[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Aktis Oncology, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"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":19,"type":20},138,"ESTIMATED","INTERVENTIONAL",[23],"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™).",[26,27,28,29,30],"Castration Resistant Metastatic Prostate Cancer","Prostate Cancer","mCRPC (Metastatic Castration-resistant Prostate Cancer)","mCRPC","B7H3",[32,14,33,34],"AKY-2519","AKY-2519-01","B7-H3","RECRUITING","2026-05-06",{"date":38,"type":39},"2026-05-12","ACTUAL",{"date":41,"type":20},"2026-07",{"date":43,"type":20},"2032-06",{"name":45,"class":46},"Aktis Oncology, Inc.","INDUSTRY",{"id":48,"slug":4,"hasResults":10,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":10,"sex":53,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":72,"locationsCount":73},"100594490","NCT07020117","A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors","NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Histologic or cytologic confirmation of locally advance or metastatic disease\n* Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1\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* Documented disease progression on prior line of therapy for metastatic disease\n\nExclusion Criteria:\n\n* Prior treatment with a therapeutic radiopharmaceutical\n* Prior treatment with a Nectin-4 targeted therapy, except enfortumab vedotin\n* Received an investigational agent within the previous 28days\n* Prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy in the 3 weeks prior to study treatment\n* Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity","ALL",{"count":55,"type":20},150,[23],"This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical (\\[225Ac\\]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.",[59,60,61,62,63,64,65],"Urothelial Carcinoma Bladder","Triple Negative Breast Cancer (TNBC)","Hormone Receptor Positive Breast Adenocarcinoma","Non Small Cell Lung Cancer","Cervical Adenocarcinoma","Colorectal Adenocarcinoma","Head and Neck Cancer","2026-04-17",{"date":68,"type":39},"2026-04-21",{"date":70,"type":39},"2025-08-22",{"date":43,"type":20},{"name":45,"class":46},9,""]