[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545157":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":46,"studyPopulation":11,"armGroups":47,"interventions":54,"overallOfficials":11,"centralContacts":62,"locations":68,"responsibleParty":146,"collaborators":11,"id":148,"slug":11,"hasResults":149,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":11,"eligibilityCriteria":153,"healthyVolunteers":149,"sex":154,"minAge":155,"maxAge":156,"enrollmentInfo":157,"targetDuration":11,"studyType":160,"phases":161,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":71,"whyStopped":11,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"RemeGen Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":11},[9,13,17,20],{"measure":10,"description":11,"timeFrame":12},"Incidence of dose-limiting toxicity(DLT) (Phase I)",null,"Approximately 21 days",{"measure":14,"description":15,"timeFrame":16},"Incidence of Adverse event (Phase I)","According to the NCI CTCAE V5.0, to evaluate safety including adverse event rate and adverse event grade","Approximately 1 years",{"measure":18,"description":19,"timeFrame":12},"Recommended Phase II Dose(RP2D)","Assessed based on the Incidence of DLT",{"measure":21,"description":19,"timeFrame":12},"Maximum Tolerated Dosage(MTD)",[23,27,30,33,36],{"measure":24,"description":25,"timeFrame":26},"Disease-free survival (DFS) rates","Disease-free survival (DFS) rates was defined as the time from the date of first study treatment to the time of the subject's first high-grade Ta, T1 of any grade, CIS lasting greater than or equal to 6 months, new carcinoma in situ (CIS), cystectomy, disease progression, or death from any cause","Up to approximately 2 years",{"measure":28,"description":29,"timeFrame":26},"Duration of response (DOR)","Defined as the time from the start of the first assessment of CR to the first assessment of high grade Ta, any grade of T1, new CIS, disease progression, cystectomy, or death from any cause",{"measure":31,"description":32,"timeFrame":26},"Disitamab Vedotin anti-drug antibody (ADA)","The number and proportion of anti-drug antibody (ADA)-positive subjects were analyzed according to dose group and time point.",{"measure":34,"description":35,"timeFrame":16},"PK of enfortumab vedotin: Maximum concentration (Cmax)","Cmax will be recorded from the PK blood samples collected.",{"measure":37,"description":38,"timeFrame":39},"PK of enfortumab vedotin: Trough concentration (Ctrough)","Ctrough will be recorded from the PK blood samples collected.","Approximately 1 year",{"allocation":41,"interventionModel":42,"interventionModelDescription":11,"primaryPurpose":43,"observationalModel":11,"timePerspective":11,"maskingInfo":44},"NA","SINGLE_GROUP","TREATMENT",{"masking":45,"maskingDescription":11,"whoMasked":11},"NONE","This is a single-arm, multicenter phase I\u002FII clinical study to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2.",[48],{"label":49,"type":50,"description":51,"interventionNames":52},"Disitamab Vedotin Intravesical instiliations :Dose escalation cohort","EXPERIMENTAL","Participants will receive Disitamab Vedotin for injection Intravesical instiliations into the bladder for 1 hour, D1, once a week.",[53],"Drug: Disitamab Vedotin for injection",[55],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"DRUG","Disitamab Vedotin for injection","Intravesical instiliations into the bladder",[49],[61],"RC48",[63],{"name":64,"role":65,"phone":66,"phoneExt":11,"email":67},"Hong Luo","CONTACT","+8610-58075763","hong.luo@remegen.com",[69,85,98,110,122,134],{"facility":70,"status":71,"city":72,"state":73,"zip":11,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Sun Yat-sen Memorial Hospital,SunYat-sen University","RECRUITING","Guangzhou","Guangdong","China","CN",{"type":77,"coordinates":78},"Point",[79,80],113.25,23.11667,{"lat":80,"lon":79},[83],{"name":84,"role":65,"phone":11,"phoneExt":11,"email":11},"Tianxin