[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634909":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":46,"collaborators":24,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":24,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":24,"enrollmentInfo":57,"targetDuration":24,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":24,"overallStatus":34,"whyStopped":24,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Janux Therapeutics","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation","EXPERIMENTAL","JANX014 will be administered at increasing dose levels per cohort to determine the maximum tolerated dose.",[13],"Biological: JANX014",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose Expansion","Participants will be dosed at levels previously declared tolerable.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","JANX014","JANX014 will be administered via IV dosing",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Janux Therapeutics, MD","CONTACT","+1 858-206-8471","PRCA-014-001_ct.gov@januxrx.com",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":24},"Research Site","RECRUITING","Nashville","Tennessee","37203","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-86.78444,36.16589,{"lat":44,"lon":43},{"type":47,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100634909","phase-1-study-of-janx014-in-subjects-with-metastatic-castration-resistant-prostate-cancer-100634909",false,"NCT07545811","Study of JANX014 in Subjects With Metastatic Castration-Resistant Prostate Cancer","A Phase 1 Open-Label, Multicenter Study of JANX014 in Participants With 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: 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 Dose Expansion Part: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1 prior taxane regimen in the HSPC 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 any CAR-T cell therapy, approved or investigational T-cell engager therapy, and prior receipt of radioligand therapy\n* Clinically significant cardiovascular disease","MALE","18 Years",{"count":58,"type":59},43,"ESTIMATED","INTERVENTIONAL",[62],"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 JANX014 in adults with metastatic castration-resistant prostate cancer (mCRPC).",[65,66,67],"Prostate Cancer","Metastatic Castration-resistant Prostate Cancer","Castration-resistant Prostate Cancer","2026-04-16",{"date":70,"type":71},"2026-04-22","ACTUAL",{"date":73,"type":71},"2026-04-15",{"date":75,"type":59},"2029-03",{"name":5,"class":6},1]