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
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 *…
Interventions
- DrugXaluritamig
Intravenous (IV) infusion
- DrugGnRH Antagonist
Oral administration
Locations (8)
- University of California San FranciscoSan Francisco, California
- Washington UniversitySt Louis, Missouri
- The Ohio State UniversityColumbus, Ohio
- Thomas Jefferson UniversityPhiladelphia, Pennsylvania
- Fred Hutchinson Cancer CenterSeattle, Washington
- Medical College of WisconsinMilwaukee, Wisconsin