Amgen Phase 3: Xaluritamig vs Cabazitaxel or Second ARDT in mCRPC (Prostate Cancer)

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
For more information, contact the study team at julia.hurrelbrink@duke.edu

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
You will have a 2-in-3 chance of getting the study drug and a 1-in-3 chance of getting the standard treatment. The standard treatment will involve taking a drug called cabazitaxel or 1 of 2 drugs classified as androgen receptor directed therapies (enzalutamide or abiraterone acetate). You and the study doctor will discuss which standard therapy is most appropriate before you get your study assignment. You will take part in the study for up to 56 months, including a minimum of 36 months of drug regimen and follow-up. The amount of time you take the study drug or standard treatment will vary and depends on how well you tolerate or respond to your assigned study regimen.

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