Phase I
A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer
- Study HIC#:2000034572
- Last Updated:10/10/2024
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).
Contact Us
For more information about this study, including how to volunteer, contact:
Joseph Kim
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Eligibility 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:
- 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
