Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-01-01 @ 3:58 AM
Study NCT ID:
NCT07038005
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-26
First Post:
2025-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of SPGL008 in Subjects With Advanced Malignant 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': 96}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-13', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-06-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2025-06-17', 'studyFirstSubmitQcDate': '2025-06-25', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Limiting Toxicity (DLT)', 'timeFrame': 'During the first cycle. Each cycle is 21 days', 'description': 'DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle(21 days) of treatment.'}, {'measure': 'Maximum tolerated dose (MTD)', 'timeFrame': 'During the first cycle. Each cycle is 21 days', 'description': 'MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to 2 years', 'description': 'Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria.'}, {'measure': 'Cmax', 'timeFrame': 'Up to 2 years'}, {'measure': 'Tmax', 'timeFrame': 'Up to 2 years'}, {'measure': 'T1/2', 'timeFrame': 'Up to 2 years'}, {'measure': 'AUC', 'timeFrame': 'Up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Malignant Tumors']}, 'descriptionModule': {'briefSummary': 'This study includes two cohorts, respectively evaluating safety, tolerability and preliminary efficacy of intravenous and subcutaneous administration of SPGL008.', 'detailedDescription': 'This study is a study of SPGL-008 monotherapy in patients with advanced malignant tumors. The study includes two cohorts, Cohort 1 and Cohort 2 will be administered by intravenous and subcutaneous administration respectively. Both cohorts will be conducted by the dose-escalation design to evaluate safety, tolerability and preliminary efficacy of different administration of SPGL008.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males and/or females, 18-75 years old;\n2. Histologically and/or cytologically documented advanced or metastatic malignant 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 SPGL008.'}, 'identificationModule': {'nctId': 'NCT07038005', 'briefTitle': 'A Phase I Study of SPGL008 in Subjects With Advanced Malignant Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shenyang Sunshine Pharmaceutical Co., LTD.'}, 'officialTitle': 'A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SPGL008 Monotherapy for Patients With Advanced Malignant Tumors', 'orgStudyIdInfo': {'id': 'SPGL008-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dose level 1 of SPGL008 （Intravenous administration）', 'interventionNames': ['Drug: SPGL008']}, {'type': 'EXPERIMENTAL', 'label': 'dose level 2 of SPGL008 （Intravenous administration）', 'interventionNames': ['Drug: SPGL008']}, {'type': 'EXPERIMENTAL', 'label': 'dose level 3 of SPGL008 （Intravenous administration）', 'interventionNames': ['Drug: SPGL008']}, {'type': 'EXPERIMENTAL', 'label': 'dose level 4 of SPGL008 （Intravenous administration）', 'interventionNames': ['Drug: SPGL008']}, {'type': 'EXPERIMENTAL', 'label': 'dose level 5 of SPGL008 （Intravenous administration）', 'interventionNames': ['Drug: SPGL008']}, {'type': 'EXPERIMENTAL', 'label': 'dose level 6 of SPGL008 （Intravenous administration）', 'interventionNames': ['Drug: SPGL008']}, {'type': 'EXPERIMENTAL', 'label': 'dose level 7 of SPGL008 （Intravenous administration）', 'interventionNames': ['Drug: SPGL008']}, {'type': 'EXPERIMENTAL', 'label': 'dose level 8 of SPGL008 （Intravenous administration）', 'interventionNames': ['Drug: SPGL008']}, {'type': 'EXPERIMENTAL', 'label': 'dose level 1 of SPGL008 （Subcutaneous administration）', 'interventionNames': ['Drug: SPGL008']}, {'type': 'EXPERIMENTAL', 'label': 'dose level 2 of SPGL008 （Subcutaneous administration）', 'interventionNames': ['Drug: SPGL008']}, {'type': 'EXPERIMENTAL', 'label': 'dose level 3 of SPGL008 （Subcutaneous administration）', 'interventionNames': ['Drug: SPGL008']}, {'type': 'EXPERIMENTAL', 'label': 'dose level 4 of SPGL008 （Subcutaneous administration）', 'interventionNames': ['Drug: SPGL008']}, {'type': 'EXPERIMENTAL', 'label': 'dose level 5 of SPGL008 （Subcutaneous administration）', 'interventionNames': ['Drug: SPGL008']}, {'type': 'EXPERIMENTAL', 'label': 'dose level 6 of SPGL008 （Subcutaneous administration）', 'interventionNames': ['Drug: SPGL008']}], 'interventions': [{'name': 'SPGL008', 'type': 'DRUG', 'description': 'Biological product', 'armGroupLabels': ['dose level 1 of SPGL008 （Intravenous administration）', 'dose level 1 of SPGL008 （Subcutaneous administration）', 'dose level 2 of SPGL008 （Intravenous administration）', 'dose level 2 of SPGL008 （Subcutaneous administration）', 'dose level 3 of SPGL008 （Intravenous administration）', 'dose level 3 of SPGL008 （Subcutaneous administration）', 'dose level 4 of SPGL008 （Intravenous administration）', 'dose level 4 of SPGL008 （Subcutaneous administration）', 'dose level 5 of SPGL008 （Intravenous administration）', 'dose level 5 of SPGL008 （Subcutaneous administration）', 'dose level 6 of SPGL008 （Intravenous administration）', 'dose level 6 of SPGL008 （Subcutaneous administration）', 'dose level 7 of SPGL008 （Intravenous administration）', 'dose level 8 of SPGL008 （Intravenous administration）']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'yongsheng Li', 'role': 'CONTACT', 'email': 'lys@cqu.edu.cn', 'phone': '17784310187'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenyang Sunshine Pharmaceutical Co., LTD.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Shenzhen Sciprogen Bio-pharmaceutical Co., Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}