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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05519449
The ClinicalTrials.gov registry entry for NCT05519449 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 272 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (55% lower). The listed sponsor is Janux Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.
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