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Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer
Sponsor: Amgen
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.
Official title: 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
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-11-25
Completion Date
2030-01-23
Last Updated
2025-12-01
Healthy Volunteers
No
Conditions
Interventions
Xaluritamig
Intravenous (IV) infusion
GnRH 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