[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100479166":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":39,"centralContacts":43,"locations":48,"responsibleParty":386,"collaborators":33,"id":388,"slug":389,"hasResults":390,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":33,"eligibilityCriteria":394,"healthyVolunteers":390,"sex":395,"minAge":396,"maxAge":397,"enrollmentInfo":398,"targetDuration":33,"studyType":401,"phases":402,"briefSummary":404,"conditions":405,"keywords":409,"overallStatus":51,"whyStopped":33,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":420},{"fullName":5,"class":6},"Janux Therapeutics","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation","EXPERIMENTAL","IV dosing during 21- or 28-day cycles. Dosage per cohort will increase to determine the maximum tolerable dose.",[13],"Biological: JANX007",{"label":15,"type":10,"description":16,"interventionNames":17},"Backfill Expansion","IV dosing during 21- or 28-day cycles. Subjects will be dosed at levels previously declared tolerable.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Monotherapy Expansion Parts A - D","IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose (RP2D).",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Combination Expansion","IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose",[13,26],"Drug: Darolutamide",[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"BIOLOGICAL","JANX007","JANX007 is dosed via IV in a 21- or 28-day cycle.",[15,23,9,19],null,{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":33},"DRUG","Darolutamide","Darolutamide is dosed via oral tablets",[23],[40],{"name":41,"affiliation":5,"role":42},"Janux Therapeutics, MD","STUDY_DIRECTOR",[44],{"name":5,"role":45,"phone":46,"phoneExt":33,"email":47},"CONTACT","858-206-8471","psma-007-001_ct.gov@januxrx.com",[49,63,73,83,89,98,107,119,129,138,148,158,168,176,186,196,205,213,219,224,233,243,252,262,271,280,290,300,310,320,326,335,345,354,366,376],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":33},"University of Alabama at Birmingham Hospital","RECRUITING","Birmingham","Alabama","35249","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-86.80249,33.52066,{"lat":61,"lon":60},{"facility":64,"status":51,"city":65,"state":66,"zip":67,"country":55,"countryCode":56,"cosmosGeoPoint":68,"geoPoint":72,"contacts":33},"Mayo Clinic","Phoenix","Arizona","85054",{"type":58,"coordinates":69},[70,71],-112.07404,33.44838,{"lat":71,"lon":70},{"facility":74,"status":51,"city":75,"state":76,"zip":77,"country":55,"countryCode":56,"cosmosGeoPoint":78,"geoPoint":82,"contacts":33},"USC Norris Comprehensive Cancer Center","Los Angeles","California","90033",{"type":58,"coordinates":79},[80,81],-118.24368,34.05223,{"lat":81,"lon":80},{"facility":84,"status":51,"city":75,"state":76,"zip":85,"country":55,"countryCode":56,"cosmosGeoPoint":86,"geoPoint":88,"contacts":33},"UCLA Department of Medicine","90095",{"type":58,"coordinates":87},[80,81],{"lat":81,"lon":80},{"facility":90,"status":51,"city":91,"state":76,"zip":92,"country":55,"countryCode":56,"cosmosGeoPoint":93,"geoPoint":97,"contacts":33},"Hoag Memorial Hospital Presbyterian","Newport Beach","92663",{"type":58,"coordinates":94},[95,96],-117.92895,33.61891,{"lat":96,"lon":95},{"facility":99,"status":51,"city":100,"state":76,"zip":101,"country":55,"countryCode":56,"cosmosGeoPoint":102,"geoPoint":106,"contacts":33},"University of California Davis Comprehensive Cancer Center","Sacramento","95817",{"type":58,"coordinates":103},[104,105],-121.4944,38.58157,{"lat":105,"lon":104},{"facility":108,"status":51,"city":109,"state":76,"zip":110,"country":55,"countryCode":56,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"UCSF Helen Diller Family Comprehensive Cancer Center","San