Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-01-04 @ 4:55 PM
Study NCT ID:
NCT04446260
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2020-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 396}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2020-06-18', 'studyFirstSubmitQcDate': '2020-06-22', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse events (AEs)', 'timeFrame': 'From Day1 to 90 days after last dose', 'description': 'Frequency and seriousness of treatment emergent adverse events (TEAEs)'}], 'secondaryOutcomes': [{'measure': 'PK parameter: Tmax of SHR-A1811', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Time to maximal concentration (Tmax) of SHR-A1811'}, {'measure': 'PK parameter: Cmax of SHR-A1811', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Maximal concentration (Cmax) of SHR-A1811'}, {'measure': 'PK parameter: AUC0-t of SHR-A1811', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'AUC computed from time zero to the time of the last quantifiable concentration (AUC0-t) of SHR-A1811'}, {'measure': 'Immunogenicity of SHR-A1811', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Including anti-drug antibody and/or neutralizing antibody'}, {'measure': 'Tumor response using RECIST 1.1', 'timeFrame': 'From first dose to disease progression or death, whichever comes first, up to 30 months', 'description': 'RECIST=Response Evaluation Criteria in Solid Tumors Assessment of tumor response until disease progression or death to evaluate the efficacy of SHR-A1811 up to 30 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '38900984', 'type': 'DERIVED', 'citation': 'Yao H, Yan M, Tong Z, Wu X, Ryu MH, Park JJ, Kim JH, Zhong Y, Zhao Y, Voskoboynik M, Yin Y, Liu K, Kaubisch A, Liu C, Zhang J, Wang S, Im SA, Ganju V, Barve M, Li H, Ye C, Roy AC, Bai LY, Yen CJ, Gu S, Lin YC, Wu L, Bao L, Zhao K, Shen Y, Rong S, Zhu X, Song E. Safety, Efficacy, and Pharmacokinetics of SHR-A1811, a Human Epidermal Growth Factor Receptor 2-Directed Antibody-Drug Conjugate, in Human Epidermal Growth Factor Receptor 2-Expressing or Mutated Advanced Solid Tumors: A Global Phase I Trial. J Clin Oncol. 2024 Oct 10;42(29):3453-3465. doi: 10.1200/JCO.23.02044. Epub 2024 Jun 20.'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* LVEF ≥ 50% by either ECHO or MUGA\n* Has adequate renal and hepatic function\n* Female subjects agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment\n\nExclusion Criteria:\n\n* History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period\n* Known hereditary or acquired bleeding and thrombotic tendency'}, 'identificationModule': {'nctId': 'NCT04446260', 'briefTitle': 'A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Phase 1 Multi-Country, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1811 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects', 'orgStudyIdInfo': {'id': 'SHR-A1811-I-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 Dose escalation', 'interventionNames': ['Drug: SHR-A1811']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 PK expansion', 'interventionNames': ['Drug: SHR-A1811']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3 Indication expansion', 'interventionNames': ['Drug: SHR-A1811']}], 'interventions': [{'name': 'SHR-A1811', 'type': 'DRUG', 'description': 'be administered via intravenous (IV) infusion', 'armGroupLabels': ['Part 1 Dose escalation', 'Part 2 PK expansion', 'Part 3 Indication expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore-Einstein Center for Cancer Care', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Hospital System', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Mary Crowley Cancer Research', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '2109', 'city': 'Macquarie', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Macquarie University Hospital'}, {'zip': '5042', 'city': 'Bedford Park', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Southern Oncology Clinical Research Unit', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'zip': '3199', 'city': 'Frankston', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peninsula and South Eastern Haematology & Oncology Group', 'geoPoint': {'lat': -38.14458, 'lon': 145.12291}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Nucleus Network', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3004', 'city': 'Melbourne', 'country': 'Australia', 'facility': 'Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '233000', 'city': 'Bengbu', 'state': 'Anhui', 'country': 'China', 'facility': 'The first affiliated hospital of bengbu medical college', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}, {'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Cancer Hospital Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '350000', 'city': 'Fujian', 'state': 'Fuzhou', 'country': 'China', 'facility': 'Fujian Cancer Hospital', 'geoPoint': {'lat': 28.92651, 'lon': 106.12972}}, {'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Nanfang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-Sen Memorial Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Henan cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '430062', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Zhongnan hospital of Wuhan university', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430079', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Hubei cancer hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Xiangya hospital central south university', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '410031', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Hunan cancer hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Jiangsu Province Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Drum Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '110022', 'city': 'Shengyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Shengjing Hospital of China medical university'}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Fudan University Shanghai cancer center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Fudan Unversity Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Jiao Tong University School of Medicine Renji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '030000', 'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': 'Shanxi Cancer Hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '610042', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Sichuan Cancer Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '300181', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin medical university cancer institute&hoospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310014', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The second affiliated hospital Zhejiang university school of medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310014', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Zhejiang provincial people's hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '3080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '5505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '40447', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '70457', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital, Linkou', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Atridia Pty Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}