Back to Search Results- Recruiting
- Treatment
- Interventional
- Non Randomized
- Biological
- PHASE1
- Janux Therapeutics
- 18 - 100 Years
Study Purpose
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).
Intervention
Biological : JANX007
Eligibility Requirements
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
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
Recruiting status
Recruiting
Estimated enrollment
105
Study start date
Sep 15, 2022
Study end date
Dec 31, 2026
Last updated
Mar 23, 2025
Primary purpose
Treatment
Design
Interventional
Intervention
Biological
Study phase
PHASE1
Allocation
Non Randomized
Sponsor:
Janux Therapeutics
Collaborator:
N/A
Investigator:
Janux Therapeutics, MD
N/A
Publications
N/A
Websites
N/A
NCT05519449
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