[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565072":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":227,"collaborators":29,"id":229,"slug":230,"hasResults":231,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":231,"sex":237,"minAge":238,"maxAge":29,"enrollmentInfo":239,"targetDuration":29,"studyType":242,"phases":243,"briefSummary":246,"conditions":247,"keywords":249,"overallStatus":47,"whyStopped":29,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":262},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Sacituzumab tirumotecan","EXPERIMENTAL","Participants receive intravesical Sacituzumab Tirumotecan for 6 weeks",[13,14,15],"Drug: Sacituzumab tirumotecan","Drug: Rescue medication","Drug: Supportive care measures",[17,25,30],{"type":18,"name":9,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Intravesical administration",[9],[22,23,24],"SKB264","sac-TMT","MK-2870",{"type":18,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Rescue medication","Participants are allowed to take rescue medication for stomatitis or oral mucositis. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are antihistamine, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion or steroid mouthwash (dexamethasone or equivalent), antiemetic medications, oral nystatin suspension or antifungal medications, antidiarrheal agents, antiemetic agents, opiate and non-opiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors.",[9],null,{"type":18,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Supportive care measures","Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Artificial tear drops or gel may be given as a supportive care for Ocular Surface Toxicity.",[9],[35],{"name":36,"affiliation":5,"role":37},"Medical Director","STUDY_DIRECTOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":29,"email":43},"Toll Free Number","CONTACT","1-888-577-8839","Trialsites@msd.com",[45,63,76,89,102,117,130,145,158,170,185,200,212],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Michael G Oefelein Clinical Trials ( Site 0053)","RECRUITING","Bakersfield","California","93301","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-119.01871,35.37329,{"lat":57,"lon":56},[60],{"name":61,"role":41,"phone":62,"phoneExt":29,"email":29},"Study Coordinator","661-310-1063",{"facility":64,"status":47,"city":65,"state":66,"zip":67,"country":51,"countryCode":52,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Moffitt Cancer Center ( Site 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0043)","Málaga","Andalusia","29010","Spain","ES",{"type":54,"coordinates":193},[194,195],-4.42034,36.72016,{"lat":195,"lon":194},[198],{"name":61,"role":41,"phone":199,"phoneExt":29,"email":29},"+34951032095",{"facility":201,"status":47,"city":202,"state":29,"zip":203,"country":190,"countryCode":191,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"Hospital Universitario 12 de Octubre ( Site 0042)","Madrid","28041",{"type":54,"coordinates":205},[206,207],-3.70256,40.4165,{"lat":207,"lon":206},[210],{"name":61,"role":41,"phone":211,"phoneExt":29,"email":29},"+34913908121",{"facility":213,"status":47,"city":214,"state":215,"zip":216,"country":217,"countryCode":218,"cosmosGeoPoint":219,"geoPoint":223,"contacts":224},"St Bartholomew s Hospital ( Site 0061)","London","London, City of","EC1A 7BE","United Kingdom","UK",{"type":54,"coordinates":220},[221,222],-0.12574,51.50853,{"lat":222,"lon":221},[225],{"name":61,"role":41,"phone":226,"phoneExt":29,"email":29},"+4407535510363",{"type":228,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100565072","phase-1-a-clinical-study-of-sacituzumab-tirumotecan-mk-2870-in-patients-with-bladder-cancer-mk-2870-027-100565072",false,"NCT06637423","A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)","A Phase 1\u002F2 Open-label Clinical Study to Evaluate the Safety and Efficacy of Intravesical Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (NMIBC)","TroFuse-027","Inclusion Criteria:\n\nThe key inclusion criteria include but are not limited to the following:\n\n* Has recurrent low-grade (Ta) Non-Muscle Invasive Bladder Cancer (NMIBC) in the bladder\n* Must have visible tumor by cystoscopy within 12 weeks prior to first dose\n* Has intermediate-risk NMIBC defined as 1 or more of the following risk factors:\n\n  * Multiple tumors\n  * \\>1 occurrence of low-grade NMIBC within 1 year of the current diagnosis at Screening\n  * Early recurrence (\\\u003C1 year) of the initial diagnosis of low-grade disease\n  * Solitary tumor \\>3 cm\n  * Failure of prior intravesical treatment\n* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 14 days prior to first dose\n\nExclusion Criteria:\n\nThe key exclusion criteria include but are not limited to the following:\n\n* Newly diagnosed low-grade non-muscle invasive bladder cancer (Ta NMIBC) in the bladder\n* Past or current history of high-grade (Ta or T1 or CIS) NMIBC, muscle invasive bladder cancer (MIBC) or metastatic urothelial carcinoma (UC)\n* Has a condition that would prohibit normal voiding (or hold bladder voiding for 1 to 2 hours)\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease, and\u002For blepharitis, or severe corneal disease that prevents and\u002For delays corneal healing\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Chron's disease, ulcerative colitis, or chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.","ALL","18 Years",{"count":240,"type":241},32,"ESTIMATED","INTERVENTIONAL",[244,245],"PHASE1","PHASE2","The goal of the study is to learn about the safety of Sacituzumab Tirumotecan and if people can tolerate it when given in the bladder and find the highest dose that people can take without having certain problems. Researchers will then choose a dose level of Sacituzumab Tirumotecan to use in future studies to learn how well the drug works.",[248],"Non-Muscle Invasive Bladder Cancer",[248,250,251,252],"Low Grade","Intermediate Risk","Recurrent Low-Grade","2026-06-11",{"date":255,"type":256},"2026-06-12","ACTUAL",{"date":258,"type":256},"2024-12-20",{"date":260,"type":241},"2028-07-31",{"name":5,"class":6},13]