Study of JANX014 in Subjects With Metastatic Castration-Resistant Prostate Cancer
Recruiting · NCT07545811 · Interventional (participants receive a specific treatment) · Lead sponsor: Janux Therapeutics
View the official record on ClinicalTrials.gov →Interventions studied
JANX014
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
6 locations listed across 5 US states.
- UC San Diego Moores Cancer Center - La Jolla, California, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- Medical University of South Carolina - Hollings Cancer Center - Charleston, South Carolina, United States
- Prisma Health Cancer Institute - Greenville, South Carolina, United States
- SCRI Oncology Partners - Nashville, Tennessee, United States
- SCRI at Mary Crowley - Dallas, Texas, United States