Study of JANX014 in Subjects With Metastatic Castration-Resistant 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).
- Condition
- Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Castration-resistant Prostate Cancer
- Tested
- JANX014
- Sponsor
- Janux Therapeutics
Who can join
- Age
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Eligible sex: Male
- Study condition: Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Castration-resistant Prostate Cancer
- 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 3
- 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
6 sites, 6 recruiting
Medical University of South Carolina - Hollings Cancer Center
Charleston, South Carolina, United States
SCRI at Mary Crowley
Dallas, Texas, United States
Prisma Health Cancer Institute
Greenville, South Carolina, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Washington University School of Medicine
St Louis, Missouri, United States
Contact
-
Janux Therapeutics, MD
+1 858-206-8471 PRCA-014-001_ct.gov@januxrx.com
Potential match only. Final eligibility is determined by the study team.