OncoMatch/Clinical Trials/NCT05519449
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
Is NCT05519449 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including JANX007 and Darolutamide for prostate cancer.
Treatment: JANX007 · Darolutamide — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Endocrine / hormonal
Other
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Demographics
Prior therapy
Must have received: antiandrogen — HSPC or CRPC
progressed after at least one novel anti-androgen therapy
Must have received: taxane
at least one taxane containing regimen. Participants who have actively refused a taxane containing regimen or are medically unsuitable to receive taxane are eligible
Cannot have received: PSMA-targeted CAR-T cell therapy
Prior treatment with PSMA-targeted CAR-T cell therapy
Cannot have received: PSMA-CD3 bispecific antibody
Prior treatment with PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies
Cannot have received: radioligand therapy
Prior treatment with ... radioligand therapy
Lab requirements
Blood counts
Kidney function
Liver function
Adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham Hospital · Birmingham, Alabama
- Mayo Clinic · Phoenix, Arizona
- USC Norris Comprehensive Cancer Center · Los Angeles, California
- UCLA Department of Medicine · Los Angeles, California
- Hoag Memorial Hospital Presbyterian · Newport Beach, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05519449 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior PSMA-targeted CAR-T cell therapy, PSMA-CD3 bispecific antibody, radioligand therapy disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 100 years or younger.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages