Study of JANX014 in Subjects With Metastatic Castration-Resistant Prostate Cancer

Recruiting now · Phase 1

Conditions studied: Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Castration-resistant Prostate Cancer

In brief

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).

Key facts

Study ID

NCT07545811

Run by

Janux Therapeutics

People needed

43

Starts

2026-04-15

Expected to finish

2029-03-01

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Prisma Health Cancer Institute — Greenville, South Carolina, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• SCRI at Mary Crowley — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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