Open
Actively Recruiting
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
About
Brief 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 administered as a single agent in adults with metastatic castration-resistant prostate cancer (mCRPC).
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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 or PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies
- 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
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Study Stats
Protocol No.
23-000823
Category
Prostate Cancer
Principal Investigator
Contact
Location
- UCLA Santa Monica
- UCLA Westwood