[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655419":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":11,"studyPopulation":11,"armGroups":41,"interventions":53,"overallOfficials":11,"centralContacts":69,"locations":75,"responsibleParty":90,"collaborators":11,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":11,"enrollmentInfo":102,"targetDuration":11,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":114,"overallStatus":78,"whyStopped":11,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Janux Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)",null,"2 years",{"measure":14,"description":15,"timeFrame":12},"Incidence of cytokine release syndrome (CRS)","Cytokine release syndrome (CRS) assessed according to ASTCT criteria.",[17,20,22,24,26,28,30,32],{"measure":18,"description":11,"timeFrame":19},"Area under the curve from 0 to t of JANX013 and JANX007","Up to 2 years",{"measure":21,"description":11,"timeFrame":19},"Maximum observed concentration of JANX013 and JANX007",{"measure":23,"description":11,"timeFrame":19},"Time to maximum concentration of JANX013 and JANX007",{"measure":25,"description":11,"timeFrame":19},"Number of participants who develop anti-drug antibodies (ADAs) against JANX013 and JANX007",{"measure":27,"description":11,"timeFrame":19},"Prostate-specific antigen (PSA) response",{"measure":29,"description":11,"timeFrame":19},"Radiographic progression-free survival (rPFS)",{"measure":31,"description":11,"timeFrame":19},"Duration of response (DOR)",{"measure":33,"description":11,"timeFrame":19},"Disease control rate (DCR)",{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":11,"timePerspective":11,"maskingInfo":39},"NON_RANDOMIZED","SEQUENTIAL","Participants are assigned to sequential cohorts in a dose-escalation phase followed by dose-expansion cohorts evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of JANX013 in combination with JANX007 in participants with metastatic castration-resistant prostate cancer.","TREATMENT",{"masking":40,"maskingDescription":11,"whoMasked":11},"NONE",[42,49],{"label":43,"type":44,"description":45,"interventionNames":46},"Dose Escalation","EXPERIMENTAL","Participants receive JANX013 in combination with JANX007 administered at increasing dose levels per cohort",[47,48],"Drug: JANX013","Drug: JANX007",{"label":50,"type":44,"description":51,"interventionNames":52},"Dose Expansion","Participants receive JANX013 in combination with JANX007. Participants will be dosed at levels previously declared tolerable.",[47,48],[54,59,63,66],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":11},"DRUG","JANX013","JANX013 will be administered via IV dosing.",[43],{"type":55,"name":60,"description":61,"armGroupLabels":62,"otherNames":11},"JANX007","JANX007 will be administered via IV dosing.",[43],{"type":55,"name":56,"description":64,"armGroupLabels":65,"otherNames":11},"JANX013 will be administered via IV dosing",[50],{"type":55,"name":60,"description":67,"armGroupLabels":68,"otherNames":11},"JANX007 will be administered via IV dosing",[50],[70],{"name":71,"role":72,"phone":73,"phoneExt":11,"email":74},"Janux Therapeutics, MD","CONTACT","1-858-206-8471","PSMA-013-001_ct.gov@januxrx.com",[76],{"facility":77,"status":78,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":11},"Sarah Cannon Research Institute","RECRUITING","Nashville","Tennessee","37203","United States","US",{"type":85,"coordinates":86},"Point",[87,88],-86.78444,36.16589,{"lat":88,"lon":87},{"type":91,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100655419","phase-1-phase-1-trial-to-study-janx013-and-janx007-combination-in-mcrpc-100655419",false,"NCT07813637","Phase 1 Trial to Study JANX013 and JANX007 Combination in mCRPC","A Phase 1 Open-Label, Multicenter Study of JANX013 Combined With JANX007 in Participants With Metastatic Castration Resistant Prostate Cancer","PSMA-013-001","Key Inclusion Criteria:\n\n* Male participants ≥ 18 years of age at the time of signing informed consent\n* Histologically or cytologically confirmed adenocarcinoma of the prostate\n\nFor Dose Escalation:\n\n\\- Have received at least 1 novel ARPI (e.g., abiraterone acetate, enzalutamide, apalutamide, or darolutamide) in any setting and have received at least 1 taxane regimen (in any setting), or who are medically unsuitable or have actively refused treatment with a taxane regimen.\n\nFor Dose Expansion:\n\n* Must be in the first-line or second-line setting for mCRPC or metastatic androgen pathway modulation resistant disease and must have received 1 novel ARPI in any setting.\n* Adequate organ function\n\nKey Exclusion Criteria:\n\n* Prior treatment with any chimeric antigen receptor (CAR) T-cell therapy, any approved or investigational TCE, or any T-cell costimulatory agent\n* Clinically significant cardiovascular disease\n* Prior solid organ transplant","MALE","18 Years",{"count":103,"type":104},110,"ESTIMATED","INTERVENTIONAL",[107],"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 JANX013 in combination with JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).",[110,111,112,113],"Prostate Cancer","Castration-Resistant Prostate Cancer (CRPC)","Metastatic Prostate Cancer","Metastatic Castration-Resistant Prostate Cancer Patients",[115,116,117,118,119,120,121,122,123],"mCRPC","Metastatic Castration-Resistant Prostate Cancer","PSMA","Prostate-Specific Membrane Antigen","CD3 T cell engager","T cell engager","Bispecific antibody","Immunotherapy","Prostate cancer metastatic","2026-09-15",{"date":126,"type":127},"2026-09-17","ACTUAL",{"date":129,"type":127},"2026-09-10",{"date":131,"type":104},"2030-07",{"name":5,"class":6},1]