A Phase 1b Study of Xaluritamig in People With Castration-Sensitive Prostate Cancer

Full Title

A Phase 1b, Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Subjects With High-risk Biochemical Recurrence of Nonmetastatic Castration-sensitive Prostate Cancer After Definitive Therapy

Purpose

Researchers want to find the best dose of xaluritamig to treat prostate cancer. The people in this study have prostate cancer that has not metastasized (spread) but keeps growing after treatment. Their doctors believe their cancers may respond to hormonal therapies that lower cancer-fueling testosterone. This type of cancer is called non-metastatic castration-sensitive prostate cancer.

Xaluritamig is a bispecific antibody. It binds to 2 different proteins. One is on the surface of cancer cells and one is on cells of the immune system called T cells. Xaluritamig may strengthen your immune system’s ability to fight cancer cells by activating your own cells to destroy your tumor. It is given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have non-metastatic castration-sensitive prostate cancer that keeps growing after treatment with surgery or radiation therapy.
  • Have a PSA level that has doubled in 1 year or less.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information and to see if you can join this study, please call Dr. Daniel Danila’s office at 646-422-4612.

Protocol

25-125

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06555796