Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-11 @ 3:04 AM
Study NCT ID:
NCT06533605
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-01
First Post:
2024-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Clinical Study to Evaluate the Safety and Efficacy of SSGJ-706 Monotherapy for Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2024-07-29', 'studyFirstSubmitQcDate': '2024-07-29', 'lastUpdatePostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DLTs', 'timeFrame': '12 months', 'description': 'Dose limiting toxicity'}, {'measure': 'MTD or MAD', 'timeFrame': '12 months', 'description': 'maximum tolerated dose or the maximum administered dose if MTD is not reached'}], 'secondaryOutcomes': [{'measure': 'The blood concentration of SSGJ-706', 'timeFrame': '12 months', 'description': 'PK characteristics'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Solid Tumors'], 'conditions': ['Advanced Solid Tumors Patients']}, 'descriptionModule': {'briefSummary': 'This study includes two parts, different part has different administration frequencies of SSGJ-706.', 'detailedDescription': 'This study is a study of SSGJ-706 monotherapy in advanced Solid Tumors. This study includes two parts, different part has different administration frequencies of SSGJ-706. Part A is QW and part B is Q3W. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-706 in advanced Solid Tumors.'}, '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 advanced or metastatic Solid Tumors .\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Expected survival \\>=3 months.\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-706 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT06533605', 'briefTitle': 'Phase I Clinical Study to Evaluate the Safety and Efficacy of SSGJ-706 Monotherapy for Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.'}, 'officialTitle': 'Phase I Clinical Study to Evaluate the Safety, Tolerability, and Initial Efficacy of SSGJ-706 Monotherapy for Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'SSGJ-706-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'dose level 1 of SSGJ-706', 'interventionNames': ['Drug: SSGJ-706']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'dose level 2 of SSGJ-706', 'interventionNames': ['Drug: SSGJ-706']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': 'dose level 3 of SSGJ-706', 'interventionNames': ['Drug: SSGJ-706']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4', 'description': 'dose level 4 of SSGJ-706', 'interventionNames': ['Drug: SSGJ-706']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 5', 'description': 'dose level 5 of SSGJ-706', 'interventionNames': ['Drug: SSGJ-706']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 6', 'description': 'dose level 6 of SSGJ-706', 'interventionNames': ['Drug: SSGJ-706']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 7', 'description': 'dose level 1 of SSGJ-706', 'interventionNames': ['Drug: SSGJ-706']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 8', 'description': 'dose level 2 of SSGJ-706', 'interventionNames': ['Drug: SSGJ-706']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 9', 'description': 'dose level 3 of SSGJ-706', 'interventionNames': ['Drug: SSGJ-706']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 10', 'description': 'dose level 4 of SSGJ-706', 'interventionNames': ['Drug: SSGJ-706']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 11', 'description': 'dose level 5 of SSGJ-706', 'interventionNames': ['Drug: SSGJ-706']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 12', 'description': 'dose level 6 of SSGJ-706', 'interventionNames': ['Drug: SSGJ-706']}], 'interventions': [{'name': 'SSGJ-706', 'type': 'DRUG', 'description': 'Bispecific antibody', 'armGroupLabels': ['Arm 1', 'Arm 10', 'Arm 11', 'Arm 12', 'Arm 2', 'Arm 3', 'Arm 4', 'Arm 5', 'Arm 6', 'Arm 7', 'Arm 8', 'Arm 9']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hao Chen, MD, Ph.D', 'role': 'CONTACT', 'email': 'chenhao3996913@163.com', 'phone': '15009467790'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}