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Recruiting

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

NCT07545811 · Janux Therapeutics
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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: 2026-09-03
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 (6)
UC San Diego Moores Cancer CenterRecruiting
La Jolla, California, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Medical University of South Carolina - Hollings Cancer CenterRecruiting
Charleston, South Carolina, United States
Prisma Health Cancer InstituteRecruiting
Greenville, South Carolina, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
SCRI at Mary CrowleyRecruiting
Dallas, Texas, United States