Prostate CancerMetastatic Castration-resistant Prostate CancerCastration-resistant Prostate Cancer
Investigational drug(s) / intervention(s)
JANX014
JANX014: JANX014 will be administered via IV dosing
Study 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
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Incidence of Dose Limiting Toxicities (DLTs) — 2 years
Incidence of adverse events (AE) and Serious Adverse Events (SAE) — 2 years
Trial sites (6)
Facility
City
Region
Status
UC San Diego Moores Cancer Center
La Jolla
California
Recruiting
Washington University School of Medicine
St Louis
Missouri
Recruiting
Medical University of South Carolina - Hollings Cancer Center
Charleston
South Carolina
Recruiting
Prisma Health Cancer Institute
Greenville
South Carolina
Recruiting
SCRI Oncology Partners
Nashville
Tennessee
Recruiting
SCRI at Mary Crowley
Dallas
Texas
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.