Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-02 @ 5:53 PM
Study NCT ID:
NCT06493760
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2 Study of SSGJ-707 in Metastatic Colorectal Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'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': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-04', 'studyFirstSubmitDate': '2024-06-25', 'studyFirstSubmitQcDate': '2024-07-09', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', '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 points'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SSGJ-707', 'colorectal cancer'], 'conditions': ['Metastatic Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This study includes two parts:Part 1: SSGJ-707 (different dosing regimens) in combination with chemotherapy for first-line treatment of metastatic colorectal cancer.Part 2: SSGJ-707 in combination with chemotherapy versus bevacizumab in combination with chemotherapy for first-line treatment of metastatic colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males and/or females over age 18\n2. Histologically and/or cytologically documented metastatic colorectal cancer confirmed .\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': 'NCT06493760', 'briefTitle': 'A Phase 2 Study of SSGJ-707 in Metastatic Colorectal 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 As First-Line Treatment in Metastatic Colorectal Cancer Patients', 'orgStudyIdInfo': {'id': 'SSGJ-707-CRC-II-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SSGJ-707(dose 1)+ XELOX', 'interventionNames': ['Drug: SSGJ-707', 'Drug: Oxaliplatin', 'Drug: Capecitabine']}, {'type': 'EXPERIMENTAL', 'label': 'SSGJ-707(dose 1)+ mFOLFOX6', 'interventionNames': ['Drug: SSGJ-707', 'Drug: Oxaliplatin', 'Drug: Calcium Folinate', 'Drug: 5-fluorouracil']}, {'type': 'EXPERIMENTAL', 'label': 'SSGJ-707(dose 2)+ XELOX', 'interventionNames': ['Drug: SSGJ-707', 'Drug: Oxaliplatin', 'Drug: Capecitabine']}, {'type': 'EXPERIMENTAL', 'label': 'SSGJ-707(dose 2)+ mFOLFOX6', 'interventionNames': ['Drug: SSGJ-707', 'Drug: Oxaliplatin', 'Drug: Calcium Folinate', 'Drug: 5-fluorouracil']}, {'type': 'EXPERIMENTAL', 'label': 'SSGJ-707+XELOX/mFOLFOX6', 'interventionNames': ['Drug: SSGJ-707', 'Drug: Oxaliplatin', 'Drug: Capecitabine', 'Drug: Calcium Folinate', 'Drug: 5-fluorouracil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bevacizumab+XELOX/mFOLFOX6', 'interventionNames': ['Drug: Bevacizumab', 'Drug: Oxaliplatin', 'Drug: Capecitabine', 'Drug: Calcium Folinate', 'Drug: 5-fluorouracil']}, {'type': 'EXPERIMENTAL', 'label': 'SSGJ-707 monotherapy', 'interventionNames': ['Drug: SSGJ-707']}], 'interventions': [{'name': 'SSGJ-707', 'type': 'DRUG', 'description': 'bispecific antibody', 'armGroupLabels': ['SSGJ-707 monotherapy', 'SSGJ-707(dose 1)+ XELOX', 'SSGJ-707(dose 1)+ mFOLFOX6', 'SSGJ-707(dose 2)+ XELOX', 'SSGJ-707(dose 2)+ mFOLFOX6', 'SSGJ-707+XELOX/mFOLFOX6']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'VEGF antibody', 'armGroupLabels': ['Bevacizumab+XELOX/mFOLFOX6']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'chemotherapy', 'armGroupLabels': ['Bevacizumab+XELOX/mFOLFOX6', 'SSGJ-707(dose 1)+ XELOX', 'SSGJ-707(dose 1)+ mFOLFOX6', 'SSGJ-707(dose 2)+ XELOX', 'SSGJ-707(dose 2)+ mFOLFOX6', 'SSGJ-707+XELOX/mFOLFOX6']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': 'chemotherapy', 'armGroupLabels': ['Bevacizumab+XELOX/mFOLFOX6', 'SSGJ-707(dose 1)+ XELOX', 'SSGJ-707(dose 2)+ XELOX', 'SSGJ-707+XELOX/mFOLFOX6']}, {'name': 'Calcium Folinate', 'type': 'DRUG', 'description': 'chemotherapy', 'armGroupLabels': ['Bevacizumab+XELOX/mFOLFOX6', 'SSGJ-707(dose 1)+ mFOLFOX6', 'SSGJ-707(dose 2)+ mFOLFOX6', 'SSGJ-707+XELOX/mFOLFOX6']}, {'name': '5-fluorouracil', 'type': 'DRUG', 'description': 'chemotherapy', 'armGroupLabels': ['Bevacizumab+XELOX/mFOLFOX6', 'SSGJ-707(dose 1)+ mFOLFOX6', 'SSGJ-707(dose 2)+ mFOLFOX6', 'SSGJ-707+XELOX/mFOLFOX6']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liu Tianshu, PhD', 'role': 'CONTACT', 'email': 'liu.tianshu@zs-hospital.sh.cn', 'phone': '13681973996'}, {'name': 'Liu Tianshu, PhD', 'role': 'CONTACT'}], 'facility': 'Liu Tianshu', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}