Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called xaluritamig (the study drug). We want to know how well this drug works compared to the standard drugs for people who have metastatic castration-resistant prostate cancer.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with adenocarcinoma of the prostate
- Have had a previous orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone
- Have received previous treatment with at least one ARDT and one taxane therapy
- Have never received STEAP1-targeted therapy
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment to either:
- Get the study drug; OR
- Get the standard treatment for this type of cancer
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Chemotherapy, 20230005
Principal Investigator
Andrew
Armstrong
Protocol Number
PRO00116828
Phase
III
Enrollment Status
Pending Open to Enrollment