Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-03-02 @ 6:13 AM
Study NCT ID:
NCT05740202
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-05
First Post:
2023-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of SHR-7367 in Subjects With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The study was divided into three phases, the dose escalation phase and the dose extension phase and therapeutic effect extension of SHR-7367 in subjects with advanced malignant tumors.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2023-01-28', 'studyFirstSubmitQcDate': '2023-02-13', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicities (DLTs)', 'timeFrame': 'Up to 3 weeks', 'description': 'Number of participants with DLTs'}, {'measure': 'Recommended phase II dose', 'timeFrame': 'first dose of study medication up to 21 days', 'description': 'The Recommended phase II dose of SHR-7367 injection'}, {'measure': 'Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)', 'timeFrame': 'Up to 12 months', 'description': '• Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0'}], 'secondaryOutcomes': [{'measure': 'Tumor response using RECIST 1.1', 'timeFrame': 'From first dose to disease progression or death, whichever comes first, up to 12 months'}, {'measure': 'peak time (Tmax)', 'timeFrame': 'Up to 12 months'}, {'measure': 'peak concentration (Cmax)', 'timeFrame': 'Up to 12 months'}, {'measure': 'area under curve from 0 to the last measurable concentration time point t (AUC0-t),', 'timeFrame': 'Up to 12 months'}, {'measure': 'area under curve from 0 to infinity (AUC0-∞)', 'timeFrame': 'Up to 12 months'}, {'measure': 'elimination half-life (t1/2)', 'timeFrame': 'Up to 12 months'}, {'measure': 'clearance rate (CL)', 'timeFrame': 'Up to 12 months'}, {'measure': 'steady-state apparent volume of distribution (Vss)', 'timeFrame': 'Up to 12 months'}, {'measure': 'steady-state peak concentration (Cmax, ss)', 'timeFrame': 'Up to 12 months'}, {'measure': 'steady-state valley concentration (Ctrough, ss)', 'timeFrame': 'Up to 12 months'}, {'measure': 'accumulation ratio (Rac)', 'timeFrame': 'Up to 12 months'}, {'measure': 'percentage of activated B lymphocyte subsets in peripheral blood', 'timeFrame': 'Up to 12 months'}, {'measure': 'Immunogenicity index: drug-resistant antibody (ADA)', 'timeFrame': 'Up to 12 months'}, {'measure': 'Efficacy endpoints: Objective response rate (ORR)', 'timeFrame': 'Up to 12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-7367 in subjects with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;\n2. Male or female aged ≥18 years and ≤75 years at the time of signing the ICF;\n3. Histopathologically or cytologically documented advanced or metastatic malignancies;\n4. At least 1 measurable lesion conforming to RECIST 1.1 criteria;\n5. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;\n6. Female and male patients of reproductive potential must agree to use highly effective contraception.\n\nExclusion Criteria:\n\n1. Any immunostimulants administered within 4 weeks;\n2. Systemic anti-tumor therapy within 4 weeks;\n3. Any investigational cancer therapy administered within 4 weeks;\n4. Surgical procedures requiring general anesthesia within 4 weeks;\n5. History of autoimmune diseases;\n6. History of immunodeficiency;\n7. Severe infections within 2 weeks prior to the first study treatment;\n8. Clinically significant cardiovascular condition;\n9. Prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment;\n10. Known history of serious allergic reactions to the investigational product or its main ingredients.'}, 'identificationModule': {'nctId': 'NCT05740202', 'briefTitle': 'A Trial of SHR-7367 in Subjects With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Hengrui Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of SHR-7367 in Subjects With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'SHR-7367-I-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-7367', 'interventionNames': ['Drug: SHR-7367']}], 'interventions': [{'name': 'SHR-7367', 'type': 'DRUG', 'description': 'The study was divided into three phases, the dose escalation phase and the dose extension phase and therapeutic effect extension of SHR-7367 in subjects with advanced malignant tumors.', 'armGroupLabels': ['SHR-7367']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Medical University Cancer Institute and Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Hengrui Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}