Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2025-12-31 @ 9:07 PM
Study NCT ID:
NCT06907628
Status:
RECRUITING
Last Update Posted:
2025-04-25
First Post:
2025-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of SHR-3792 Injection in 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2025-03-26', 'studyFirstSubmitQcDate': '2025-03-26', 'lastUpdatePostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD)', 'timeFrame': 'From the first dose of study medication up to 21 days.'}, {'measure': 'Recommended phase Ⅱ dose (RP2D)', 'timeFrame': 'From the first dose of study medication up to 21 days.'}, {'measure': 'Incidence of dose limited toxicity (DLT)', 'timeFrame': 'From the first dose of study medication up to 21 days.'}, {'measure': 'Adverse events (AEs)', 'timeFrame': 'Up to 24 weeks.'}, {'measure': 'Serious adverse events (SAEs)', 'timeFrame': 'Up to 24 weeks.'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'Up to 6 months.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-3792 injection monotherapy for patients with advanced solid tumors, and to explore the reasonable dosage of SHR-3792 injection monotherapy for patients with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects with ability to understand and voluntarily agree to participate by giving written informed consent form for the study.\n2. Patients with unresectable recurrent or metastatic solid tumors.\n3. There is at least one lesion that could be measured.\n4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.\n5. Adequate organ functions as defined.\n6. Life expectancy ≥ 3 months.\n\nExclusion Criteria:\n\n1. Patients with known active central nervous system (CNS) metastases.\n2. Subjects with other malignancy in five years before the first dose.\n3. Patients with tumor-related pain that cannot be controlled as determined.\n4. Patients with serious cardiovascular and cerebrovascular diseases.\n5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion.\n6. Patients with severe infections.\n7. History of immunodeficiency.\n8. History of autoimmune diseases.\n9. Active infection.\n10. Pregnant or nursing women.\n11. Known history of serious allergic reactions to the investigational product or its main ingredients.'}, 'identificationModule': {'nctId': 'NCT06907628', 'briefTitle': 'A Trial of SHR-3792 Injection in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.'}, 'officialTitle': 'A Phase Ⅰ, Open Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-3792 in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'SHR-3792-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-3792 Injection Group', 'interventionNames': ['Drug: SHR-3792 Injection']}], 'interventions': [{'name': 'SHR-3792 Injection', 'type': 'DRUG', 'description': 'SHR-3792 injection.', 'armGroupLabels': ['SHR-3792 Injection Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250117', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinming Yu', 'role': 'CONTACT', 'email': 'sdyujinming@126.com', 'phone': '+86-0531-67626073'}, {'name': 'Jinming Yu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shandong First Medical University Affiliated Cancer Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Fangfang Peng', 'role': 'CONTACT', 'email': 'fangfang.peng.fp5@hengrui.com', 'phone': '+86-0518-81220121'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}