In short
Clinical trials are studying Xaluritamig in men with metastatic castration-resistant prostate cancer. These studies are looking at whether Xaluritamig can improve survival compared with other treatment choices, and they are also tracking safety and other trial outcomes. The trials are in Phase 3 and focus on people whose cancer has progressed.
Key points
- Clinical trials are studying Xaluritamig in metastatic castration-resistant prostate cancer, a form of prostate cancer that has spread and is still growing despite hormone-lowering treatment. Both studies are Phase 3 trials, which means they compare Xaluritamig with other treatment choices in larger groups of patients. One trial is testing Xaluritamig plus abiraterone in chemotherapy-naïve patients, while the other is testing Xaluritamig against cabazitaxel or a second androgen receptor-directed therapy. The main outcome in both trials is overall survival, so the studies are focused on whether patients live longer. Both trials are authorised and are designed as interventional studies.
Clinical trials overview
Two authorised Phase 3 trials are studying Xaluritamig in metastatic castration-resistant prostate cancer (mCRPC), which means prostate cancer that has spread and is still growing even after hormone-lowering treatment.
Both studies are interventional trials, so the research team assigns the study treatment and compares it with other treatment choices.
Phase 3 study of Xaluritamig plus abiraterone
The first trial, 2025-520555-89-00, is a Phase 3 study in chemotherapy-naïve participants with mCRPC, meaning people have not yet received chemotherapy for this cancer.
This study compares Xaluritamig plus abiraterone with the investigator's choice of docetaxel, cabazitaxel, or abiraterone.
The trial plans to enroll 748 participants and is authorised.
The main goal is to compare overall survival, which means how long people live after starting treatment.
Phase 3 study of Xaluritamig vs cabazitaxel or second androgen receptor-directed therapy
The second trial, NCT06691984, is also a Phase 3 study in people with progressive mCRPC.
This study compares Xaluritamig with investigator's choice, which can be cabazitaxel or a second androgen receptor-directed therapy such as enzalutamide.
The trial plans to enroll 675 participants and is authorised.
The main outcome is also overall survival.
Main endpoints being measured
The main endpoint in both studies is overall survival, which is the standard way to see whether one treatment helps people live longer than another.
Because both trials compare Xaluritamig with other active treatments, they are designed to show whether Xaluritamig can improve outcomes in this advanced prostate cancer setting.
Who may take part
These trials are for people with metastatic castration-resistant prostate cancer.
One of the studies is specifically for people who have not yet had chemotherapy, while the other is for people with progressive disease after prior treatment choices are being considered.
- Chemotherapy-naïve means no chemotherapy has been given yet for this cancer.
- Progressive disease means the cancer is getting worse or growing despite treatment.