Clinical Trial: NCT06691984
Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Amgen |
| Information Provided By: | Amgen |
| Last Update Posted: | 2026-05-15 |
Study Overview
Brief 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]).
Official Title
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
Conditions
Metastatic Castration-resistant Prostate Cancer
Intervention / Treatment
- Drug: Xaluritamig
- Drug: Abiraterone
- Drug: Enzalutamide
- Drug: Cabazitaxel
Other Study ID Numbers
- 20230005
- 2024-513968-25
Start Date (Actual)
2024-12-09
Primary Completion Date (Estimated)
2029-01-02
Study Completion Date (Estimated)
2029-07-30
Enrollment (Actual)
707
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Amgen |
| Information Provided By: | Amgen |
| Last Update Posted: | 2026-05-15 |
Study Overview
Brief 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]).
Official Title
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
Conditions
Metastatic Castration-resistant Prostate Cancer
Intervention / Treatment
- Drug: Xaluritamig
- Drug: Abiraterone
- Drug: Enzalutamide
- Drug: Cabazitaxel
Other Study ID Numbers
- 20230005
- 2024-513968-25
Start Date (Actual)
2024-12-09
Primary Completion Date (Estimated)
2029-01-02
Study Completion Date (Estimated)
2029-07-30
Enrollment (Actual)
707
Study Type
Interventional
Phase
Phase 3