RecruitingRecruiting
Study of JANX014 in Subjects With Metastatic Castration-Resistant Prostate Cancer
NCT07545811 · Janux Therapeutics
In plain English
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Official title
A Phase 1 Open-Label, Multicenter Study of JANX014 in Participants With Prostate Cancer
About this 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 JANX014 in adults with metastatic castration-resistant prostate cancer (mCRPC).
Eligibility criteria
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
Study design
Enrollment target: 43 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-04-15
Estimated completion: 2029-03
Last updated: 2026-04-22
Interventions
Biological: JANX014
Primary outcomes
- • Incidence of Dose Limiting Toxicities (DLTs) (2 years)
- • Incidence of adverse events (AE) and Serious Adverse Events (SAE) (2 years)
Sponsor
Janux Therapeutics · industry
Contacts & investigators
ContactJanux Therapeutics, MD · contact · PRCA-014-001_ct.gov@januxrx.com · +1 858-206-8471
All locations (1)
Research SiteRecruiting
Nashville, Tennessee, United States