Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT07140393
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-24
First Post:
2025-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2025-08-17', 'studyFirstSubmitQcDate': '2025-08-18', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HRS4508 DLT', 'timeFrame': '3 weeks'}, {'measure': 'HRS4508 MTD', 'timeFrame': '12 weeks'}, {'measure': 'HRS4508 RP2D', 'timeFrame': '12 weeks'}, {'measure': 'The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)', 'timeFrame': '2 years'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Blood concentrations of HRS-4508', 'timeFrame': '15 weeks'}, {'measure': 'Blood concentrations of SHR-A1811', 'timeFrame': '9 weeks'}, {'measure': 'Blood concentrations of Capecitabine', 'timeFrame': '2 weeks'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': '1 year'}, {'measure': 'Best overall efficacy (BOR)', 'timeFrame': '1 year'}, {'measure': 'Duration of response (DoR)', 'timeFrame': '1 year'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': '1 year'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': '1 year'}, {'measure': 'Overall survival (OS)', 'timeFrame': '2 year'}, {'measure': 'The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)', 'timeFrame': '2 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumor']}, 'descriptionModule': {'briefSummary': 'The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 combination with other anti tumor therapy in subjects with solid tumor ; to evaluate HRS4508 DLT, MTD and RP2D, to evaluate the incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0), to evaluate ORR by researchers based on RECIST v1.1, to evaluate the pharmacokinetic (PK) characteristics of HRS-4508 SHR-1811, Capecitabine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 18 to 75 years old; Both men and women are welcome;\n2. The mixed cell types need to be confirmed by histology or cytology, and the dominant cell morphology, unresectable or metastatic .\n3. ECOG ratings of 0 or 1.\n4. Expected survival period ≥ 12 weeks.\n5. At least one measurable lesion outside the central nervous system that meets the RECIST v1.1 standard definition.\n6. Willing to participate and comply with the requirements of the research protocol, and willing to cooperate with follow-up visits.\n\nExclusion Criteria:\n\n1. Accompanied by untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis\n2. There have been significant severe infections and major surgeries in the past 4 weeks\n3. Existence of previous or concurrent malignant tumors\n4. Difficult to treat nausea, vomiting, or other gastrointestinal diseases that affect the use of oral medication\n5. Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration;'}, 'identificationModule': {'nctId': 'NCT07140393', 'briefTitle': 'A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'An Open, Multicenter Phase IB/II Clinical Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor', 'orgStudyIdInfo': {'id': 'HRS-4508-202-BC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HRS-4508+ Capecitabine', 'interventionNames': ['Drug: HRS-4508+ Capecitabine']}, {'type': 'EXPERIMENTAL', 'label': 'HRS-4508+ Trastuzumab', 'interventionNames': ['Drug: HRS-4508+ Trastuzumab']}, {'type': 'EXPERIMENTAL', 'label': 'HRS-4508+ Trastuzumab+ Pertuzumab', 'interventionNames': ['Drug: HRS-4508+ Trastuzumab+ Pertuzumab']}, {'type': 'EXPERIMENTAL', 'label': 'HRS-4508+ Trastuzumab+ Capecitabine', 'interventionNames': ['Drug: HRS-4508+ Trastuzumab+ Capecitabine']}, {'type': 'EXPERIMENTAL', 'label': 'Trastuzumab+ Capecitabine', 'interventionNames': ['Drug: Trastuzumab+ Capecitabine']}, {'type': 'EXPERIMENTAL', 'label': 'HRS-4508+A1811', 'interventionNames': ['Drug: HRS-4508+A1811']}], 'interventions': [{'name': 'HRS-4508+ Capecitabine', 'type': 'DRUG', 'description': 'HRS-4508+ Capecitabine', 'armGroupLabels': ['HRS-4508+ Capecitabine']}, {'name': 'HRS-4508+ Trastuzumab', 'type': 'DRUG', 'description': 'HRS-4508+ Trastuzumab', 'armGroupLabels': ['HRS-4508+ Trastuzumab']}, {'name': 'HRS-4508+ Trastuzumab+ Pertuzumab', 'type': 'DRUG', 'description': 'HRS-4508+ Trastuzumab+ Pertuzumab', 'armGroupLabels': ['HRS-4508+ Trastuzumab+ Pertuzumab']}, {'name': 'HRS-4508+ Trastuzumab+ Capecitabine', 'type': 'DRUG', 'description': 'HRS-4508+ Trastuzumab+ Capecitabine', 'armGroupLabels': ['HRS-4508+ Trastuzumab+ Capecitabine']}, {'name': 'Trastuzumab+ Capecitabine', 'type': 'DRUG', 'description': 'Trastuzumab+ Capecitabine', 'armGroupLabels': ['Trastuzumab+ Capecitabine']}, {'name': 'HRS-4508+A1811', 'type': 'DRUG', 'description': 'HRS-4508+A1811', 'armGroupLabels': ['HRS-4508+A1811']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Fei Ma', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Hospital Chinese Academy of Medical Science', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jiaman Lin', 'role': 'CONTACT', 'email': 'jiaman.lin@hengrui.com', 'phone': '+86 180 0245 4915'}, {'name': 'Yadan Huo', 'role': 'CONTACT', 'email': 'Yadan.huo.yh3@hengrui.com', 'phone': '+86 13381110273'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}