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Xaluritamig Plus Abiraterone in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
NCT07213674Phase 3
Key facts
- Status
- Recruiting
- Start
- Nov 2025
- Primary completion
- Jan 2030
- Countries
- 18
- Sponsor
- Amgen
- Modality
- Bispecific Antibodies, T-cell Engagers
- Drugs
- xaluritamig
- Conditions
- metastatic castration-resistant prostate cancer (mCRPC)
01
Overview
Phase 3, randomised, open-label trial of xaluritamig in metastatic castration-resistant prostate cancer (mCRPC) (2 arms), sponsored by Amgen. Primary endpoint: Overall Survival. Started Nov 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Xaluritamig Plus Abiraterone
Participants receive xaluritamig IV in combination with abiraterone acetate orally.
Investigator's Choice
Participants receive investigator's choice of abiraterone acetate orally, docetaxel IV Q3W, or cabazitaxel IV Q3W.
03
Who it enrols
Adult males with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on exactly one prior androgen receptor pathway inhibitor (ARPI) and are chemotherapy-naïve in the mCRPC setting.
04
Endpoints
Primary
Overall Survival
Secondary
Radiographic Progression-free Survival
Objective Response
Duration of Response
Disease Control
Progression-free Survival 2
Time to Response
Time to First Subsequent Therapy
Time to Symptomatic Skeletal Events
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