Francisco","94158",{"type":58,"coordinates":112},[113,114],-122.41942,37.77493,{"lat":114,"lon":113},[117],{"name":33,"role":45,"phone":33,"phoneExt":33,"email":118},"HDFCCC.CIP@ucsf.edu",{"facility":120,"status":51,"city":121,"state":122,"zip":123,"country":55,"countryCode":56,"cosmosGeoPoint":124,"geoPoint":128,"contacts":33},"Yale New Haven Hospital","New Haven","Connecticut","06510",{"type":58,"coordinates":125},[126,127],-72.92816,41.30815,{"lat":127,"lon":126},{"facility":64,"status":51,"city":130,"state":131,"zip":132,"country":55,"countryCode":56,"cosmosGeoPoint":133,"geoPoint":137,"contacts":33},"Jacksonville","Florida","32224",{"type":58,"coordinates":134},[135,136],-81.65565,30.33218,{"lat":136,"lon":135},{"facility":139,"status":51,"city":140,"state":141,"zip":142,"country":55,"countryCode":56,"cosmosGeoPoint":143,"geoPoint":147,"contacts":33},"University of Chicago Medical Center","Chicago","Illinois","60637",{"type":58,"coordinates":144},[145,146],-87.65005,41.85003,{"lat":146,"lon":145},{"facility":149,"status":51,"city":150,"state":151,"zip":152,"country":55,"countryCode":56,"cosmosGeoPoint":153,"geoPoint":157,"contacts":33},"University of Maryland Greenebaum Comprehensive Cancer Center","Baltimore","Maryland","21201",{"type":58,"coordinates":154},[155,156],-76.61219,39.29038,{"lat":156,"lon":155},{"facility":159,"status":51,"city":160,"state":161,"zip":162,"country":55,"countryCode":56,"cosmosGeoPoint":163,"geoPoint":167,"contacts":33},"University of Minnesota Medical Center","Minneapolis","Minnesota","55455",{"type":58,"coordinates":164},[165,166],-93.26384,44.97997,{"lat":166,"lon":165},{"facility":64,"status":51,"city":169,"state":161,"zip":170,"country":55,"countryCode":56,"cosmosGeoPoint":171,"geoPoint":175,"contacts":33},"Rochester","55905",{"type":58,"coordinates":172},[173,174],-92.4699,44.02163,{"lat":174,"lon":173},{"facility":177,"status":51,"city":178,"state":179,"zip":180,"country":55,"countryCode":56,"cosmosGeoPoint":181,"geoPoint":185,"contacts":33},"Washington University School of Medicine","St Louis","Missouri","63110",{"type":58,"coordinates":182},[183,184],-90.19789,38.62727,{"lat":184,"lon":183},{"facility":187,"status":51,"city":188,"state":189,"zip":190,"country":55,"countryCode":56,"cosmosGeoPoint":191,"geoPoint":195,"contacts":33},"Northwell Health R.J. Zuckerberg Cancer Hospital","Lake Success","New York","11042",{"type":58,"coordinates":192},[193,194],-73.71763,40.77066,{"lat":194,"lon":193},{"facility":197,"status":51,"city":198,"state":189,"zip":199,"country":55,"countryCode":56,"cosmosGeoPoint":200,"geoPoint":204,"contacts":33},"NYU Langone Health Long Island","Mineola","11501",{"type":58,"coordinates":201},[202,203],-73.64068,40.74927,{"lat":203,"lon":202},{"facility":206,"status":51,"city":189,"state":189,"zip":207,"country":55,"countryCode":56,"cosmosGeoPoint":208,"geoPoint":212,"contacts":33},"NYU Langone Health","10016",{"type":58,"coordinates":209},[210,211],-74.00597,40.71427,{"lat":211,"lon":210},{"facility":214,"status":51,"city":189,"state":189,"zip":215,"country":55,"countryCode":56,"cosmosGeoPoint":216,"geoPoint":218,"contacts":33},"Memorial Sloan Kettering Cancer Center","10065",{"type":58,"coordinates":217},[210,211],{"lat":211,"lon":210},{"facility":220,"status":51,"city":189,"state":189,"zip":215,"country":55,"countryCode":56,"cosmosGeoPoint":221,"geoPoint":223,"contacts":33},"Weill Cornell Medicine",{"type":58,"coordinates":222},[210,211],{"lat":211,"lon":210},{"facility":225,"status":51,"city":226,"state":189,"zip":227,"country":55,"countryCode":56,"cosmosGeoPoint":228,"geoPoint":232,"contacts":33},"Montefiore Medical Center","The Bronx","10461",{"type":58,"coordinates":229},[230,231],-73.86641,40.84985,{"lat":231,"lon":230},{"facility":234,"status":51,"city":235,"state":236,"zip":237,"country":55,"countryCode":56,"cosmosGeoPoint":238,"geoPoint":242,"contacts":33},"University