NCT07140900

Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer

A Phase 1b Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Amgen · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.

Conditions

• Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Interventions

Type	Name	Description
DRUG	Xaluritamig	Participants will receive xaluritamig intravenously.
DRUG	Darolutamide	Participants will receive darolutamide orally.
DRUG	Abiraterone	Participants will receive abiraterone orally.

Timeline

• Start date: 2025-10-07
• Primary completion: 2028-03-27
• Completion: 2030-03-30
• First posted: 2025-08-26
• Last updated: 2026-02-13

Locations

11 sites across 3 countries: United States, Australia, Switzerland

Regulatory

• FDA-regulated drug study