[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524420":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":11,"studyPopulation":11,"armGroups":52,"interventions":59,"overallOfficials":11,"centralContacts":64,"locations":70,"responsibleParty":90,"collaborators":11,"id":92,"slug":11,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":11,"eligibilityCriteria":96,"healthyVolunteers":93,"sex":97,"minAge":98,"maxAge":11,"enrollmentInfo":99,"targetDuration":11,"studyType":102,"phases":103,"briefSummary":48,"conditions":105,"keywords":11,"overallStatus":73,"whyStopped":11,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Shanghai Hengrui Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":11},[9,13,15,18],{"measure":10,"description":11,"timeFrame":12},"Incidence of dose limiting toxicities (DLTs)",null,"From Day 1 to Day 21",{"measure":14,"description":11,"timeFrame":12},"Maximum tolerated dose (MTD)",{"measure":16,"description":11,"timeFrame":17},"Incidence and severity of adverse events (AEs) ([CTCAE] v5.0)","From Day 1 to 90 days after last dose",{"measure":19,"description":11,"timeFrame":17},"RP2D（Recommended Phase 2 dose）",[21,25,28,31,34,38,40,42],{"measure":22,"description":23,"timeFrame":24},"PK parameter: Tmax of SHR-2005","Time to maximum concentration of SHR-2005","approximately 24 months",{"measure":26,"description":27,"timeFrame":24},"PK parameter: Cmax of SHR-2005","Maximum concentration of SHR-2005",{"measure":29,"description":30,"timeFrame":24},"PK parameter: AUC0-∞ of SHR-2005","area under the concentration-time curve from time 0 to infinity of SHR-2005",{"measure":32,"description":33,"timeFrame":24},"Immunogenicity of SHR-2005","Anti- SHR-2005 antibody (ADA)",{"measure":35,"description":36,"timeFrame":37},"Duration of response (DoR)","Evaluated using RECIST 1.1","approximately within 36 months",{"measure":39,"description":36,"timeFrame":37},"Disease control rate (DCR)",{"measure":41,"description":36,"timeFrame":37},"Progression-free survival (PFS)",{"measure":43,"description":44,"timeFrame":24},"Amount_recovered and Percent_recovered","The Amount \\_ recovered and Percent \\_ recovered of SHR-2005 in urine after intravesical instillation.",{"allocation":46,"interventionModel":47,"interventionModelDescription":48,"primaryPurpose":49,"observationalModel":11,"timePerspective":11,"maskingInfo":50},"NA","SINGLE_GROUP","This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle invasive bladder cancer.","TREATMENT",{"masking":51,"maskingDescription":11,"whoMasked":11},"NONE",[53],{"label":54,"type":55,"description":56,"interventionNames":57},"SHR-2005","EXPERIMENTAL","Only one arm with SHR-2005",[58],"Drug: SHR-2005",[60],{"type":61,"name":54,"description":62,"armGroupLabels":63,"otherNames":11},"DRUG","In dose Escalation: Four dose levels are preset. The administration cycle included 6 times of induction perfusion period and 15 times of maintenance perfusion period.\n\nIn indication Expansion: Indications will be selected to evaluate preliminary efficacy.",[54],[65],{"name":66,"role":67,"phone":68,"phoneExt":11,"email":69},"Shouwei Zhao","CONTACT","0518-82342973","shouwei.zhao@hengrui.com",[71],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Fudan University Zhongshan Hospital","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":80,"coordinates":81},"Point",[82,83],121.45806,31.22222,{"lat":83,"lon":82},[86],{"name":87,"role":67,"phone":88,"phoneExt":11,"email":89},"Jianming Guo, Doctor","+86-13681971306","Guo.jianming@zs-hospital.sh.cn",{"type":91,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100524420",false,"NCT06108492","A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)","Inclusion Criteria:\n\n1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;\n2. ≥18 years of age, either sex;\n3. Previous pathological biopsy was diagnosed as intermediate or high-risk NMIBC ;\n4. ECOG performance status of 0-1;\n5. Life expectancy ≥ 2 years;\n6. Adequate bone marrow and organ function.\n\nExclusion Criteria:\n\n1. Received TURBT or other surgical treatment or radiotherapy for bladder lesions within 2 weeks before the first administration;\n2. Patients who were receiving treatment in other clinical trials or less than 4 weeks from the end of the first administration in this study;\n3. History of serious cardiovascular and cerebrovascular diseases;\n4. Severe infection within 2 weeks prior to the first dose;\n5. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0;\n6. Oversize surgery or severe trauma within 4 weeks before the first use of research drugs;\n7. Previously received any TNFR agonist antibody therapy, such as OX40, CD137, CD27, CD357 antibodies.","ALL","18 Years",{"count":100,"type":101},170,"ESTIMATED","INTERVENTIONAL",[104],"PHASE1",[106],"Intermediate and High-risk Non-muscle Invasive Bladder Cancer","2024-11-28",{"date":109,"type":110},"2024-12-03","ACTUAL",{"date":112,"type":110},"2023-11-28",{"date":114,"type":101},"2027-09-30",{"name":5,"class":6},1]