[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612944":3},{"organization":4,"outcomesModule":7,"designInfo":16,"detailedDescription":15,"studyPopulation":15,"armGroups":23,"interventions":30,"overallOfficials":37,"centralContacts":42,"locations":50,"responsibleParty":66,"collaborators":15,"id":68,"slug":15,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":15,"enrollmentInfo":77,"targetDuration":15,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":94,"whyStopped":15,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Institut Cancerologie de l'Ouest","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":15},[9,13],{"measure":10,"description":11,"timeFrame":12},"To determine the Maximum Tolerated Dose (MTD) of ATO-101™.","The primary endpoint is the occurrence of dose-limiting toxicities (DLTs) during the DLT observation period.","15 days",{"measure":14,"description":11,"timeFrame":12},"To determine the Recommended Dose for Expansion (RDE) of ATO-101™.",null,{"allocation":17,"interventionModel":18,"interventionModelDescription":19,"primaryPurpose":20,"observationalModel":15,"timePerspective":15,"maskingInfo":21},"NA","SINGLE_GROUP","ATO-101™ is an anti-CA-IX antibody (Girentuximab) radiolabeled with an alpha-emitting radionuclides (astatine-211)","TREATMENT",{"masking":22,"maskingDescription":15,"whoMasked":15},"NONE",[24],{"label":25,"type":26,"description":27,"interventionNames":28},"ATO-101™","EXPERIMENTAL","\\[211At\\]At-Girentuximab (ATO-101™) intravesical administration",[29],"Drug: ATO-101™",[31],{"type":32,"name":25,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","The study drug: \\[211At\\]At-Girentuximab (ATO-101™) is administered via intravesical instillation",[25],[36],"[211At]At-Girentuximab",[38],{"name":39,"affiliation":40,"role":41},"Caroline ROUSSEAU, MD, PhD","Institut de Cancérologie de l'OUEST _ ICO","PRINCIPAL_INVESTIGATOR",[43,47],{"name":39,"role":44,"phone":45,"phoneExt":15,"email":46},"CONTACT","+33 2 40 67 99 00","caroline.rousseau@ico.unicancer.fr",{"name":48,"role":44,"phone":45,"phoneExt":15,"email":49},"Nadia ALLAM, PhD","nadia.allam@ico.unicancer.fr",[51],{"facility":52,"status":15,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Institut de Cancérologie de l'Ouest","Saint-Herblain","Loire Atlantique","44800","France","FR",{"type":59,"coordinates":60},"Point",[61,62],-1.651,47.21154,{"lat":62,"lon":61},[65],{"name":39,"role":44,"phone":45,"phoneExt":15,"email":46},{"type":67,"investigatorFullName":15,"investigatorTitle":15,"investigatorAffiliation":15,"oldNameTitle":15,"oldOrganization":15},"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":78,"type":79},24,"ESTIMATED","INTERVENTIONAL",[82],"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.",[85],"Bladder Cancer",[87,88,89,90,91,92,93,36,25],"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":97,"type":98},"2026-06-08","ACTUAL",{"date":100,"type":79},"2027-01",{"date":102,"type":79},"2030-01",{"name":5,"class":6},1]