A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naĂŻve Metastatic Castration-resistant Prostate Cancer
A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naĂŻve Metastatic Castration-resistant Prostate Cancer
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).
Inclusion Criteria:
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.
Evidence of progressive disease (PD), defined as 1 or more PCWG3-modified RECIST 1.1 criteria:
Participants must have had prior orchiectomy and/or ongoing androgen-deprivation therapy (ADT) and a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L).
Prior disease progression on 1, and only 1, androgen receptor pathway inhibitor (ARPI) (either enzalutamide, apalutamide, or darolutamide) is required.
Participants intended to receive cabazitaxel must have previously received ≤ 6 cycles of docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Adequate organ function.
Exclusion Criteria:
Disease Related:
Prior/Concomitant Therapy:
Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.
Prior disease progression on or intolerance to abiraterone.
Prior treatment with any chemotherapy regimen in the mCRPC setting and/or > 6 cycles of docetaxel treatment in the mHSPC setting.
Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks before first dose of study treatment with the following exceptions:
Prior radioligand therapy (RLT) within 8 weeks of first dose of study treatment.
Prior radionuclide therapy (radium-223) within 2 months of first dose of study treatment.
Prior palliative radiotherapy within 2 weeks before first dose of study treatment. Participants must have recovered from all radiation-related toxicities.
Concurrent cytotoxic chemotherapy, ARPI, immunotherapy, RLT, poly adenosine diphosphate ribose polymerase (PARP) inhibitor, biological therapy, investigational therapy.
Treatment with live and live-attenuated vaccines within 4 weeks before the first dose of study treatment.
Prior CD3-directed therapy.
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