NCT06613100

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Amgen · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Xaluritamig	Intravenous (IV) infusion
DRUG	GnRH Antagonist	Oral administration

Timeline

• Start date: 2024-11-25
• Primary completion: 2027-01-22
• Completion: 2030-01-23
• First posted: 2024-09-25
• Last updated: 2025-12-01

Locations

8 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study