[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612944":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":51,"collaborators":30,"id":53,"slug":30,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":30,"enrollmentInfo":62,"targetDuration":30,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":79,"whyStopped":30,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Institut Cancerologie de l'Ouest","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ATO-101™","EXPERIMENTAL","\\[211At\\]At-Girentuximab (ATO-101™) intravesical administration",[13],"Drug: ATO-101™",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","The study drug: \\[211At\\]At-Girentuximab (ATO-101™) is administered via intravesical instillation",[9],[20],"[211At]At-Girentuximab",[22],{"name":23,"affiliation":24,"role":25},"Caroline ROUSSEAU, MD, PhD","Institut de Cancérologie de l'OUEST _ ICO","PRINCIPAL_INVESTIGATOR",[27,32],{"name":23,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","+33 2 40 67 99 00",null,"caroline.rousseau@ico.unicancer.fr",{"name":33,"role":28,"phone":29,"phoneExt":30,"email":34},"Nadia ALLAM, PhD","nadia.allam@ico.unicancer.fr",[36],{"facility":37,"status":30,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Institut de Cancérologie de l'Ouest","Saint-Herblain","Loire Atlantique","44800","France","FR",{"type":44,"coordinates":45},"Point",[46,47],-1.651,47.21154,{"lat":47,"lon":46},[50],{"name":23,"role":28,"phone":29,"phoneExt":30,"email":31},{"type":52,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100612944",false,"NCT07260162","Evaluation of ATO-101™ in Patients With Non-Muscle-Invasive Bladder Cancer (PERSEVERANCE EU)","A First In Human Phase I Trial Evaluating Safety, Tolerability and Response of [211At]At-Girentuximab (ATO-101™) in Patients With Non-Muscle-Invasive Bladder Cancer Refractory to Standard Treatment","PERSEVERANCE","Inclusion Criteria:\n\n* Performance Status (PS): 0 or 1.\n* Patient experiencing relapse following standard treatment (BCG therapy with or without Mitomycin), before radical surgery which is being considered as a therapeutic option.\n* Clinical evidence of NMIBC based on cystoscopy and proven histologically of papillary tumours.\n* Histologically confirmed bladder cancer patients relapsing without muscle invasion.\n* Negative serum\u002Furine pregnancy test prior to ATO-101™ administration for female patient of childbearing potential.\n* Consent to use a contraception method for at least 3 months after administration of ATO-101™.\n* Adequate organ function confirmed by laboratory tests results allowing for safe administration of ATO-101™.\n\nExclusion Criteria:\n\n* Patient with urinary incontinence.\n* Patient treated with anticoagulant or platelet antiaggregant therapies.\n* Symptoms of urine infection.\n* Patient with urethral stenosis.\n* Patient with valvular heart disease.\n* No history of congestive heart failure.\n* Known hypersensitivity to Girentuximab.\n* Exposure to any experimental diagnostic or therapeutic drug within 30 days prior the date of planned administration of ATO-101™.\n* Serious non-malignant disease that may interfere with the objectives of the study or with the safety or compliance of the patient as judged by the investigator.\n* Concomitant cancer in the past 5 years except cutaneous cancers (except melanoma) and in situ carcinoma in past 3 years.\n* Prior chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), immunotherapy within 21 days of ATO-101™ administration.\n* Pregnant or likely to be pregnant or nursing patient.","ALL","18 Years",{"count":63,"type":64},24,"ESTIMATED","INTERVENTIONAL",[67],"PHASE1","Non-Muscle-Invasive Bladder cancer (NMIBC) tumours often recur despite TransUrethral Resection of Bladder (TURB) and Bacillus Calmette-Guerin (BCG) intravesical instillations, and have no effective conservative treatment options. Alpha emitters like Astatine-211 (211At), due to their short path and short half-life, show promise for superficial targets such as NMIBC.\n\nCarbonic anhydrase IX (CAIX), overexpressed in 70-90% of NMIBC cases but absent in healthy tissues, is an ideal target.\n\nA clinical feasibility Positron emission tomography-computed tomography (PET\u002FCT) imaging study (Pertinence, NCT04897763) was conducted at Institut de cancérologie Ouest (ICO) in six patients using Girentuximab labelled with Zirconium-89 (\\[89Zr\\]Zr-girentuximab). It demonstrated successful tracer targeting and no radioactive leakage beyond the bladder following intravesical instillation. The study also confirmed the absence of toxicity, contamination, or significant additional staff radiation exposure.\n\nATO-101™ (\\[²¹¹At\\]At-girentuximab) could enable localised tumour destruction while preserving the bladder in patients with BCG-unresponsive NMIBC. The ongoing First In Human (FIH) study evaluate the safety of ATO-101™ in patients with BCG-unresponsive NMIBC.",[70],"Bladder Cancer",[72,73,74,75,76,77,78,20,9],"Non-Muscle-Invasive Bladder cancer (NMIBC)","Girentuximab","Astatine 211","Phase I","First In Human (FIH)","Carbonic anhydrase IX (CAIX)","Intravesical instillation","NOT_YET_RECRUITING","2026-06-04",{"date":82,"type":83},"2026-06-08","ACTUAL",{"date":85,"type":64},"2027-01",{"date":87,"type":64},"2030-01",{"name":5,"class":6},1]