Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05519449 · ClinicalTrials.gov registry record · Phase 1
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
A Phase 1 study of Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer, sponsored by Janux Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 272
- Enrollment target
- 20
- Study locations
NCT05519449: Recruiting Phase 1 study of Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer, sponsored by Janux Therapeutics.
NCT05519449 is a Phase 1 study of Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer that is actively recruiting participants, run by Janux Therapeutics. The registered enrollment target is 272 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05519449, a Phase 1 study of Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer, is actively recruiting participants, sponsored by Janux Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 272 participants
- Enrollment target
- 20
- Study locations
Study 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).
Conditions Studied
Interventions
- DRUG Darolutamide
- BIOLOGICAL JANX007
Study Locations (20)
California
- USC Norris Comprehensive Cancer Center - Los Angeles
- UCLA Department of Medicine - Los Angeles
- Hoag Memorial Hospital Presbyterian - Newport Beach
- University of California Davis Comprehensive Cancer Center - Sacramento
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
New York
- Northwell Health R.J. Zuckerberg Cancer Hospital - Lake Success
- Memorial Sloan Kettering Cancer Center - New York
- Weill Cornell Medicine - New York
- Montefiore Medical Center - The Bronx
Minnesota
- University of Minnesota Medical Center - Minneapolis
- Mayo Clinic - Rochester
Alabama
- University of Alabama at Birmingham Hospital - Birmingham
Arizona
- Mayo Clinic - Phoenix
Connecticut
- Yale New Haven Hospital - New Haven
Florida
- Mayo Clinic - Jacksonville
Illinois
- University of Chicago Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 272 participants |
| Start Date | 2022-09-15 |
| Est. Completion | 2028-12 |
| Phase | Phase 1 |
What NCT05519449 shows while recruiting
NCT05519449 is an interventional study that assigns participants to a tested intervention. The registered 272 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (55% lower).
The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Darolutamide is the first listed.
NCT05519449 names 20 study sites across 12 states, led by California, New York, Minnesota.
Frequently Asked Questions
What is clinical trial NCT05519449 about?
NCT05519449 is a clinical study titled "Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)". 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).
What is the current status of trial NCT05519449?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 272 participants. The study started on 2022-09-15. Estimated completion is 2028-12.
What conditions does trial NCT05519449 study?
This clinical trial studies the following conditions: Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer, Castration Resistant Prostatic Cancer.
What interventions are being tested in trial NCT05519449?
The interventions under investigation include: Darolutamide (DRUG), JANX007 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05519449?
This trial is sponsored by Janux Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05519449 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05519449's enrollment target sits among peer trials
272 179th of 735 higher than 557 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors
RECRUITING · Phase 1
-
Phase 1 Trial of ZM008 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy
RECRUITING · Phase 1
-
A Study to Learn How Safe AZD6621 is, How Well it Works, and How it Moves Throughout the Body Over Time, in Adult Male Participants With Metastatic Prostate Cancer
RECRUITING · Phase 1
-
Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02468024 · 272 participants · Phase 3
JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer
- NCT06035939 · 272 participants · NA
SMYLS Multi-site Trial
- NCT06083051 · 272 participants · NA
Differences in Postoperative Symptoms With Four Ureteral Stents
- NCT06449638 · 272 participants · NA
Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI