[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523392":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":60,"centralContacts":64,"locations":70,"responsibleParty":223,"collaborators":49,"id":225,"slug":226,"hasResults":227,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":49,"eligibilityCriteria":231,"healthyVolunteers":227,"sex":232,"minAge":233,"maxAge":49,"enrollmentInfo":234,"targetDuration":49,"studyType":237,"phases":238,"briefSummary":240,"conditions":241,"keywords":49,"overallStatus":73,"whyStopped":49,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":252},{"fullName":5,"class":6},"Janssen Research & Development, LLC","INDUSTRY",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1 (Dose Escalation)","EXPERIMENTAL","Participants will receive JNJ-78278343 + JNJ-87189401 escalated sequentially in Part 1 to select a recommended Phase 2 regimen (RP2R).",[13,14],"Drug: JNJ-78278343","Drug: JNJ-87189401",{"label":16,"type":10,"description":17,"interventionNames":18},"Part 2 (Dose Expansion)","Participants with different disease settings in Parts 2A and 2B will receive JNJ-78278343+JNJ-87189401 at the RP2R selected in Part 1. Participants in Part 2C will receive apalutamide plus continued treatment with JNJ-87189401+JNJ-78278343 doublet.",[13,14,19],"Drug: Apalutamide",{"label":21,"type":10,"description":22,"interventionNames":23},"Part 3","Participants will receive JNJ-78278343 + JNJ-87189401 at one or more RP2R (s) selected in Part 1 along with standard of care (SOC) treatment with lutetium Lu-177 vipivotide tetraxetan. Dosing of JNJ-78278343+JNJ-87189401 will be escalated sequentially, as per study evaluation team (SET) decision.",[13,14,24],"Drug: Lutetium Lu-177 Vipivotide Tetraxetan",{"label":26,"type":10,"description":27,"interventionNames":28},"Part 4","Participants will receive JNJ-78278343 + JNJ-87189401 at one or more RP2R (s) along with JNJ-101556143. Dosing of JNJ-78278343+JNJ-87189401 along with JNJ-101556143 will be escalated sequentially to determine the RP2R of the combinations.",[13,14,29],"Drug: JNJ-101556143",[31,39,45,50,54],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","JNJ-78278343","JNJ-78278343 will be administered.",[9,16,21,26],[37,38],"KLK2-CD3","Pasritamig",{"type":32,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"JNJ-87189401","JNJ-87189401 will be administered.",[9,16,21,26],[44],"PSMAxCD28",{"type":32,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Apalutamide","Apalutamide will be administered.",[16],null,{"type":32,"name":51,"description":52,"armGroupLabels":53,"otherNames":49},"Lutetium Lu-177 Vipivotide Tetraxetan","Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment.",[21],{"type":32,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"JNJ-101556143","JNJ-101556143 will be administered.",[26],[59],"HLD-0915",[61],{"name":62,"affiliation":5,"role":63},"Janssen Research & Development, LLC Clinical Trial","STUDY_DIRECTOR",[65],{"name":66,"role":67,"phone":68,"phoneExt":49,"email":69},"Study Contact","CONTACT","844-434-4210","Participate-In-This-Study1@its.jnj.com",[71,85,95,105,115,124,134,144,154,164,173,183,194,203,212],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":49},"University of Colorado Anschutz Medical Campus","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":80,"coordinates":81},"Point",[82,83],-104.83192,39.72943,{"lat":83,"lon":82},{"facility":86,"status":73,"city":87,"state":88,"zip":89,"country":77,"countryCode":78,"cosmosGeoPoint":90,"geoPoint":94,"contacts":49},"Emory University Winship Cancer Institute","Atlanta","Georgia","30322",{"type":80,"coordinates":91},[92,93],-84.38798,33.749,{"lat":93,"lon":92},{"facility":96,"status":73,"city":97,"state":98,"zip":99,"country":77,"countryCode":78,"cosmosGeoPoint":100,"geoPoint":104,"contacts":49},"University Of Minnesota","Minneapolis","Minnesota","55455",{"type":80,"coordinates":101},[102,103],-93.26384,44.97997,{"lat":103,"lon":102},{"facility":106,"status":73,"city":107,"state":108,"zip":109,"country":77,"countryCode":78,"cosmosGeoPoint":110,"geoPoint":114,"contacts":49},"START New Jersey","East Brunswick","New Jersey","08816",{"type":80,"coordinates":111},[112,113],-74.41598,40.42788,{"lat":113,"lon":112},{"facility":116,"status":73,"city":117,"state":117,"zip":118,"country":77,"countryCode":78,"cosmosGeoPoint":119,"geoPoint":123,"contacts":49},"Herbert Irving Comprehensive Cancer Center Columbia University Medical Center","New York","10032",{"type":80,"coordinates":120},[121,122],-74.00597,40.71427,{"lat":122,"lon":121},{"facility":125,"status":73,"city":126,"state":127,"zip":128,"country":77,"countryCode":78,"cosmosGeoPoint":129,"geoPoint":133,"contacts":49},"Oregon