[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640310":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":11,"centralContacts":25,"locations":31,"responsibleParty":65,"collaborators":11,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":11,"enrollmentInfo":77,"targetDuration":11,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":90,"overallStatus":34,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Aktis Oncology, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"[225Ac]Ac-AKY-2519","EXPERIMENTAL",null,[13,14],"Drug: [225Ac]Ac-AKY-2519 (therapeutic)","Drug: [64Cu]Cu-AKY-2519 (imaging)",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":11},"DRUG","[225Ac]Ac-AKY-2519 (therapeutic)","\\[225Ac\\]Ac-AKY-2519 Injection",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"[64Cu]Cu-AKY-2519 (imaging)","\\[64Cu\\]Cu-AKY-2519 Injection",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},"Tiffany Wang, MD","CONTACT","+1-857-216-8482","AKY-2519-01inquiries@aktisoncology.com",[32,51],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Biogenix Molecular, LLC","RECRUITING","Miami","Florida","33165","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-80.19366,25.77427,{"lat":44,"lon":43},[47],{"name":48,"role":28,"phone":49,"phoneExt":11,"email":50},"Study Coordinator","786-791-1799","jjoseph@cira-health.com",{"facility":52,"status":34,"city":53,"state":54,"zip":55,"country":38,"countryCode":39,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"BAMF Health","Grand Rapids","Michigan","49503",{"type":41,"coordinates":57},[58,59],-85.66809,42.96336,{"lat":59,"lon":58},[62],{"name":48,"role":28,"phone":63,"phoneExt":11,"email":64},"616-330-2735","ResearchClinicalTeam@bamfhealth.com",{"type":66,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100640310","phase-1-a-study-of-225acac-aky-2519-in-patients-with-metastatic-castration-resistant-prostate-cancer-100640310",false,"NCT07581184","A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer","BActinium-1: A Phase 1b, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Intravenous Administration of B7-H3 Radiopharmaceutical ([225Ac]Ac-AKY-2519) in Metastatic Castration-Resistant Prostate Cancer","BActinium-1","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologic or cytologic confirmation of prostatic adenocarcinoma\n* ECOG Performance Status of 0 or 1\n* Adequate end-organ function\n* Ability to give informed consent and comply with study requirements\n* Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids\n* Castrate levels of serum testosterone (\\\u003C 50 ng\u002FdL)\n* Documented disease progression on most recent prior line of therapy, either by PSA or imaging-based progression\n* Cohort B: Received 2 or more prior doses of 177Lu-PSMA-617 (PLUVICTO)\n\nExclusion Criteria:\n\n* Prior treatment with more than 2 Androgen receptor pathway inhibitors (ARPIs) and\u002For more than 1 taxane-based therapy in the mCRPC setting\n* Prior treatment with a targeted radiotherapy\n\n  o Exception: Cohort B is required to have had at least 2 prior doses of 177Lu-PSMA-617 (PLUVICTO)\n* Prior treatment with a B7-H3 targeted therapy\n* Received an investigational agent within the previous 28 days\n* Impaired cardiac function or clinically significant cardiac disease\n* Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity","MALE","18 Years",{"count":78,"type":79},138,"ESTIMATED","INTERVENTIONAL",[82],"PHASE1","This is a Phase 1b, multi-center, open-label study to evaluate the safety, tolerability, dosimetry, and pharmacokinetics (PK) of \\[64Cu\\]Cu-AKY-2519 and\u002For \\[225Ac\\]Ac-AKY-2519, as well as the preliminary anti-tumor activity of \\[225Ac\\]Ac-AKY-2519 in participants with metastatic castration-resistant prostate cancer (mCRPC) with and without prior exposure to 177Lu-PSMA-617 (PLUVICTO™).",[85,86,87,88,89],"Castration Resistant Metastatic Prostate Cancer","Prostate Cancer","mCRPC (Metastatic Castration-resistant Prostate Cancer)","mCRPC","B7H3",[91,73,92,93],"AKY-2519","AKY-2519-01","B7-H3","2026-05-06",{"date":96,"type":97},"2026-05-12","ACTUAL",{"date":99,"type":79},"2026-07",{"date":101,"type":79},"2032-06",{"name":5,"class":6},2]