NCT07545811PHASE1Recruiting
Study of JANX014 in Subjects With Metastatic Castration-Resistant Prostate Cancer
Janux Therapeutics
Start Date
4/15/2026
Completion Date
3/1/2029
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 JANX014 in adults with metastatic castration-resistant prostate cancer (mCRPC).
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* Male ≥18 years of age at the time of signing informed consent
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* For Dose Escalation: 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
* For Dose Expansion Part: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1 prior taxane regimen in the HSPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.
Exclusion Criteria:
* Prior solid organ transplant
* Prior treatment with any CAR-T cell therapy, approved or investigational T-cell engager therapy, and prior receipt of radioligand therapy
* Clinically significant cardiovascular disease
Interventions
BIOLOGICAL
JANX014
Conditions
Prostate CancerMetastatic Castration-resistant Prostate CancerCastration-resistant Prostate Cancer
Locations
Research Site
Nashville, Tennessee 37203
United States