A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorAmgen

About this trial

The primary objective of this study is to compare overall survival (OS) in participants receiving xaluritamig plus abiraterone against investigator's choice (docetaxel, cabazitaxel, or abiraterone).

Eligibility criteria

Qualifiers

Participant has provided informed consent before initiation of any study-specific activities/procedures.

Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.

Participant must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.

Metastatic castration-resistant prostate cancer (mCRPC) with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained within 28 days before enrollment.

Disqualifiers

Participants with a history of central nervous system (CNS) metastases.

Unresolved toxicities from prior antitumor therapy not having resolved to CTCAE version 5.0 grade 1 or baseline, with the exception of alopecia or toxicities that are stable and well-controlled AND there is an agreement to allow inclusion by both the investigator and the sponsor.

Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.

Prior disease progression on or intolerance to abiraterone.

Trial design

Treatments tested in this trial

  • Xaluritamig
  • Abiraterone acetate
  • Docetaxel
  • Cabazitaxel

Treatment groups

750 Participants
are divided into 2 treatment groups

Sponsors and collaborators