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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Xaluritamig
DrugXaluritamig will be administered IV.
Abiraterone acetate
DrugAbiraterone acetate will be administered orally.
Docetaxel
DrugDocetaxel will be administered IV.
Cabazitaxel
DrugCabazitaxel will be administered IV.
Treatment groups
Trial outcomes
Primary outcomes
OS
Secondary outcomes
Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), Per Investigator Assessment
Objective Response per Modified RECIST 1.1, Per Investigator Assessment
Duration of Response (DOR) Per Modified RECIST 1.1, Per Investigator Assessment
Disease Control Per Modified RECIST 1.1, Per Investigator Assessment