Xaluritamig + Abiraterone for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of medications, xaluritamig (an experimental treatment) and abiraterone, to determine if they extend the lives of patients with advanced prostate cancer. The trial compares this combination to other treatments such as docetaxel, cabazitaxel, or abiraterone alone. Men with metastatic castration-resistant prostate cancer, which has spread and is unresponsive to hormone therapy, may be suitable candidates. Participants must have previously undergone hormone therapy or surgery to reduce testosterone. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial requires that you stop taking any anticancer therapy, immunotherapy, or investigational agents at least 4 weeks before starting the study treatment, except for ongoing androgen suppression therapy. You cannot take concurrent chemotherapy, ARPI, immunotherapy, or certain other therapies during 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 abiraterone, is generally safe. Studies indicate that even patients with extensive prior treatments tolerated this combination well. One study examined xaluritamig with either darolutamide or abiraterone and also found it to be safe and tolerable.
Abiraterone is already used to treat prostate cancer, and its safety profile is well-established. It is usually well-tolerated, though some individuals might experience tiredness or high blood pressure, which are typically manageable.
Overall, the combination of xaluritamig and abiraterone appears promising in terms of safety, with few serious side effects reported in previous studies.12345Why do researchers think this study treatment might be promising for prostate cancer?
Researchers are excited about Xaluritamig for prostate cancer because it introduces a novel way to tackle the disease. Unlike standard treatments like Abiraterone alone or chemotherapy options such as Docetaxel and Cabazitaxel, Xaluritamig targets specific cancer pathways in combination with Abiraterone, potentially enhancing efficacy. This combination approach aims to disrupt cancer growth more effectively and could offer new hope for patients by potentially improving outcomes compared to existing therapies.
What evidence suggests that xaluritamig plus abiraterone could be an effective treatment for prostate cancer?
This trial will compare the combination of Xaluritamig and Abiraterone with the investigator's choice of standard treatments. Studies have shown that using Xaluritamig with Abiraterone for prostate cancer appears promising. Specifically, research indicates that this combination led to a significant decrease in prostate cancer markers in 49% of patients with advanced stages of the disease. Additionally, previous patients demonstrated very encouraging results, even after trying other treatments. This suggests that the combination might help prostate cancer patients live longer compared to some existing treatments.12678
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
Men with advanced prostate cancer that has spread and is resistant to hormone therapy can join. They must have rising PSA levels, confirmed adenocarcinoma of the prostate without mixed histologies, at least one metastatic lesion visible on scans, and prior treatment with only one type of ARPI drug. Men over 18 who consent to participate are eligible unless they've had more than one ARPI or certain other treatments.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive xaluritamig plus abiraterone or investigator's choice of treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Abiraterone
- Xaluritamig
Trial Overview
The study aims to see if Xaluritamig combined with Abiraterone improves survival compared to the doctor's choice of Docetaxel, Cabazitaxel, or Abiraterone alone in men whose prostate cancer hasn't been treated with chemotherapy but is spreading despite hormone therapy.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will be randomized to receive xaluritamig in combination with abiraterone acetate.
Participants will receive investigator's choice of: * Abiraterone acetate orally, once daily or * Docetaxel IV Q3W or * Cabazitaxel IV Q3W.
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
Citations
NCT07213674 | A Study of Xaluritamig Plus Abiraterone ...
The primary objective of this study is to compare overall survival (OS) in participants receiving xaluritamig plus abiraterone against investigator's choice ( ...
2.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/AMGN/pressreleases/35744552/amgens-new-prostate-cancer-study-a-potential-game-changer/Amgen's New Prostate Cancer Study: A Potential Game- ...
' The study aims to compare overall survival rates between patients receiving a combination of xaluritamig and abiraterone against those ...
Xaluritamig: a first step towards a new target, new mechanism ...
In addition to the reasonable safety profile observed, the study demonstrated very encouraging signs of efficacy in this heavily pre-treated ...
NCT07140900 | Study Evaluating the Safety, Tolerability, ...
A Phase 1b Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway ...
Xaluritamig vs Other Treatments for Prostate Cancer
In a study with 97 patients having advanced prostate cancer, Xaluritamig showed promising results, with 49% of patients experiencing a significant drop in ...
NCT07140900 | Study Evaluating the Safety, Tolerability, ...
Study Overview. The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.
7.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/AMGN/pressreleases/35744588/amgens-new-study-on-xaluritamig-a-potential-game-changer-in-prostate-cancer-treatment/Amgen's New Study on Xaluritamig: A Potential Game ...
The study aims to assess the safety and tolerability of xaluritamig when used alongside darolutamide or abiraterone in treating metastatic ...
The Safety of Abiraterone Acetate in Patients with Metastatic ...
The Safety of Abiraterone Acetate in Patients with Metastatic Castration-Resistant Prostate Cancer: An Individual-Participant Data Meta ...
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