Xaluritamig

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.

Table of Contents

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.[1][2]

Both studies are interventional trials, so the research team assigns the study treatment and compares it with other treatment choices.[1][2]

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.[1]

This study compares Xaluritamig plus abiraterone with the investigator’s choice of docetaxel, cabazitaxel, or abiraterone.[1]

The trial plans to enroll 748 participants and is authorised.[1]

The main goal is to compare overall survival, which means how long people live after starting treatment.[1]

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.[2]

This study compares Xaluritamig with investigator’s choice, which can be cabazitaxel or a second androgen receptor-directed therapy such as enzalutamide.[2]

The trial plans to enroll 675 participants and is authorised.[2]

The main outcome is also overall survival.[2]

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.[1][2]

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.[1][2]

Who may take part

These trials are for people with metastatic castration-resistant prostate cancer.[1][2]

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.[1][2]

  • Chemotherapy-naïve means no chemotherapy has been given yet for this cancer.[1]

  • Progressive disease means the cancer is getting worse or growing despite treatment.[2]

Trial ID Phase Condition studied Status Enrollment
2025-520555-89-00 Phase 3 Metastatic castration-resistant prostate cancer Authorised 748
NCT06691984 Phase 3 Metastatic castration-resistant prostate cancer Authorised 675

Ongoing Clinical Trials on Xaluritamig

  • Study of xaluritamig plus abiraterone for men with metastatic castration-resistant prostate cancer who have not received chemotherapy

    Recruiting

    3 1 1 1
    Investigated diseases:
    Austria Belgium France Germany Greece Italy +3
  • Study of xaluritamig compared to cabazitaxel or androgen receptor therapy for patients with metastatic castration-resistant prostate cancer

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Austria Belgium Denmark France Germany Greece +5

Glossary

  • Metastatic: Cancer that has spread from where it started to other parts of the body.
  • Castration-resistant: Cancer that keeps growing even when male hormone levels are lowered.
  • Prostate cancer: Cancer that starts in the prostate, a gland below the bladder in men.
  • Chemotherapy-naïve: A person who has not yet received chemotherapy for the disease being studied.
  • Interventional study: A clinical trial where researchers assign treatments and watch what happens.
  • Phase 3: A later stage of clinical research with more participants, used to compare treatments and measure benefit.
  • Overall survival: The length of time people live after starting a study treatment.
  • Investigator's choice: The treatment selected by the study doctor from the options allowed in the trial.
  • Androgen receptor-directed therapy: A treatment that targets the body's male hormone pathway, which can help control prostate cancer.
  • Abiraterone: A treatment used as one of the comparison options in these trials.
  • Cabazitaxel: A chemotherapy drug used as one of the comparison options in these trials.
  • Docetaxel: A chemotherapy drug used as one of the comparison options in one of the trials.

References