RecruitingPhase 1NCT07140900

Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer

A Phase 1b Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer


Sponsor

Amgen

Enrollment

60 participants

Start Date

Oct 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called xaluritamig — a bispecific antibody that helps immune cells target and kill prostate cancer cells — in combination with hormone-blocking treatments in men with metastatic hormone-sensitive prostate cancer (cancer that has spread but still responds to hormone therapy). **You may be eligible if...** - You are a man with prostate cancer confirmed by biopsy - Your cancer has spread to other parts of the body (metastatic) and was recently diagnosed as hormone-sensitive (still responding to androgen deprivation therapy) - You started hormone-blocking therapy no more than 12 weeks before the study screening - You meet organ function and health status requirements **You may NOT be eligible if...** - Your prostate cancer has a neuroendocrine component - You have previously been treated with docetaxel chemotherapy for prostate cancer - You have significant heart disease or active serious infections - You have had prior treatment with certain immunotherapy drugs - You are unable to follow the study schedule Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXaluritamig

Participants will receive xaluritamig intravenously.

DRUGDarolutamide

Participants will receive darolutamide orally.

DRUGAbiraterone

Participants will receive abiraterone orally.


Locations(11)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Chris OBrien Lifehouse

Camperdown, New South Wales, Australia

Calvary Mater Newcastle Hospital

Waratah, New South Wales, Australia

Cabrini Hospital

Clayton, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Kantonsspital Graubuenden

Chur, Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Kantonsspital Sankt Gallen

Sankt Gallen, Switzerland

View Full Details on ClinicalTrials.gov

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NCT07140900


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