Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-31 @ 11:31 PM
Study NCT ID:
NCT04818333
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2021-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of SHR-A1811 in Subjects With Advanced Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm study of SHR-A1811'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 157}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-11', 'studyFirstSubmitDate': '2021-03-25', 'studyFirstSubmitQcDate': '2021-03-25', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1:Incidence of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811', 'timeFrame': 'From Day 1 to90 days after last dose ，appropriately to 3 years', 'description': 'Assess safety and tolerability of SHR-A1811 by way of adverse events (CTCAE v5.0)'}, {'measure': 'Phase 1:Severity of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811', 'timeFrame': 'From Day 1 to90 days after last dose ，appropriately to 3 years', 'description': 'Assess safety and tolerability of SHR-A1811 by way of adverse events (CTCAE v5.0)'}, {'measure': 'Phase1: Maximum tolerated dose (MTD)', 'timeFrame': '12 months', 'description': 'Incidence rate and category of dose limiting toxicities (DLTs) during the first 21-day cycle of SHR-A1811 treatment'}, {'measure': 'Phase 1: Recommended Phase 2 dose (RP2D)', 'timeFrame': '12 months', 'description': 'RP2D was determined based on the safety, tolerability, PK, immunogenicity data and efficacy information obtained'}, {'measure': 'Phase2:ObjectiveResponse Rate (ORR)', 'timeFrame': 'Subjects were evaluated on tumor imaging every 6 weeks after treatment initiation and every 12 weeks after 54 weeks, until imaging progression, initiation of new antitumor therapy, loss of follow-up, and death，appropriately to 3 years', 'description': 'As assessed by RECIST v1.1 , as assessed by independent review committee (IRC)'}], 'secondaryOutcomes': [{'measure': 'Phase 1：PK parameter ：Tmax of SHRA1811', 'timeFrame': 'appropriately to 3 years', 'description': 'Time to maximal concentration (Tmax) of SHR-A1811'}, {'measure': 'Phase1:PK parameter: Cmax of SHR-A1811', 'timeFrame': 'appropriately to 3 years', 'description': 'Maximal concentration (Cmax) of SHR-A1811'}, {'measure': 'Phase1:PK parameter: AUC0-t of SHR-A1811', 'timeFrame': 'appropriately to 3 years', 'description': 'AUC computed from time zero to the time of the last quantifiable concentration (AUC0-t) of SHR-A1811'}, {'measure': 'Phase1:Immunogenicity of SHR-A1811', 'timeFrame': 'Immunogenicity sample collection time points include: within 30 min before administration of C1D1, C2D1, C3D1, C4D1, C6D1 and C8D1 starting from cycle 11 only in every 3 cycles ,appropriately to 3 years', 'description': 'Including anti-drug antibody and/or neutralizing antibody'}, {'measure': 'Phase2:Progression Free Survival (PFS)', 'timeFrame': 'appropriately to 3 years', 'description': 'As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator'}, {'measure': 'Phase2:ObjectiveResponse Rate (ORR)', 'timeFrame': 'appropriately to 3 years', 'description': 'As assessed by RECIST v1.1 , as assessed by investigator'}, {'measure': 'Phase2:Duration of response (DOR)', 'timeFrame': 'appropriately to 3 years', 'description': 'As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator'}, {'measure': 'Phase2:Disease control rate (DCR)', 'timeFrame': 'appropriately to 3 years', 'description': 'As assessed by RECIST v1.1 , as assessed by independent review committee (IRC) and investigator'}, {'measure': 'Phase2:Overall survival (OS)', 'timeFrame': 'Approximately 5 years after last subject enrolled'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Non-small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '40020696', 'type': 'DERIVED', 'citation': 'Li Z, Wang Y, Sun Y, Wang L, Li X, Sun L, He Z, Yang H, Wang Y, Wang Q, Song Z, Hong W, Wang Y, Xia G, Yu Y, Peng M, Song Y, Wang D, Meng R, Fang J, Luo Y, Liang W, Hu S, Wang Z, Song K, Li Y, Yang L, Shi W, Lu S. Trastuzumab rezetecan, a HER2-directed antibody-drug conjugate, in patients with advanced HER2-mutant non-small-cell lung cancer (HORIZON-Lung): phase 2 results from a multicentre, single-arm study. Lancet Oncol. 2025 Apr;26(4):437-446. doi: 10.1016/S1470-2045(25)00012-9. Epub 2025 Feb 25.'}, {'pmid': '39004647', 'type': 'DERIVED', 'citation': 'Li Z, Song Z, Hong W, Yang N, Wang Y, Jian H, Liang Z, Hu S, Peng M, Yu Y, Wang Y, Jiao Z, Zhao K, Song K, Li Y, Shi W, Lu S. SHR-A1811 (antibody-drug conjugate) in advanced HER2-mutant non-small cell lung cancer: a multicenter, open-label, phase 1/2 study. Signal Transduct Target Ther. 2024 Jul 15;9(1):182. doi: 10.1038/s41392-024-01897-y.'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1811 for injection in subjects with advanced non-small cell lung cancer who have HER2 expression , amplification, or mutation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able and willing to provide a written informed consent\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n3. advanced non-small cell lung cancer with HER2 expression , amplification, or mutation\n4. has previously received platinum-based chemotherapy for advanced or metastatic NSCLC, has developed disease progression during or after treatment, or is unable to tolerate platinum-based chemotherapy.\n5. There is at least one measurable lesion according to RECIST V1.1 criteria\n\nExclusion Criteria:\n\n1. Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.\n2. Has received HER2 antibody drug conjugates,\n3. Central nervous system metastasis or meningeal metastasis with clinical symptoms\n4. Has active infection requiring systemic treatment.'}, 'identificationModule': {'nctId': 'NCT04818333', 'briefTitle': 'A Study of SHR-A1811 in Subjects With Advanced Non-small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'Phase I/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1811 for Injection in Subjects With Advanced Non-small Cell Lung Cancer Who Have HER2 Expression , Amplification, or Mutation', 'orgStudyIdInfo': {'id': 'SHR-A1811-I-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-A1811', 'description': 'SHR-A1811 was administered intravenously every 3 weeks (Q3W) until discontinuation treatment', 'interventionNames': ['Drug: SHR-A1811']}], 'interventions': [{'name': 'SHR-A1811', 'type': 'DRUG', 'description': 'Phase 1 Drug: SHR-A1811 There are four pre-defined dose regimens . Subjects will be enrolled with an initial dose Phase 2 Drug: SHR-A1811 Doses will be determined from Phase 1', 'armGroupLabels': ['SHR-A1811']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}