Health And Science University","Portland","Oregon","97239",{"type":80,"coordinates":130},[131,132],-122.67621,45.52345,{"lat":132,"lon":131},{"facility":135,"status":73,"city":136,"state":137,"zip":138,"country":77,"countryCode":78,"cosmosGeoPoint":139,"geoPoint":143,"contacts":49},"Sidney Kimmel Cancer Center - Jefferson Health","Philadelphia","Pennsylvania","19107",{"type":80,"coordinates":140},[141,142],-75.16362,39.95238,{"lat":142,"lon":141},{"facility":145,"status":73,"city":146,"state":147,"zip":148,"country":77,"countryCode":78,"cosmosGeoPoint":149,"geoPoint":153,"contacts":49},"Tennessee Oncology","Nashville","Tennessee","37203",{"type":80,"coordinates":150},[151,152],-86.78444,36.16589,{"lat":152,"lon":151},{"facility":155,"status":73,"city":156,"state":157,"zip":158,"country":77,"countryCode":78,"cosmosGeoPoint":159,"geoPoint":163,"contacts":49},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":80,"coordinates":160},[161,162],-95.36327,29.76328,{"lat":162,"lon":161},{"facility":165,"status":73,"city":166,"state":157,"zip":167,"country":77,"countryCode":78,"cosmosGeoPoint":168,"geoPoint":172,"contacts":49},"South Texas Accelerated Research Therapeutics, LLC (START)","San Antonio","78229",{"type":80,"coordinates":169},[170,171],-98.49363,29.42412,{"lat":171,"lon":170},{"facility":174,"status":73,"city":175,"state":176,"zip":177,"country":77,"countryCode":78,"cosmosGeoPoint":178,"geoPoint":182,"contacts":49},"Swedish Medical Center","Seattle","Washington","98104",{"type":80,"coordinates":179},[180,181],-122.33207,47.60621,{"lat":181,"lon":180},{"facility":184,"status":73,"city":185,"state":49,"zip":186,"country":187,"countryCode":188,"cosmosGeoPoint":189,"geoPoint":193,"contacts":49},"Institut Bergonie","Bordeaux","33000","France","FR",{"type":80,"coordinates":190},[191,192],-0.58046,44.84124,{"lat":192,"lon":191},{"facility":195,"status":73,"city":196,"state":49,"zip":197,"country":187,"countryCode":188,"cosmosGeoPoint":198,"geoPoint":202,"contacts":49},"Centre Leon Berard","Lyon","69008",{"type":80,"coordinates":199},[200,201],4.84789,45.74906,{"lat":201,"lon":200},{"facility":204,"status":73,"city":205,"state":49,"zip":206,"country":187,"countryCode":188,"cosmosGeoPoint":207,"geoPoint":211,"contacts":49},"Institut Gustave Roussy","Villejuif","94800",{"type":80,"coordinates":208},[209,210],2.35992,48.7939,{"lat":210,"lon":209},{"facility":213,"status":73,"city":214,"state":49,"zip":215,"country":216,"countryCode":217,"cosmosGeoPoint":218,"geoPoint":222,"contacts":49},"The Cancer Institute Hospital of JFCR","Tokyo","135 8550","Japan","JP",{"type":80,"coordinates":219},[220,221],139.69171,35.6895,{"lat":221,"lon":220},{"type":224,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100523392","phase-1-a-study-of-jnj-87189401-combined-with-jnj-78278343-for-advanced-prostate-cancer-100523392",false,"NCT06095089","A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer","A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed\n* Measurable or evaluable disease per PCWG3 criteria\n* Part 1, Parts 2A, 2B, 3 and 4: Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist), prior to the first dose of study drug and must continue this therapy throughout the treatment phase\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\nExclusion Criteria:\n\n* History of an autoimmune disease within the 12 months prior to signing consent\n* Any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clinically significant ventricular arrhythmias, d. congestive heart failure (New York Heart Association \\[NYHA\\] class II to IV), e. transient ischemic attack, and f. Cerebrovascular accident","MALE","18 Years",{"count":235,"type":236},355,"ESTIMATED","INTERVENTIONAL",[239],"PHASE1","The purpose of Parts 1, 2A, and 2B of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 and the purpose of Part 2C of this study is to determine how safe the RP2R(s) of the combination of JNJ-87189401 and JNJ-78278343 is, with or without apalutamide. Part 3 of this study evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with standard of care (SOC) lutetium Lu-177 vipivotide tetraxetan. Part 4 of this study further evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with JNJ-101556143 in participants with advanced prostate cancer.",[242],"Prostatic Neoplasms","2026-06-04",{"date":245,"type":246},"2026-06-05","ACTUAL",{"date":248,"type":246},"2023-11-01",{"date":250,"type":236},"2028-06-28",{"name":5,"class":6},15]