NCT06691984

Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)

A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Chemotherapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 675 (estimated)
• Sponsor: Amgen · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the study is to compare overall survival in participants receiving xaluritamig versus investigator's choice (cabazitaxel or second androgen receptor-directed therapy \[ARDT\]).

Conditions

• Metastatic Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	Xaluritamig	Short-term IV infusion
DRUG	Abiraterone	Oral tablets
DRUG	Enzalutamide	Oral tablets
DRUG	Cabazitaxel	IV infusion

Timeline

• Start date: 2024-12-09
• Primary completion: 2029-01-02
• Completion: 2029-07-30
• First posted: 2024-11-18
• Last updated: 2026-03-06

Locations

164 sites across 22 countries: United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Greece, Hong Kong, Italy, Japan, Netherlands, Poland, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study