of Cincinnati Medical Center","Cincinnati","Ohio","45267",{"type":58,"coordinates":239},[240,241],-84.51439,39.12711,{"lat":241,"lon":240},{"facility":244,"status":51,"city":245,"state":236,"zip":246,"country":55,"countryCode":56,"cosmosGeoPoint":247,"geoPoint":251,"contacts":33},"The Ohio State University","Columbus","43221",{"type":58,"coordinates":248},[249,250],-82.99879,39.96118,{"lat":250,"lon":249},{"facility":253,"status":51,"city":254,"state":255,"zip":256,"country":55,"countryCode":56,"cosmosGeoPoint":257,"geoPoint":261,"contacts":33},"Penn State Milton S. Hershey Medical Center","Hershey","Pennsylvania","17033",{"type":58,"coordinates":258},[259,260],-76.65025,40.28592,{"lat":260,"lon":259},{"facility":263,"status":51,"city":264,"state":255,"zip":265,"country":55,"countryCode":56,"cosmosGeoPoint":266,"geoPoint":270,"contacts":33},"Thomas Jefferson University Honickman Center","Philadelphia","19107",{"type":58,"coordinates":267},[268,269],-75.16362,39.95238,{"lat":269,"lon":268},{"facility":272,"status":51,"city":273,"state":255,"zip":274,"country":55,"countryCode":56,"cosmosGeoPoint":275,"geoPoint":279,"contacts":33},"UPMC Hillman Cancer Center","Pittsburgh","15232",{"type":58,"coordinates":276},[277,278],-79.99589,40.44062,{"lat":278,"lon":277},{"facility":281,"status":51,"city":282,"state":283,"zip":284,"country":55,"countryCode":56,"cosmosGeoPoint":285,"geoPoint":289,"contacts":33},"Rhode Island Hospital","Providence","Rhode Island","02903",{"type":58,"coordinates":286},[287,288],-71.41283,41.82399,{"lat":288,"lon":287},{"facility":291,"status":51,"city":292,"state":293,"zip":294,"country":55,"countryCode":56,"cosmosGeoPoint":295,"geoPoint":299,"contacts":33},"Medical University of South Carolina","Charleston","South Carolina","29425",{"type":58,"coordinates":296},[297,298],-79.93275,32.77632,{"lat":298,"lon":297},{"facility":301,"status":51,"city":302,"state":303,"zip":304,"country":55,"countryCode":56,"cosmosGeoPoint":305,"geoPoint":309,"contacts":33},"Sarah Cannon Research","Nashville","Tennessee","37203",{"type":58,"coordinates":306},[307,308],-86.78444,36.16589,{"lat":308,"lon":307},{"facility":311,"status":51,"city":312,"state":313,"zip":314,"country":55,"countryCode":56,"cosmosGeoPoint":315,"geoPoint":319,"contacts":33},"Mary Crowley Cancer Research","Dallas","Texas","75230",{"type":58,"coordinates":316},[317,318],-96.80667,32.78306,{"lat":318,"lon":317},{"facility":321,"status":51,"city":312,"state":313,"zip":322,"country":55,"countryCode":56,"cosmosGeoPoint":323,"geoPoint":325,"contacts":33},"University of Texas Southwestern Medical Center","75390",{"type":58,"coordinates":324},[317,318],{"lat":318,"lon":317},{"facility":327,"status":51,"city":328,"state":313,"zip":329,"country":55,"countryCode":56,"cosmosGeoPoint":330,"geoPoint":334,"contacts":33},"Houston Methodist Hospital","Houston","77030",{"type":58,"coordinates":331},[332,333],-95.36327,29.76328,{"lat":333,"lon":332},{"facility":336,"status":51,"city":337,"state":338,"zip":339,"country":55,"countryCode":56,"cosmosGeoPoint":340,"geoPoint":344,"contacts":33},"University of Wisconsin Carbone Cancer Center","Madison","Wisconsin","53792",{"type":58,"coordinates":341},[342,343],-89.40123,43.07305,{"lat":343,"lon":342},{"facility":346,"status":51,"city":347,"state":338,"zip":348,"country":55,"countryCode":56,"cosmosGeoPoint":349,"geoPoint":353,"contacts":33},"Froedtert Hospital and the Medical College of Wisconsin","Milwaukee","53226",{"type":58,"coordinates":350},[351,352],-87.90647,43.0389,{"lat":352,"lon":351},{"facility":355,"status":51,"city":356,"state":357,"zip":358,"country":359,"countryCode":360,"cosmosGeoPoint":361,"geoPoint":365,"contacts":33},"Chris