Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)
NCT06691984 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 707
Last updated 2026-05-15
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
Interventions
- DRUG
-
Short-term IV infusion
- DRUG
-
Abiraterone
Oral tablets
- DRUG
-
Oral tablets
- DRUG
-
Cabazitaxel
IV infusion
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-09
- Primary Completion
- 2029-01-02
- Completion
- 2029-07-30
- FDA Drug
- Yes
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
Study Locations
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