Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT05394818
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2022-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Clinical Study of SHR-A2009 for 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', 'interventionModelDescription': 'Single Group Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-25', 'studyFirstSubmitDate': '2022-05-24', 'studyFirstSubmitQcDate': '2022-05-24', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD) or maximum administered dose (MAD)', 'timeFrame': 'From Day 1 to 90 days after last dose', 'description': 'Incidence and category of dose limiting toxicities (DLTs) during the first cycle of SHR-A2009 treatment.'}, {'measure': 'Recommended Phase 2 dose (RP2D)', 'timeFrame': 'From Day 1 to 90 days after last dose', 'description': 'RP2D will be determined on the basis of evaluation on MTD/MAD, PK, efficacy data in dose escalation and dose expansion stages.'}, {'measure': 'Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) ([CTCAE] v5.0)', 'timeFrame': 'From Day 1 to 90 days after last dose', 'description': 'Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0).'}], 'secondaryOutcomes': [{'measure': 'PK parameter: Tmax of SHR-A2009', 'timeFrame': 'approximately 6 months', 'description': 'Time to maximum concentration of SHR-A2009'}, {'measure': 'PK parameter: Cmax of SHR-A2009', 'timeFrame': 'approximately 6 months', 'description': 'Maximum concentration of SHR-A2009'}, {'measure': 'PK parameter: AUC0-t of SHR-A2009', 'timeFrame': 'approximately 6 months', 'description': 'area under the concentration-time curve from time 0 to the last measurable concentration time point of SHR-A2009'}, {'measure': 'PK parameter: AUC0-∞ of SHR-A2009', 'timeFrame': 'approximately 6 months', 'description': 'area under the concentration-time curve from time 0 to infinity of SHR-A2009'}, {'measure': 'Immunogenicity of SHR-A2009', 'timeFrame': 'approximately 9 months', 'description': 'Anti-SHR-A2009 antibody (ADA)'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': 'approximately within 36 months', 'description': 'Evaluated using RECIST 1.1'}, {'measure': 'Duration of response (DoR)', 'timeFrame': 'approximately within 36 months', 'description': 'Evaluated using RECIST 1.1'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'approximately within 36 months', 'description': 'Evaluated using RECIST 1.1'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'approximately within 36 months', 'description': 'Evaluated using RECIST 1.1'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumor']}, 'descriptionModule': {'briefSummary': 'This study is an open-label, phase I clinical trial of SHR-A2009 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;\n2. Have at least one measurable tumor lesion per RECIST v1.1;\n3. ECOG performance status of 0-1;\n4. Life expectancy ≥ 12 weeks;\n5. Adequate bone marrow and organ function.\n6. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Patients with active central nervous system metastases or meningeal metastases;\n2. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;\n3. Prior treatment with antibody-drug conjugate (ADC) consisting of topoisomerase I inhibitors;\n4. History of serious cardiovascular and cerebrovascular diseases;\n5. Severe infection within 4 weeks prior to the first dose;\n6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.'}, 'identificationModule': {'nctId': 'NCT05394818', 'briefTitle': 'The Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.'}, 'officialTitle': 'An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A2009 for Injection in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'SHR-A2009-I-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-A2009', 'interventionNames': ['Drug: SHR-A2009']}], 'interventions': [{'name': 'SHR-A2009', 'type': 'DRUG', 'description': 'The total dosage of SHR-A2009 was calculated according to the weight weighing results of the subjects before each administration, and was administered by intravenous drip.', 'armGroupLabels': ['SHR-A2009']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100039', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Chinese PLA General Hospital-Department of Medical Oncology', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}