors', 'armGroupLabels': ['Part 2']}, {'name': 'SSGJ-705 combined with chemotherapy', 'type': 'DRUG', 'description': 'anti-PD-1 and anti-HER2 bispecifc antibody', 'armGroupLabels': ['Part 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feiyan Li', 'role': 'CONTACT', 'email': 'lify1697@zjcc.org.cn', 'phone': '0571-88122482'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Jieer Ying, M.D', 'role': 'CONTACT', 'email': 'hzyingjieer@163.com', 'phone': '86-13858195803'}, {'name': 'Meifang Zheng, M.D.', 'role': 'CONTACT', 'email': '794998553@qq.com', 'phone': '86-15258894828'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenyang Sunshine Pharmaceutical Co., LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}