Full Title
A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-resistant Prostate CancerPurpose
Prostate cancers initially need the male hormone testosterone for growth. Hormone therapies that lower the level of testosterone are among the most effective treatments for prostate cancers that have spread to other organs (metastasized). The benefits of hormone treatments do not last, however. Over time, many prostate cancers continue to grow despite hormonal therapies; these are called “castration-resistant prostate cancers” (CRPC).
In this study, researchers want to find the highest dose of the investigational drug AMG 509 that can be used safely in patients with CRPC. AMG 509 is a bispecific antibody that binds to two different proteins; one found on the surface of cancer cells and one on the surface of T cells in the immune system. Researchers think that AMG 509 may strengthen the immune system’s ability to fight cancer cells. It is given intravenously (by vein).