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
UC San Diego Moores Cancer Center
La Jolla, California 92037
United States
Washington University School of Medicine
St Louis, Missouri 63108
United States
Medical University of South Carolina - Hollings Cancer Center
Charleston, South Carolina 29425
United States
Prisma Health Cancer Institute
Greenville, South Carolina 29605
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
SCRI at Mary Crowley
Dallas, Texas 75230
United States