Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
About the study
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 administered as a single agent in adults with metastatic castration-resistant prostate cancer (mCRPC).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Male ≥18 years of age at the time of signing informed consent
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- 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
EXCLUSION CRITERIA
Exclusion Criteria:
- Prior solid organ transplant
- Prior treatment with PSMA-targeted CAR-T cell therapy
- Clinically significant cardiovascular disease
- 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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Prostate Cancer,Metastatic Castration-resistant Prostate Cancer,Castration Resistant Prostatic Cancer
Age (in years)
18 - 100
Phase
Phase 1
Participants needed
105
Est. Completion Date
Mar 31, 2025
Treatment type
Interventional
Sponsor
Janux Therapeutics
ClinicalTrials.gov identifier
NCT05519449
Study number
PSMA-007-001
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