protocolSection identificationModule nctId: NCT06271837, orgStudyIdInfo id: D781AC00001, briefTitle: A Study of T-DXd in Patients With Selected HER2-overexpressing Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-18, primaryCompletionDateStruct date: 2025-10-30, completionDateStruct date: 2026-04-17, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, collaborators name: Daiichi Sankyo Co., Ltd., descriptionModule briefSummary: This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of trastuzumab deruxtecan for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2 overexpressingsolid tumors which are not eligible for curative therapy., conditionsModule conditions: Advanced Solid Tumors (Excluding Gastric Cancer and Breast Cancer), designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: This study is Open-Label Study., enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Trastuzumab deruxtecan, outcomesModule primaryOutcomes measure: Confirmed Objective Response Rate (ORR) by Independent Central Review (ICR), secondaryOutcomes measure: Confirmed Objective Response Rate (ORR) by investigator assessment, secondaryOutcomes measure: Duration of Response (DoR) by Independent Central Review (ICR), secondaryOutcomes measure: Duration of Response (DoR) by investigator assessment, secondaryOutcomes measure: Disease control rate (DCR) by Independent Central Review (ICR), secondaryOutcomes measure: Disease control rate (DCR) by investigator assessment, secondaryOutcomes measure: Confirmed best objective response (BOR) by Independent Central Review (ICR), secondaryOutcomes measure: Confirmed best objective response (BOR) by investigator assessment, secondaryOutcomes measure: Progression-free survival (PFS) by Independent Central Review (ICR), secondaryOutcomes measure: Progression-free survival (PFS) by investigator assessment, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Occurrence of adverse events (AEs) and serious adverse events (SAEs), secondaryOutcomes measure: Pharmacokinetics (PK) of T-DXd, secondaryOutcomes measure: Immunogenicity of T-DXd, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 130 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, status: NOT_YET_RECRUITING, city: Beijing, zip: 100142, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Changchun, zip: 130021, country: China, geoPoint lat: 43.88, lon: 125.32278, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Changsha, zip: 410013, country: China, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Changzhou, zip: 213004, country: China, geoPoint lat: 31.77359, lon: 119.95401, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chengdu, zip: 610041, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chongqing, zip: 400030, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Dongyang, zip: 322100, country: China, geoPoint lat: 29.26778, lon: 120.22528, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Guangzhou, zip: 510145, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Guangzhou, zip: 510630, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Research Site, status: WITHDRAWN, city: Haikou, zip: 570311, country: China, geoPoint lat: 20.04583, lon: 110.34167, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hangzhou, zip: 310022, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Research Site, status: RECRUITING, city: Harbin, zip: 150081, country: China, geoPoint lat: 45.75, lon: 126.65, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hefei, zip: 230031, country: China, geoPoint lat: 31.86389, lon: 117.28083, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kunming, zip: 650118, country: China, geoPoint lat: 25.03889, lon: 102.71833, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lishui, zip: 323000, country: China, geoPoint lat: 28.46042, lon: 119.91029, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Nanchang, zip: 330029, country: China, geoPoint lat: 28.68396, lon: 115.85306, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Shanghai, zip: 200011, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Shanghai, zip: 200032, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Shenyang, zip: 110016, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Xuzhou, zip: 221009, country: China, geoPoint lat: 34.18045, lon: 117.15707, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Yinchuan, zip: 750004, country: China, geoPoint lat: 38.46806, lon: 106.27306, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Zhengzhou, zip: 450008, country: China, geoPoint lat: 34.75778, lon: 113.64861, hasResults: False