O'Brien Lifehouse (COBLH)","Camperdown","New South Wales","2050","Australia","AU",{"type":58,"coordinates":362},[363,364],151.17642,-33.88965,{"lat":364,"lon":363},{"facility":367,"status":51,"city":368,"state":369,"zip":370,"country":359,"countryCode":360,"cosmosGeoPoint":371,"geoPoint":375,"contacts":33},"Southern Oncology Clinical Research Unit (SoCRU)","Bedford Park","South Australia","5042",{"type":58,"coordinates":372},[373,374],138.56815,-35.02204,{"lat":374,"lon":373},{"facility":377,"status":51,"city":378,"state":379,"zip":380,"country":359,"countryCode":360,"cosmosGeoPoint":381,"geoPoint":385,"contacts":33},"Linear Clinical Research Ltd.","Nedlands","Western Australia","6009",{"type":58,"coordinates":382},[383,384],115.8073,-31.98184,{"lat":384,"lon":383},{"type":387,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100479166","phase-1-study-of-janx007-in-subjects-with-metastatic-castration-resistant-prostate-cancer-engager-psma-01-100479166",false,"NCT05519449","Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)","A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n* Male ≥18 years of age at the time of signing informed consent\n* Histologically or cytologically confirmed adenocarcinoma of the prostate\n* For Dose Escalation and Backfill: Having mCRPC that progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen. Participants who have actively refused a taxane containing regimen or are medically unsuitable to receive taxane are eligible\n* Adequate organ function\n* For Monotherapy Expansion Part a: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1 prior taxane regimen in the HSPC or CRPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.\n* For Monotherapy Expansion Part b: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC settings\n* For Monotherapy Expansion Part d: Have received ≤ 1 anti-androgen therapy and a poly(ADP-ribose) polymerase (PARP) inhibitor for mCRPC and have progressed following treatment with the PARP inhibitor\n* For Combination Expansion: Have received ≤ 1 anti-androgen therapy other than darolutamide in the HSPC setting and ≤ 1 taxane in the mCRPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.\n\nExclusion Criteria:\n\n* Prior solid organ transplant\n* Prior treatment with PSMA-targeted CAR-T cell therapy or PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies or radioligand therapy\n* Clinically significant cardiovascular disease\n* For Monotherapy Expansion Part a: Prior receipt of any treatment other than an ARPI or taxane in the mCRPC setting\n* For Monotherapy Expansion Part b: Prior receipt of any treatment other than an anti-androgen therapy or prior receipt of a taxane containing regimen or more than 1 prior line of therapy for mCRPC\n* For Monotherapy Part d: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than an anti-androgen therapy and PARP inhibitor for mCRPC or prior receipt of a taxane in the mCRPC setting\n* For Combination expansion: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than a taxane for mCRPC or prior receipt of Darolutamide or prior receipt of a taxane for HSPC\n* Active clinically significant infection (bacterial, viral, fungal, mycobacteria or other)\n* Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment","MALE","18 Years","100 Years",{"count":399,"type":400},272,"ESTIMATED","INTERVENTIONAL",[403],"PHASE1","This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).",[406,407,408],"Prostate Cancer","Metastatic Castration-resistant Prostate Cancer","Castration Resistant Prostatic Cancer",[406,410],"Castration-resistant prostate cancer","2026-08-11",{"date":413,"type":414},"2026-08-13","ACTUAL",{"date":416,"type":414},"2022-09-15",{"date":418,"type":400},"2028-12",{"name":5,"class":6},36]