[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563202":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":42,"responsibleParty":137,"collaborators":31,"id":139,"slug":140,"hasResults":141,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":31,"eligibilityCriteria":145,"healthyVolunteers":141,"sex":146,"minAge":147,"maxAge":31,"enrollmentInfo":148,"targetDuration":31,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":45,"whyStopped":31,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"fullName":5,"class":6},"Amgen","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A - Xaluritamig","EXPERIMENTAL","Xaluritamig will be administered prior to radical prostatectomy.",[13],"Drug: Xaluritamig",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort B - Xaluritamig with an Oral GnRH Antagonist","Xaluritamig will be administered prior to radical prostatectomy. Participants will also receive an oral GnRH antagonist continuously up to the time of planned radical prostatectomy.",[13,18],"Drug: GnRH Antagonist",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Xaluritamig","Intravenous (IV) infusion",[9,15],[26],"AMG 509",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"GnRH Antagonist","Oral administration",[15],null,[33],{"name":34,"affiliation":5,"role":35},"MD","STUDY_DIRECTOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":31,"email":41},"Amgen Call Center","CONTACT","866-572-6436","medinfo@amgen.com",[43,57,67,77,87,97,107,117,128],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":31},"University of California San Francisco","RECRUITING","San Francisco","California","94143","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-122.41942,37.77493,{"lat":55,"lon":54},{"facility":58,"status":45,"city":59,"state":60,"zip":61,"country":49,"countryCode":50,"cosmosGeoPoint":62,"geoPoint":66,"contacts":31},"Washington University","St Louis","Missouri","63110",{"type":52,"coordinates":63},[64,65],-90.19789,38.62727,{"lat":65,"lon":64},{"facility":68,"status":45,"city":69,"state":70,"zip":71,"country":49,"countryCode":50,"cosmosGeoPoint":72,"geoPoint":76,"contacts":31},"The Ohio State University","Columbus","Ohio","43210",{"type":52,"coordinates":73},[74,75],-82.99879,39.96118,{"lat":75,"lon":74},{"facility":78,"status":45,"city":79,"state":80,"zip":81,"country":49,"countryCode":50,"cosmosGeoPoint":82,"geoPoint":86,"contacts":31},"Thomas Jefferson University","Philadelphia","Pennsylvania","19107",{"type":52,"coordinates":83},[84,85],-75.16362,39.95238,{"lat":85,"lon":84},{"facility":88,"status":45,"city":89,"state":90,"zip":91,"country":49,"countryCode":50,"cosmosGeoPoint":92,"geoPoint":96,"contacts":31},"Carolina Urologic Research Center","Myrtle Beach","South Carolina","29572",{"type":52,"coordinates":93},[94,95],-78.88669,33.68906,{"lat":95,"lon":94},{"facility":98,"status":45,"city":99,"state":100,"zip":101,"country":49,"countryCode":50,"cosmosGeoPoint":102,"geoPoint":106,"contacts":31},"Fred Hutchinson Cancer Center","Seattle","Washington","98109-1023",{"type":52,"coordinates":103},[104,105],-122.33207,47.60621,{"lat":105,"lon":104},{"facility":108,"status":45,"city":109,"state":110,"zip":111,"country":49,"countryCode":50,"cosmosGeoPoint":112,"geoPoint":116,"contacts":31},"Medical College of Wisconsin","Milwaukee","Wisconsin","53226",{"type":52,"coordinates":113},[114,115],-87.90647,43.0389,{"lat":115,"lon":114},{"facility":118,"status":45,"city":119,"state":31,"zip":120,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":127,"contacts":31},"Universitaetsklinikum Essen","Essen","45147","Germany","DE",{"type":52,"coordinates":124},[125,126],7.01228,51.45657,{"lat":126,"lon":125},{"facility":129,"status":45,"city":130,"state":31,"zip":131,"country":121,"countryCode":122,"cosmosGeoPoint":132,"geoPoint":136,"contacts":31},"Universitaetsklinikum Hamburg Eppendorf","Hamburg","20246",{"type":52,"coordinates":133},[134,135],9.99302,53.55073,{"lat":135,"lon":134},{"type":138,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100563202","phase-1-evaluation-of-neoadjuvant-xaluritamig-in-localized-prostate-cancer-100563202",false,"NCT06613100","Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer","A Phase 1b, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, and Feasibility of Neoadjuvant Xaluritamig Therapy Prior to Radical Prostatectomy in Subjects With Newly Diagnosed Localized Intermediate or High-Risk Prostate Cancer","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all the following criteria apply:\n\n* Participants planned to undergo radical prostatectomy.\n* Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features. Intermediate- or high-risk localized prostate cancer, defined as:\n\n  * Gleason score of 4+3 or higher AND initial PSA (iPSA) \\>10 OR\n  * Clinically advanced (cT3) on Magnetic Resonance Imaging (MRI) obtained within 3 months prior to screening AND\u002FOR\n  * Positive locoregional lymph nodes as detected by prostate-specific membrane antigen-positron emission tomography (PSMA-PET) scans OR ≤ 5 local lymph nodes on MRI can be enrolled.\n* Participants must have undergone a PSMA-PET (CT or MRI) scan within 3 months prior to screening as part of the standard of care (SOC).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Prior treatment for participant's prostate cancer.\n\n  \\- Exception: Participants intended for enrollment in cohort B may have received an oral GnRH antagonist up to 3 months prior to the start of screening.\n* Any evidence of metastases outside of the surgical resection field identified by conventional imaging or PSMA-PET scans.\n* Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.\n* Participants with symptoms and\u002For clinical signs and\u002For radiographic signs that indicate an acute and\u002For uncontrolled active systemic infection within 7 days prior to the first dose of study treatment:\n\n  \\- Participant has known active infection requiring antibiotic treatment. Upon completion of antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint.\n* Recent history of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis) within 6 and 3 months prior to the first dose of study treatment, respectively. Note: Participants with a history of venous thrombosis must be on stable anti-coagulation.\n* Myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association ≥ class II) within 12 months of first dose of xaluritamig with the exception of ischemia or non-ST segment elevation myocardial infarction controlled with stent placement more than 6 months prior to first dose of xaluritamig.\n* Requirement for chronic systemic corticosteroid therapy unless stopped (with adequate tapering) within 7 days prior to dosing.\n* Currently receiving treatment in another investigational device or drug study, or less than 4 weeks (since ending treatment on another investigational device or drug study\\[ies\\]). Other investigational procedures and participation in observational research studies while participating in this study are excluded with the exception of investigational scans.","MALE","18 Years",{"count":149,"type":150},40,"ESTIMATED","INTERVENTIONAL",[153],"PHASE1","The primary objectives of this study are to evaluate the safety and tolerability of xaluritamig administered as monotherapy or in combination with an oral Gonadotropin-releasing Hormone (GnRH) antagonist in the neoadjuvant setting followed by radical prostatectomy, and to evaluate the feasibility and safety of a radical prostatectomy following xaluritamig administered as monotherapy or in combination with an oral GnRH antagonist in the neoadjuvant setting.",[156],"Prostate Cancer",[22,158,159,156,160,161,162,163],"AMG509","Localized Prostate Cancer","Neoadjuvant Therapy","Immunotherapy","T-Cell Engager","STEAP1","2026-07-30",{"date":166,"type":167},"2026-07-31","ACTUAL",{"date":169,"type":167},"2024-11-25",{"date":171,"type":150},"2030-03-04",{"name":5,"class":6},9]