Xaluritamig + Androgen Receptor Pathway Inhibitors for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and tolerability of a new treatment, xaluritamig, when combined with existing prostate cancer medications darolutamide or abiraterone. It focuses on men with advanced prostate cancer that has metastasized, especially those who recently began hormone therapy and have multiple areas of cancer spread. Participants must have a confirmed prostate cancer diagnosis and visible signs of cancer spread on scans. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but you cannot have taken certain prostate cancer treatments like enzalutamide or apalutamide within 15 days before joining. If you're on chronic corticosteroids or immunosuppressive therapies, you need to stop them at least 7 days before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that xaluritamig, when combined with other treatments, maintains a reasonable safety record. In earlier studies, patients taking xaluritamig experienced some expected side effects but generally tolerated the treatment well. When combined with darolutamide, most side effects resembled those of other treatments, and there was an improvement in overall survival. Studies also found xaluritamig with abiraterone to be safe and suggested positive outcomes for patients who had previously tried other treatments.
Since this trial is in its early stages, the main goal is to assess the safety and tolerability of these combinations. Detailed safety information is still being collected. However, the FDA has already approved abiraterone and darolutamide for treating prostate cancer, indicating that their safety is well understood.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Xaluritamig for prostate cancer because it offers a unique approach by potentially enhancing the effects of existing androgen receptor pathway inhibitors like Abiraterone and Darolutamide. Most treatments for prostate cancer work by blocking the effects of androgens, which fuel cancer growth. However, Xaluritamig may work differently by amplifying the ability of these inhibitors to suppress the cancer more effectively. This combination approach aims to improve outcomes for patients by potentially reducing cancer progression more efficiently than current treatments alone.
What evidence suggests that this trial's treatments could be effective for prostate cancer?
In this trial, participants will receive xaluritamig combined with either darolutamide or abiraterone. Previous studies have shown that xaluritamig yields promising results for treating advanced prostate cancer. Patients taking xaluritamig experienced strong and long-lasting effects. Specifically, when combined with darolutamide, the overall survival rate improved significantly compared to not using the treatment. Similarly, when used with abiraterone, xaluritamig also led to a notable increase in survival rates. This suggests that xaluritamig, when used with these medications, could be a powerful option for managing prostate cancer.12678
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
This trial is for men with metastatic hormone-sensitive prostate cancer. They must have confirmed adenocarcinoma of the prostate, no prior docetaxel treatment, and not be progressing after initial ADT therapy. High-volume disease is required, but mixed histologies or previous localized cancer treatments are disqualifiers.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive xaluritamig in combination with darolutamide or abiraterone
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Abiraterone
- Darolutamide
- Xaluritamig
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London