[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524420":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":46,"collaborators":19,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":19,"eligibilityCriteria":53,"healthyVolunteers":50,"sex":54,"minAge":55,"maxAge":19,"enrollmentInfo":56,"targetDuration":19,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":19,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Shanghai Hengrui Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SHR-2005","EXPERIMENTAL","Only one arm with SHR-2005",[13],"Drug: SHR-2005",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"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.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Shouwei Zhao","CONTACT","0518-82342973","shouwei.zhao@hengrui.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Fudan University Zhongshan Hospital","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":36,"coordinates":37},"Point",[38,39],121.45806,31.22222,{"lat":39,"lon":38},[42],{"name":43,"role":23,"phone":44,"phoneExt":19,"email":45},"Jianming Guo, Doctor","+86-13681971306","Guo.jianming@zs-hospital.sh.cn",{"type":47,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100524420","phase-1-a-phase-i-clinical-study-of-shr-2005-intravesical-instillation-in-the-treatment-of-intermediate-and-high-risk-non-muscle-invasive-bladder-cancer-nmibc-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":57,"type":58},170,"ESTIMATED","INTERVENTIONAL",[61],"PHASE1","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.",[64],"Intermediate and High-risk Non-muscle Invasive Bladder Cancer","2024-11-28",{"date":67,"type":68},"2024-12-03","ACTUAL",{"date":70,"type":68},"2023-11-28",{"date":72,"type":58},"2027-09-30",{"name":5,"class":6},1]