Trials / Recruiting
RecruitingNCT05519449
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 272 (estimated)
- Sponsor
- Janux Therapeutics · Industry
- Sex
- Male
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | JANX007 | JANX007 is dosed via IV in a 21- or 28-day cycle. |
| DRUG | Darolutamide | Darolutamide is dosed via oral tablets |
Timeline
- Start date
- 2022-09-15
- Primary completion
- 2027-07-01
- Completion
- 2028-12-01
- First posted
- 2022-08-29
- Last updated
- 2026-01-20
Locations
35 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05519449. Inclusion in this directory is not an endorsement.