[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intermediate-and-high-risk-non-muscle-invasive-bladder-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intermediate-and-high-risk-non-muscle-invasive-bladder-cancer":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":5},"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":18,"type":19},170,"ESTIMATED","INTERVENTIONAL",[22],"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.",[25],"Intermediate and High-risk Non-muscle Invasive Bladder Cancer","RECRUITING","2024-11-28",{"date":29,"type":30},"2024-12-03","ACTUAL",{"date":32,"type":30},"2023-11-28",{"date":34,"type":19},"2027-09-30",{"name":36,"class":37},"Shanghai Hengrui Pharmaceutical Co., Ltd.","INDUSTRY"]