[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100479166":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":39,"centralContacts":43,"locations":48,"responsibleParty":381,"collaborators":33,"id":383,"slug":33,"hasResults":384,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":33,"eligibilityCriteria":388,"healthyVolunteers":384,"sex":389,"minAge":390,"maxAge":391,"enrollmentInfo":392,"targetDuration":33,"studyType":395,"phases":396,"briefSummary":398,"conditions":399,"keywords":403,"overallStatus":51,"whyStopped":33,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":414},{"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",[49,62,72,82,88,97,106,118,128,137,147,157,168,178,186,196,206,214,219,228,238,248,258,267,276,286,296,306,316,322,331,341,350,361,371],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":33},"University of Alabama at Birmingham Hospital","RECRUITING","Birmingham","Alabama","35249","United States",{"type":57,"coordinates":58},"Point",[59,60],-86.80249,33.52066,{"lat":60,"lon":59},{"facility":63,"status":51,"city":64,"state":65,"zip":66,"country":55,"cosmosGeoPoint":67,"geoPoint":71,"contacts":33},"Mayo Clinic","Phoenix","Arizona","85054",{"type":57,"coordinates":68},[69,70],-112.07404,33.44838,{"lat":70,"lon":69},{"facility":73,"status":51,"city":74,"state":75,"zip":76,"country":55,"cosmosGeoPoint":77,"geoPoint":81,"contacts":33},"USC Norris Comprehensive Cancer Center","Los Angeles","California","90033",{"type":57,"coordinates":78},[79,80],-118.24368,34.05223,{"lat":80,"lon":79},{"facility":83,"status":51,"city":74,"state":75,"zip":84,"country":55,"cosmosGeoPoint":85,"geoPoint":87,"contacts":33},"UCLA Department of Medicine","90095",{"type":57,"coordinates":86},[79,80],{"lat":80,"lon":79},{"facility":89,"status":51,"city":90,"state":75,"zip":91,"country":55,"cosmosGeoPoint":92,"geoPoint":96,"contacts":33},"Hoag Memorial Hospital Presbyterian","Newport Beach","92663",{"type":57,"coordinates":93},[94,95],-117.92895,33.61891,{"lat":95,"lon":94},{"facility":98,"status":51,"city":99,"state":75,"zip":100,"country":55,"cosmosGeoPoint":101,"geoPoint":105,"contacts":33},"University of California Davis Comprehensive Cancer Center","Sacramento","95817",{"type":57,"coordinates":102},[103,104],-121.4944,38.58157,{"lat":104,"lon":103},{"facility":107,"status":51,"city":108,"state":75,"zip":109,"country":55,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"UCSF Helen Diller Family Comprehensive Cancer Center","San Francisco","94158",{"type":57,"coordinates":111},[112,113],-122.41942,37.77493,{"lat":113,"lon":112},[116],{"name":33,"role":45,"phone":33,"phoneExt":33,"email":117},"HDFCCC.CIP@ucsf.edu",{"facility":119,"status":51,"city":120,"state":121,"zip":122,"country":55,"cosmosGeoPoint":123,"geoPoint":127,"contacts":33},"Yale New Haven Hospital","New Haven","Connecticut","06510",{"type":57,"coordinates":124},[125,126],-72.92816,41.30815,{"lat":126,"lon":125},{"facility":63,"status":51,"city":129,"state":130,"zip":131,"country":55,"cosmosGeoPoint":132,"geoPoint":136,"contacts":33},"Jacksonville","Florida","32224",{"type":57,"coordinates":133},[134,135],-81.65565,30.33218,{"lat":135,"lon":134},{"facility":138,"status":51,"city":139,"state":140,"zip":141,"country":55,"cosmosGeoPoint":142,"geoPoint":146,"contacts":33},"University of Chicago Medical Center","Chicago","Illinois","60637",{"type":57,"coordinates":143},[144,145],-87.65005,41.85003,{"lat":145,"lon":144},{"facility":148,"status":51,"city":149,"state":150,"zip":151,"country":55,"cosmosGeoPoint":152,"geoPoint":156,"contacts":33},"University of Maryland Greenebaum Comprehensive Cancer Center","Baltimore","Maryland","21201",{"type":57,"coordinates":153},[154,155],-76.61219,39.29038,{"lat":155,"lon":154},{"facility":158,"status":159,"city":160,"state":161,"zip":162,"country":55,"cosmosGeoPoint":163,"geoPoint":167,"contacts":33},"Massachusetts General Hospital","ACTIVE_NOT_RECRUITING","Boston","Massachusetts","02114",{"type":57,"coordinates":164},[165,166],-71.05977,42.35843,{"lat":166,"lon":165},{"facility":169,"status":51,"city":170,"state":171,"zip":172,"country":55,"cosmosGeoPoint":173,"geoPoint":177,"contacts":33},"University of Minnesota Medical Center","Minneapolis","Minnesota","55455",{"type":57,"coordinates":174},[175,176],-93.26384,44.97997,{"lat":176,"lon":175},{"facility":63,"status":51,"city":179,"state":171,"zip":180,"country":55,"cosmosGeoPoint":181,"geoPoint":185,"contacts":33},"Rochester","55905",{"type":57,"coordinates":182},[183,184],-92.4699,44.02163,{"lat":184,"lon":183},{"facility":187,"status":51,"city":188,"state":189,"zip":190,"country":55,"cosmosGeoPoint":191,"geoPoint":195,"contacts":33},"Washington University School of Medicine","St Louis","Missouri","63110",{"type":57,"coordinates":192},[193,194],-90.19789,38.62727,{"lat":194,"lon":193},{"facility":197,"status":51,"city":198,"state":199,"zip":200,"country":55,"cosmosGeoPoint":201,"geoPoint":205,"contacts":33},"Northwell Health R.J. Zuckerberg Cancer Hospital","Lake Success","New York","11042",{"type":57,"coordinates":202},[203,204],-73.71763,40.77066,{"lat":204,"lon":203},{"facility":207,"status":51,"city":199,"state":199,"zip":208,"country":55,"cosmosGeoPoint":209,"geoPoint":213,"contacts":33},"Memorial Sloan Kettering Cancer Center","10065",{"type":57,"coordinates":210},[211,212],-74.00597,40.71427,{"lat":212,"lon":211},{"facility":215,"status":51,"city":199,"state":199,"zip":208,"country":55,"cosmosGeoPoint":216,"geoPoint":218,"contacts":33},"Weill Cornell Medicine",{"type":57,"coordinates":217},[211,212],{"lat":212,"lon":211},{"facility":220,"status":51,"city":221,"state":199,"zip":222,"country":55,"cosmosGeoPoint":223,"geoPoint":227,"contacts":33},"Montefiore Medical Center","The Bronx","10461",{"type":57,"coordinates":224},[225,226],-73.86641,40.84985,{"lat":226,"lon":225},{"facility":229,"status":51,"city":230,"state":231,"zip":232,"country":55,"cosmosGeoPoint":233,"geoPoint":237,"contacts":33},"University of Cincinnati Medical Center","Cincinnati","Ohio","45267",{"type":57,"coordinates":234},[235,236],-84.51439,39.12711,{"lat":236,"lon":235},{"facility":239,"status":159,"city":240,"state":241,"zip":242,"country":55,"cosmosGeoPoint":243,"geoPoint":247,"contacts":33},"Oregon Health and Science University","Portland","Oregon","97239",{"type":57,"coordinates":244},[245,246],-122.67621,45.52345,{"lat":246,"lon":245},{"facility":249,"status":51,"city":250,"state":251,"zip":252,"country":55,"cosmosGeoPoint":253,"geoPoint":257,"contacts":33},"Penn State Milton S. Hershey Medical Center","Hershey","Pennsylvania","17033",{"type":57,"coordinates":254},[255,256],-76.65025,40.28592,{"lat":256,"lon":255},{"facility":259,"status":51,"city":260,"state":251,"zip":261,"country":55,"cosmosGeoPoint":262,"geoPoint":266,"contacts":33},"Thomas Jefferson University Honickman Center","Philadelphia","19107",{"type":57,"coordinates":263},[264,265],-75.16362,39.95238,{"lat":265,"lon":264},{"facility":268,"status":51,"city":269,"state":251,"zip":270,"country":55,"cosmosGeoPoint":271,"geoPoint":275,"contacts":33},"UPMC Hillman Cancer Center","Pittsburgh","15232",{"type":57,"coordinates":272},[273,274],-79.99589,40.44062,{"lat":274,"lon":273},{"facility":277,"status":51,"city":278,"state":279,"zip":280,"country":55,"cosmosGeoPoint":281,"geoPoint":285,"contacts":33},"Rhode Island Hospital","Providence","Rhode Island","02903",{"type":57,"coordinates":282},[283,284],-71.41283,41.82399,{"lat":284,"lon":283},{"facility":287,"status":51,"city":288,"state":289,"zip":290,"country":55,"cosmosGeoPoint":291,"geoPoint":295,"contacts":33},"Medical University of South Carolina","Charleston","South Carolina","29425",{"type":57,"coordinates":292},[293,294],-79.93275,32.77632,{"lat":294,"lon":293},{"facility":297,"status":51,"city":298,"state":299,"zip":300,"country":55,"cosmosGeoPoint":301,"geoPoint":305,"contacts":33},"Sarah Cannon Research","Nashville","Tennessee","37203",{"type":57,"coordinates":302},[303,304],-86.78444,36.16589,{"lat":304,"lon":303},{"facility":307,"status":51,"city":308,"state":309,"zip":310,"country":55,"cosmosGeoPoint":311,"geoPoint":315,"contacts":33},"Mary Crowley Cancer Research","Dallas","Texas","75230",{"type":57,"coordinates":312},[313,314],-96.80667,32.78306,{"lat":314,"lon":313},{"facility":317,"status":51,"city":308,"state":309,"zip":318,"country":55,"cosmosGeoPoint":319,"geoPoint":321,"contacts":33},"University of Texas Southwestern Medical Center","75390",{"type":57,"coordinates":320},[313,314],{"lat":314,"lon":313},{"facility":323,"status":51,"city":324,"state":309,"zip":325,"country":55,"cosmosGeoPoint":326,"geoPoint":330,"contacts":33},"Houston Methodist Hospital","Houston","77030",{"type":57,"coordinates":327},[328,329],-95.36327,29.76328,{"lat":329,"lon":328},{"facility":332,"status":51,"city":333,"state":334,"zip":335,"country":55,"cosmosGeoPoint":336,"geoPoint":340,"contacts":33},"University of Wisconsin Carbone Cancer Center","Madison","Wisconsin","53792",{"type":57,"coordinates":337},[338,339],-89.40123,43.07305,{"lat":339,"lon":338},{"facility":342,"status":51,"city":343,"state":334,"zip":344,"country":55,"cosmosGeoPoint":345,"geoPoint":349,"contacts":33},"Froedtert Hospital and the Medical College of Wisconsin","Milwaukee","53226",{"type":57,"coordinates":346},[347,348],-87.90647,43.0389,{"lat":348,"lon":347},{"facility":351,"status":51,"city":352,"state":353,"zip":354,"country":355,"cosmosGeoPoint":356,"geoPoint":360,"contacts":33},"Chris O'Brien Lifehouse (COBLH)","Camperdown","New South Wales","2050","Australia",{"type":57,"coordinates":357},[358,359],151.17642,-33.88965,{"lat":359,"lon":358},{"facility":362,"status":51,"city":363,"state":364,"zip":365,"country":355,"cosmosGeoPoint":366,"geoPoint":370,"contacts":33},"Southern Oncology Clinical Research Unit (SoCRU)","Bedford Park","South Australia","5042",{"type":57,"coordinates":367},[368,369],138.56815,-35.02204,{"lat":369,"lon":368},{"facility":372,"status":51,"city":373,"state":374,"zip":375,"country":355,"cosmosGeoPoint":376,"geoPoint":380,"contacts":33},"Linear Clinical Research Ltd.","Nedlands","Western Australia","6009",{"type":57,"coordinates":377},[378,379],115.8073,-31.98184,{"lat":379,"lon":378},{"type":382,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","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":393,"type":394},272,"ESTIMATED","INTERVENTIONAL",[397],"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).",[400,401,402],"Prostate Cancer","Metastatic Castration-resistant Prostate Cancer","Castration Resistant Prostatic Cancer",[400,404],"Castration-resistant prostate cancer","2026-01-15",{"date":407,"type":408},"2026-01-20","ACTUAL",{"date":410,"type":408},"2022-09-15",{"date":412,"type":394},"2028-12",{"name":5,"class":6},35]