RecruitingPhase 1NCT06613100

Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer

A Phase 1b, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, and Feasibility of Neoadjuvant Xaluritamig Therapy Prior to Radical Prostatectomy in Subjects With Newly Diagnosed Localized Intermediate or High-Risk Prostate Cancer


Sponsor

Amgen

Enrollment

40 participants

Start Date

Nov 25, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objectives of this study are to evaluate the safety and tolerability of xaluritamig administered as monotherapy or in combination with an oral Gonadotropin-releasing Hormone (GnRH) antagonist in the neoadjuvant setting followed by radical prostatectomy, and to evaluate the feasibility and safety of a radical prostatectomy following xaluritamig administered as monotherapy or in combination with an oral GnRH antagonist in the neoadjuvant setting.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called xaluritamig given before surgery (called neoadjuvant therapy) in people with localized prostate cancer who are scheduled for radical prostatectomy (surgical removal of the prostate). The goal is to see whether this drug can help shrink or eliminate cancer cells before surgery. **You may be eligible if...** - You are scheduled to have your prostate surgically removed - You have been diagnosed with prostate adenocarcinoma confirmed by biopsy - Your cancer is localized (has not spread to distant organs) - You are in good physical health **You may NOT be eligible if...** - You have a neuroendocrine or small cell type prostate cancer - You have already received hormone therapy, chemotherapy, or radiation for this cancer - You have significant heart, kidney, or liver problems - You are on medications that interfere with the study drug 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

Intravenous (IV) infusion

DRUGGnRH Antagonist

Oral administration


Locations(8)

University of California San Francisco

San Francisco, California, United States

Washington University

St Louis, Missouri, United States

The Ohio State University

Columbus, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Universitaetsklinikum Essen

Essen, Germany

Universitaetsklinikum Hamburg Eppendorf

Hamburg, Germany

View Full Details on ClinicalTrials.gov

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NCT06613100


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