Title
A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Chemotherapy

Description
A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Chemotherapy

Objective
Primary:
- To compare overall survival (OS) in subjects receiving xaluritamig vs investigator's choice (cabazitaxel or second androgen receptor-directed therapy [ARDT]).

Key Secondary:
- To compare radiographic progression-free survival (rPFS) in subjects receiving xaluritamig vs
investigator's choice (cabazitaxel or second ARDT).

Secondary:
- To evaluate other measures of efficacy of xaluritamig vs investigator's choice (cabazitaxel or second ARDT).
- To compare symptomatic skeletal events (SSE) in subjects treated with xaluritamig vs investigator's choice (cabazitaxel or second ARDT).
- To evaluate the safety and tolerability of xaluritamig vs investigator's choice (cabazitaxel or second ARDT).
- To evaluate health-related quality of life (HRQoL) of xaluritamig vs investigator's choice (cabazitaxel or
second ARDT).
- To evaluate patient-reported safety and tolerability of xaluritamig vs investigator's choice (cabazitaxel or second ARDT).
- Evaluate the biochemical response of xaluritamig vs investigator's choice (cabazitaxel or second ARDT).
- Characterize the pharmacokinetics (PK) of xaluritamig using intensive and sparse PK sampling.
- Evaluate the immunogenicity of xaluritamig.

Treatment The main objective of the study is to compare overall survival in participants receiving xaluritamig versus investigator's choice (cabazitaxel or second androgen receptor-directed therapy [ARDT]).

Key Eligibility For full study eligibility see this study's ClinicalTrials.gov record.

Applicable Disease Sites
Prostate

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital