[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100479166":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":39,"centralContacts":43,"locations":48,"responsibleParty":383,"collaborators":33,"id":385,"slug":386,"hasResults":387,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":33,"eligibilityCriteria":391,"healthyVolunteers":387,"sex":392,"minAge":393,"maxAge":394,"enrollmentInfo":395,"targetDuration":33,"studyType":398,"phases":399,"briefSummary":401,"conditions":402,"keywords":406,"overallStatus":51,"whyStopped":33,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":417},{"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",[49,63,73,83,89,98,107,119,129,138,148,158,169,179,187,197,207,215,220,229,239,249,259,268,277,287,297,307,317,323,332,342,351,363,373],{"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":160,"city":161,"state":162,"zip":163,"country":55,"countryCode":56,"cosmosGeoPoint":164,"geoPoint":168,"contacts":33},"Massachusetts General Hospital","ACTIVE_NOT_RECRUITING","Boston","Massachusetts","02114",{"type":58,"coordinates":165},[166,167],-71.05977,42.35843,{"lat":167,"lon":166},{"facility":170,"status":51,"city":171,"state":172,"zip":173,"country":55,"countryCode":56,"cosmosGeoPoint":174,"geoPoint":178,"contacts":33},"University of Minnesota Medical Center","Minneapolis","Minnesota","55455",{"type":58,"coordinates":175},[176,177],-93.26384,44.97997,{"lat":177,"lon":176},{"facility":64,"status":51,"city":180,"state":172,"zip":181,"country":55,"countryCode":56,"cosmosGeoPoint":182,"geoPoint":186,"contacts":33},"Rochester","55905",{"type":58,"coordinates":183},[184,185],-92.4699,44.02163,{"lat":185,"lon":184},{"facility":188,"status":51,"city":189,"state":190,"zip":191,"country":55,"countryCode":56,"cosmosGeoPoint":192,"geoPoint":196,"contacts":33},"Washington University School of Medicine","St Louis","Missouri","63110",{"type":58,"coordinates":193},[194,195],-90.19789,38.62727,{"lat":195,"lon":194},{"facility":198,"status":51,"city":199,"state":200,"zip":201,"country":55,"countryCode":56,"cosmosGeoPoint":202,"geoPoint":206,"contacts":33},"Northwell Health R.J. Zuckerberg Cancer Hospital","Lake Success","New York","11042",{"type":58,"coordinates":203},[204,205],-73.71763,40.77066,{"lat":205,"lon":204},{"facility":208,"status":51,"city":200,"state":200,"zip":209,"country":55,"countryCode":56,"cosmosGeoPoint":210,"geoPoint":214,"contacts":33},"Memorial Sloan Kettering Cancer Center","10065",{"type":58,"coordinates":211},[212,213],-74.00597,40.71427,{"lat":213,"lon":212},{"facility":216,"status":51,"city":200,"state":200,"zip":209,"country":55,"countryCode":56,"cosmosGeoPoint":217,"geoPoint":219,"contacts":33},"Weill Cornell Medicine",{"type":58,"coordinates":218},[212,213],{"lat":213,"lon":212},{"facility":221,"status":51,"city":222,"state":200,"zip":223,"country":55,"countryCode":56,"cosmosGeoPoint":224,"geoPoint":228,"contacts":33},"Montefiore Medical Center","The Bronx","10461",{"type":58,"coordinates":225},[226,227],-73.86641,40.84985,{"lat":227,"lon":226},{"facility":230,"status":51,"city":231,"state":232,"zip":233,"country":55,"countryCode":56,"cosmosGeoPoint":234,"geoPoint":238,"contacts":33},"University of Cincinnati Medical Center","Cincinnati","Ohio","45267",{"type":58,"coordinates":235},[236,237],-84.51439,39.12711,{"lat":237,"lon":236},{"facility":240,"status":160,"city":241,"state":242,"zip":243,"country":55,"countryCode":56,"cosmosGeoPoint":244,"geoPoint":248,"contacts":33},"Oregon Health and Science University","Portland","Oregon","97239",{"type":58,"coordinates":245},[246,247],-122.67621,45.52345,{"lat":247,"lon":246},{"facility":250,"status":51,"city":251,"state":252,"zip":253,"country":55,"countryCode":56,"cosmosGeoPoint":254,"geoPoint":258,"contacts":33},"Penn State Milton S. Hershey Medical Center","Hershey","Pennsylvania","17033",{"type":58,"coordinates":255},[256,257],-76.65025,40.28592,{"lat":257,"lon":256},{"facility":260,"status":51,"city":261,"state":252,"zip":262,"country":55,"countryCode":56,"cosmosGeoPoint":263,"geoPoint":267,"contacts":33},"Thomas Jefferson University Honickman Center","Philadelphia","19107",{"type":58,"coordinates":264},[265,266],-75.16362,39.95238,{"lat":266,"lon":265},{"facility":269,"status":51,"city":270,"state":252,"zip":271,"country":55,"countryCode":56,"cosmosGeoPoint":272,"geoPoint":276,"contacts":33},"UPMC Hillman Cancer Center","Pittsburgh","15232",{"type":58,"coordinates":273},[274,275],-79.99589,40.44062,{"lat":275,"lon":274},{"facility":278,"status":51,"city":279,"state":280,"zip":281,"country":55,"countryCode":56,"cosmosGeoPoint":282,"geoPoint":286,"contacts":33},"Rhode Island Hospital","Providence","Rhode Island","02903",{"type":58,"coordinates":283},[284,285],-71.41283,41.82399,{"lat":285,"lon":284},{"facility":288,"status":51,"city":289,"state":290,"zip":291,"country":55,"countryCode":56,"cosmosGeoPoint":292,"geoPoint":296,"contacts":33},"Medical University of South Carolina","Charleston","South Carolina","29425",{"type":58,"coordinates":293},[294,295],-79.93275,32.77632,{"lat":295,"lon":294},{"facility":298,"status":51,"city":299,"state":300,"zip":301,"country":55,"countryCode":56,"cosmosGeoPoint":302,"geoPoint":306,"contacts":33},"Sarah Cannon Research","Nashville","Tennessee","37203",{"type":58,"coordinates":303},[304,305],-86.78444,36.16589,{"lat":305,"lon":304},{"facility":308,"status":51,"city":309,"state":310,"zip":311,"country":55,"countryCode":56,"cosmosGeoPoint":312,"geoPoint":316,"contacts":33},"Mary Crowley Cancer Research","Dallas","Texas","75230",{"type":58,"coordinates":313},[314,315],-96.80667,32.78306,{"lat":315,"lon":314},{"facility":318,"status":51,"city":309,"state":310,"zip":319,"country":55,"countryCode":56,"cosmosGeoPoint":320,"geoPoint":322,"contacts":33},"University of Texas Southwestern Medical Center","75390",{"type":58,"coordinates":321},[314,315],{"lat":315,"lon":314},{"facility":324,"status":51,"city":325,"state":310,"zip":326,"country":55,"countryCode":56,"cosmosGeoPoint":327,"geoPoint":331,"contacts":33},"Houston Methodist Hospital","Houston","77030",{"type":58,"coordinates":328},[329,330],-95.36327,29.76328,{"lat":330,"lon":329},{"facility":333,"status":51,"city":334,"state":335,"zip":336,"country":55,"countryCode":56,"cosmosGeoPoint":337,"geoPoint":341,"contacts":33},"University of Wisconsin Carbone Cancer Center","Madison","Wisconsin","53792",{"type":58,"coordinates":338},[339,340],-89.40123,43.07305,{"lat":340,"lon":339},{"facility":343,"status":51,"city":344,"state":335,"zip":345,"country":55,"countryCode":56,"cosmosGeoPoint":346,"geoPoint":350,"contacts":33},"Froedtert Hospital and the Medical College of Wisconsin","Milwaukee","53226",{"type":58,"coordinates":347},[348,349],-87.90647,43.0389,{"lat":349,"lon":348},{"facility":352,"status":51,"city":353,"state":354,"zip":355,"country":356,"countryCode":357,"cosmosGeoPoint":358,"geoPoint":362,"contacts":33},"Chris O'Brien Lifehouse (COBLH)","Camperdown","New South Wales","2050","Australia","AU",{"type":58,"coordinates":359},[360,361],151.17642,-33.88965,{"lat":361,"lon":360},{"facility":364,"status":51,"city":365,"state":366,"zip":367,"country":356,"countryCode":357,"cosmosGeoPoint":368,"geoPoint":372,"contacts":33},"Southern Oncology Clinical Research Unit (SoCRU)","Bedford Park","South Australia","5042",{"type":58,"coordinates":369},[370,371],138.56815,-35.02204,{"lat":371,"lon":370},{"facility":374,"status":51,"city":375,"state":376,"zip":377,"country":356,"countryCode":357,"cosmosGeoPoint":378,"geoPoint":382,"contacts":33},"Linear Clinical Research Ltd.","Nedlands","Western Australia","6009",{"type":58,"coordinates":379},[380,381],115.8073,-31.98184,{"lat":381,"lon":380},{"type":384,"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":396,"type":397},272,"ESTIMATED","INTERVENTIONAL",[400],"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).",[403,404,405],"Prostate Cancer","Metastatic Castration-resistant Prostate Cancer","Castration Resistant Prostatic Cancer",[403,407],"Castration-resistant prostate cancer","2026-01-15",{"date":410,"type":411},"2026-01-20","ACTUAL",{"date":413,"type":411},"2022-09-15",{"date":415,"type":397},"2028-12",{"name":5,"class":6},35]