Lin, Ph.D",{"facility":86,"status":87,"city":88,"state":89,"zip":11,"country":74,"countryCode":75,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Tongji Hospital","NOT_YET_RECRUITING","Wuhan","Hubei",{"type":77,"coordinates":91},[92,93],114.26667,30.58333,{"lat":93,"lon":92},[96],{"name":97,"role":65,"phone":11,"phoneExt":11,"email":11},"Shaogang Wang, M.D",{"facility":99,"status":71,"city":100,"state":101,"zip":11,"country":74,"countryCode":75,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Hunan Cancer hospital","Changsha","Hunan",{"type":77,"coordinates":103},[104,105],112.97087,28.19874,{"lat":105,"lon":104},[108],{"name":109,"role":65,"phone":11,"phoneExt":11,"email":11},"Shusuan Jiang, M.D",{"facility":111,"status":87,"city":112,"state":113,"zip":11,"country":74,"countryCode":75,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"The first affiliated hospital with nanjing medical universtity","Nanjing","Jiangsu",{"type":77,"coordinates":115},[116,117],118.77778,32.06167,{"lat":117,"lon":116},[120],{"name":121,"role":65,"phone":11,"phoneExt":11,"email":11},"qiang Lv, M.D",{"facility":123,"status":87,"city":124,"state":125,"zip":11,"country":74,"countryCode":75,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"West China Hospital","Chengdu","Sichuan",{"type":77,"coordinates":127},[128,129],104.06667,30.66667,{"lat":129,"lon":128},[132],{"name":133,"role":65,"phone":11,"phoneExt":11,"email":11},"Peng Zhang, M.D",{"facility":135,"status":87,"city":136,"state":137,"zip":11,"country":74,"countryCode":75,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Tianjin Medical University Second Hospital","Tianjin","Tianjin Municipality",{"type":77,"coordinates":139},[140,141],117.17667,39.14222,{"lat":141,"lon":140},[144],{"name":145,"role":65,"phone":11,"phoneExt":11,"email":11},"Hailong Hu, M.D",{"type":147,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100545157",false,"NCT06378242","To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2","An Single-arm, Multicenter Phase I\u002FII Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2","Inclusion Criteria:\n\n1. Voluntary consent to participate in the study and signed the informed consent form.\n2. Male or female, age 18-75 years (including both).\n3. Histologic confirmed non-muscle invasive bladder urothelial carcinoma (NMIBC), and the risk group met the high-risk (including very high-risk) group.\n\n   Note: High-risk NMIBC is a high-grade \u002F G3 tumor meeting any of the following:\n\n   a.Carcinoma in situ (CIS) b. T1 stage c. diameter\\>3cm d.Multiple tumors, or recurrent tumors.\n4. Absence of resectable disease（Ta and\u002For T1 disease） after transurethral resection (TURBT) procedures (residual CIS acceptable;\n5. The urologist assessed that radical surgery for bladder cancer was not suitable or the subject refused radical surgery for bladder cancer.\n6. Tumor tissue samples were detected by immunohistochemistry (IHC) to satisfy HER2 expression of 1+, 2+ or 3+.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n8. Adequate heart, bone marrow, liver, kidney and coagulation function\n\nExclusion Criteria:\n\n* 1\\. Invasive bladder cancer (T2 and above) and \u002F or with regional lymph node and distant metastasis.\n\n  2\\. Combined urothelial carcinoma outside the bladder (i. e., urethra, ureter or renal pelvis).\n\n  3\\. Any other antitumor therapy received within 4 weeks before study administration, .\n\n  4 Subjects plan to undergo major surgery during the study or within 4 weeks before the first dose.\n\n  5, Known allergic to DV and its components or to any excipients.","ALL","18 Years","75 Years",{"count":158,"type":159},24,"ESTIMATED","INTERVENTIONAL",[162,163],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2",[166],"High-risk Non-muscle Invasive Bladder Cancer",[168,169,170],"HER2-expression","High-risk non-muscle invasive bladder cancer","intravesical instiliations","2024-07-09",{"date":173,"type":174},"2024-07-11","ACTUAL",{"date":176,"type":174},"2024-06-14",{"date":178,"type":159},"2029-12-31",{"name":5,"class":6},6]