Phase 3 Clinical Trial for Xaluritamig (AMG 509) in Advanced Prostate Cancer Set to Open for Recruitment Soon

A Phase 3 clinical trial is underway to evaluate the efficacy and safety of xaluritamig (AMG 509), a potential new treatment for metastatic castration-resistant prostate cancer (mCRPC). This trial aims to determine if xaluritamig offers better outcomes compared to standard therapies such as cabazitaxel or a second androgen receptor-directed therapy (ARDT) like enzalutamide or abiraterone acetate.

Eligible participants are adult patients with a confirmed diagnosis of adenocarcinoma of the prostate who meet specific criteria, including:

  • At least one confirmed metastatic lesion.
  • Evidence of progressive disease.
  • Prior treatment with androgen deprivation therapy (ADT) and at least one taxane-based chemotherapy.
  • No prior STEAP1-targeted therapy.
  • No anticancer therapy, immunotherapy, or investigational agents within four weeks before starting the study.
  • No recent PSMA radioligand therapy (RLT) within the last two months unless limited to two cycles.
  • No history of allergic reactions to the study drugs.
  • No active autoimmune disease requiring systemic treatment or chronic gastrointestinal issues.

Participants will be randomly assigned to one of two groups:

  1. The investigational group receiving xaluritamig (AMG 509).
  2. The control group receiving cabazitaxel or a second ARDT, as decided by the study doctor.

This trial aims to address the urgent need for effective treatments for mCRPC patients who no longer respond to standard therapies. By evaluating xaluritamig’s ability to target and treat this advanced form of prostate cancer, the study could provide a new therapeutic option and improve patient outcomes. The trial is being conducted at multiple research centers (Indiana University, Duke, City of Hope…).

It is supposed to start enrolling in January 2025.

To find all the centers the bst way is to use Google search and look for:

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

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