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RECRUITING
NCT06613100
PHASE1

Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer

Sponsor: Amgen

View on ClinicalTrials.gov

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

DRUG

Xaluritamig

Intravenous (IV) infusion

DRUG

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