Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-31 @ 6:26 PM
Study NCT ID:
NCT05162469
Status:
COMPLETED
Last Update Posted:
2025-07-28
First Post:
2021-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of SHR-A1909 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Dose escalation (non randomized， 6 arms); Dose-expansion and efficacy-expansion(non-randomized,1-3 arms)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2021-12-05', 'studyFirstSubmitQcDate': '2021-12-05', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MTD of SHR-1909', 'timeFrame': 'From Day 1 to 4 weeks', 'description': 'Maximum tolerated dose (MTD) based on dose-limiting toxicities (DLTs)'}, {'measure': 'RP2D of SHR-1909', 'timeFrame': 'From Day 1 to 90 days after last dose', 'description': 'Recommended Phase 2 Dose(RP2D) of SHR-1909 will be determined during the dose-escalation and dose-expansion parts of the study. RP2D will be determined using available safety, pharmacokinetics and pharmacodynamics data.'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '90 days after the last dose', 'description': 'Adverse Events documented by CTCAE 5.0'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to approximately 2 years', 'description': 'Baseline to documented disease progression or study discontinuation'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Up to approximately 2 years', 'description': 'From Day 1 to Radiographic Progression or Death Due to Any Cause'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Malignant Cancer']}, 'descriptionModule': {'briefSummary': 'This is an, open-label, multi-center, three-part phase I trial to evaluate the safety, pharmacokinetics and immunogenicity of SHR-1909 and preliminary anti-tumor efficacy of SHR-1909 in advanced malignant cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n* Patients must have cytologically or histologically confirmed advanced malignant tumor, and must have failed standard treatment;\n* Toxicities caused by prior anti-tumor treatments must have resolved to CTCAE Grade ≤ 1 prior to the first dose (except for alopecia or hypothyroidism treated with hormone replacement therapy or diabetes controlled with insulin);\n* Adequate organ function.\n\nExclusion Criteria:\n\n* With CNS infiltration, or ascites requiring paracentesis or symptomatic pleural effusion;\n* Received prior CAR T-cell therapy;\n* Received allogeneic hematopoietic stem cell transplantation within 3 months prior to the start of study treatment, or with acute/chronic graft versus host disease;\n* With active infection or fever of unknown origin (\\> 38.5 °C).'}, 'identificationModule': {'nctId': 'NCT05162469', 'briefTitle': 'A Study of SHR-A1909 in Subjects With Advanced Malignant Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Hengrui Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-1909 Injection in Patients With Advanced Malignant Tumors', 'orgStudyIdInfo': {'id': 'SHR-1909-I-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-1909 monotherapy', 'interventionNames': ['Drug: SHR-1909 injection']}], 'interventions': [{'name': 'SHR-1909 injection', 'type': 'DRUG', 'description': 'SHR-1909 for intravenous injection;Strength:6ml:0.3g/vial. Dose escalation (non randomized, 6 dose-levels); Dose-expansion and efficacy-expansion(non-randomized,1-3 dose-level(s)).', 'armGroupLabels': ['SHR-1909 monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130000', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'Jilin Cancer Hospital', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Hengrui Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}