Purpose of this Study
In this study, all participants will receive a study medicine called xaluritamig through a tube placed in a vein. Each treatment takes about one hour. At the start, lower doses are given every two weeks. Later, treatments are given every four weeks. Before starting, you will have tests such as blood work, scans, and a physical exam to make sure you can join the study. During the study, you will have regular clinic visits for treatments, checkups, blood tests, and scans like CT or MRI to watch your health and your cancer. Early in treatment, you may need to stay at the clinic or hospital for a short time after the medicine is given so doctors can monitor you. You will also need a caregiver to help you for a short time after treatment. You can keep receiving the medicine as long as it is helping you, and doctors will continue to check on you for up to about two years.
Who Can Participate?
Eligibility
People may be able to join this study if they are 18 years old or older and have prostate cancer that has spread to other parts of the body and does not respond to hormone therapy. They must have already received other treatments, including hormone therapy, targeted therapy, and chemotherapy. Their cancer must be getting worse based on scans or lab tests.
People cannot join if the cancer has spread to the brain or if they have another active cancer. They also cannot join if they have certain lung problems, such as interstitial lung disease, pneumonitis, or uncontrolled asthma. People who have had an organ transplant cannot take part in this study.
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
This study is testing a new medicine called xaluritamig for people with advanced prostate cancer. Researchers want to learn if this medicine is safe and if it can help shrink the cancer. The goal is to find better treatment options for people with this type of cancer in the future.
Locations
Duke University Hospital
Duke Raleigh Hospital
Other
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
Amgen Extended Dosing- AMG 509 20250211- A Phase 1b, Open-Label Study of Xaluritamig (AMG 509) in Adults With Metastatic Castration-Resistant Prostate Cancer
Principal Investigator
Andrew
Armstrong
Protocol Number
PRO00120165
NCT ID
NCT07493512
Phase
I
Enrollment Status
Pending Open to Enrollment