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

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.

Eligibility

Age range: 18+ years
Sex: Male
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: Participants are eligible to be included in the study only if all the following criteria apply: * Participants planned to undergo radical prostatectomy. * Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features. Intermediate- or high-risk localized prostate cancer, defined as: * Gleason score of 4+3 or higher AND initial PSA (iPSA) \>10 OR * Clinically advanced (cT3) on Magnetic Resonance Imaging (MRI) obtained within 3 months prior to screening AND/OR *…

Locations (9)

University of California San Francisco
San Francisco, California
Washington University
St Louis, Missouri
The Ohio State University
Columbus, Ohio
Thomas Jefferson University
Philadelphia, Pennsylvania
Carolina Urologic Research Center
Myrtle Beach, South Carolina
Fred Hutchinson Cancer Center
Seattle, Washington

Summary

Eligibility

Interventions

Locations (9)