Amgen Extended Dosing- AMG 509 20250211

What is the 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.

What is the Condition Being Studied?

This study is for adults who have prostate cancer that has spread to other parts of the body. The cancer no longer responds to hormone therapy, which is a common treatment. This type of cancer is called metastatic castration resistant prostate cancer. The study focuses on learning more about this serious condition and finding better ways to treat it.

Who Can Participate in the Study?

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 Group
Adults

What is Involved?

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.

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
George Barth Geller Distinguished Professor for Research in Cancer
Protocol Number
IRB: PRO00120165
NCT: NCT07493512
Phase
Phase I
ClinicalTrials.gov
Status
OPEN TO ACCRUAL
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