Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-01 @ 8:11 PM
Study NCT ID:
NCT05463432
Status:
COMPLETED
Last Update Posted:
2025-03-20
First Post:
2022-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of HR19024 in Subjects With Advanced Solid Tumor
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': 'HR19024 for all enrolled subjects'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2022-07-07', 'studyFirstSubmitQcDate': '2022-07-18', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD) of HR19024', 'timeFrame': '21-day cycle (tri-weekly)'}], 'secondaryOutcomes': [{'measure': 'Response rate (RR)', 'timeFrame': 'up to 6 months following the date the last patient was randomized'}, {'measure': 'Disease Control Rate', 'timeFrame': 'up to 6 months following the date the last patient was randomized'}, {'measure': 'Duration of Response', 'timeFrame': 'up to 6 months following the date the last patient was randomized'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'up to 6 months following the date the last patient was randomized'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumor']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety，tolerability，pharmacokinetic characteristics and preliminary efficacy of HR19024 injection in the treatment of advanced solid tumor'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ECOG performance status 0 or 1\n2. Histologically confirmed advanced solid tumor\n3. Life expectancy of greater than or equal to (\\>=) 12 weeks\n4. At least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (RECIST 1.1)\n5. Able and willing to provide a written informed consent\n\nExclusion Criteria:\n\n1. Subjects with unresolved toxicity （\\> CTCAE G1）of prior therapy at the time of enrolment\n2. Subjects who had received anti-tumor treatments such as surgery, chemotherapy, radiotherapy recently'}, 'identificationModule': {'nctId': 'NCT05463432', 'briefTitle': 'A Study of HR19024 in Subjects With Advanced Solid Tumor', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Hengrui Pharmaceutical Co., Ltd.'}, 'officialTitle': 'An Open-label Phase 1a Study of the Safety and Tolerability of HR19024 Injection in Subjects With Advanced Solid Tumor', 'orgStudyIdInfo': {'id': 'HR19024-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HR19024', 'description': 'Part 1: Dose escalation of HR19024 montherapy for advanced solid tumor Part 2：PK expansion of HR19024 montherapy for advanced solid tumor Part 3: Efficacy expansion of HR19024 montherapy for advanced solid tumor', 'interventionNames': ['Drug: HR19024']}], 'interventions': [{'name': 'HR19024', 'type': 'DRUG', 'description': 'Intravenous infusion', 'armGroupLabels': ['HR19024']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Hengrui Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}