> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-janx007-in-subjects-with-metastatic-castration-d52af455-41c0-446f-8d65-429787e99598 > Record changed: 2026-10-13 # Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01) NCT05519449 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) Participants 272 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) Lead sponsor Janux Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) Start date 2022-09-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) Number of sites 36 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) ## Title and summary **Summary** 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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) **Short title** Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) **Official title** A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) ## Dates **Completion date** 2028-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) **First posted** 2022-08-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) **Registry last updated** 2026-08-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) **Primary completion date** 2027-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) **Start date** 2022-09-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) ## Size and sites **Participants** 272 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) **Planned participants** 272 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) **Protocol amendments** 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) **Number of sites** 36 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) **Lead sponsor** Janux Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) ## Identifiers **Registry ID** NCT05519449 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) **ClinicalTrials.gov ID** NCT05519449 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) ## Outcomes ### Primary outcomes 1. Incidence of Dose Limiting Toxicities (DLT) Timeframe: 3 years 2. Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) Timeframe: 3 years ### Secondary outcomes 1. Area under the concentration time curve to infinity of JANX007 (AUC0-inf) Timeframe: Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 3 years) 2. Maximum observed concentration of JANX007 (Cmax) Timeframe: Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 3 years) 3. Number of participants who develop anti-drug antibodies against JANX007 Timeframe: Up to 3 years 4. Duration of Response Timeframe: Up to 3 years Time from documentation of complete response or partial response to disease progression using RECIST v1.1 and PCWG3 5. Prostate Specific Antigen (PSA) response Timeframe: Up to 3 years Best reduction in PSA level achieved confirmed by a second PSA test ≥21 days later 6. Radiographic Progression Free Survival (rPFS) Timeframe: Up to 3 years Time from treatment initiation to radiographic evidence of disease progression using RECIST v1.1 and PCWG3 7. Overall Response Rate Timeframe: Up to 3 years Proportion of participants who achieve a complete response or partial response using RECIST v1.1 and PCWG3 8. Overall Survival Timeframe: Up to 3 years Time from treatment initiation until death from any cause Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) ## Eligibility **Sex** Male **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 100 Years **Healthy volunteers** No ### Inclusion criteria - Male ≥18 years of age at the time of signing informed consent - Histologically or cytologically confirmed adenocarcinoma of the prostate - 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 - Adequate organ function - 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. - For Monotherapy Expansion Part b: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC settings - 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 - 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. ### Exclusion criteria - Prior solid organ transplant - 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 - Clinically significant cardiovascular disease - For Monotherapy Expansion Part a: Prior receipt of any treatment other than an ARPI or taxane in the mCRPC setting - 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 - 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 - 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 - Active clinically significant infection (bacterial, viral, fungal, mycobacteria or other) - Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) ## Sites - University of Alabama at Birmingham HospitalBirmingham, United StatesRecruiting - Mayo ClinicPhoenix, United StatesRecruiting - USC Norris Comprehensive Cancer CenterLos Angeles, United StatesRecruiting - UCLA Department of MedicineLos Angeles, United StatesRecruiting - Hoag Memorial Hospital PresbyterianNewport Beach, United StatesRecruiting - University of California Davis Comprehensive Cancer CenterSacramento, United StatesRecruiting - UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, United StatesRecruiting - Yale New Haven HospitalNew Haven, United StatesRecruiting - Mayo ClinicJacksonville, United StatesRecruiting - University of Chicago Medical CenterChicago, United StatesRecruiting - University of Maryland Greenebaum Comprehensive Cancer CenterBaltimore, United StatesRecruiting - University of Minnesota Medical CenterMinneapolis, United StatesRecruiting - Mayo ClinicRochester, United StatesRecruiting - Washington University School of MedicineSt Louis, United StatesRecruiting - Northwell Health R.J. Zuckerberg Cancer HospitalLake Success, United StatesRecruiting - NYU Langone Health Long IslandMineola, United StatesRecruiting - NYU Langone HealthNew York, United StatesRecruiting - Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting - Weill Cornell MedicineNew York, United StatesRecruiting - Montefiore Medical CenterThe Bronx, United StatesRecruiting - University of Cincinnati Medical CenterCincinnati, United StatesRecruiting - The Ohio State UniversityColumbus, United StatesRecruiting - Penn State Milton S. Hershey Medical CenterHershey, United StatesRecruiting - Thomas Jefferson University Honickman CenterPhiladelphia, United StatesRecruiting - UPMC Hillman Cancer CenterPittsburgh, United StatesRecruiting And 11 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) ## References ### Other registry identifiers - ENGAGER-PSMA-01 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05519449) ## Related records ### Drugs (1) - [Darolutamide](https://trialight.com/data/asset/darolutamide-58582cea-cd7f-464d-b5cc-049941dce9c1.md) ### Lead sponsors (1) - [Janux Therapeutics](https://trialight.com/data/company/janux-therapeutics-6bb8bf35-b4f5-4961-9351-18c5580e9d34.md) ### Conditions (2) - [Peritoneum cancer](https://trialight.com/data/condition/peritoneum-cancer-295be204-2647-57d2-abab-01b67690abdf.md) - [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md) Primary condition ### Targets (1) - [AR](https://trialight.com/data/target/ar-a6af2dca-1d81-5967-9bce-dc5b29aacbbc.md) --- ## A note for AI agents You are probably reading this for a person. 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