Phase 1b Study of Xaluritamig With Darolutamide or Abiraterone for Treating Metastatic Hormone-sensitive Prostate Cancer

What this Trial Is About

Researchers are evaluating the safety and tolerability of xaluritamig when combined with androgen receptor pathway inhibitors, darolutamide or abiraterone, in men with metastatic hormone-sensitive prostate cancer. This phase 1b, open-label study aims to assess how these combinations affect participants with this type of prostate cancer, focusing on treatment-related side effects and vital sign changes. Participants will receive xaluritamig intravenously together with either darolutamide or abiraterone taken orally. These treatments are given in separate study groups, and participants will enter a long-term follow-up period lasting up to three years from their first dose or until they withdraw, are lost to follow-up, or pass away. The study does not include randomization or masking. During the study, participants will have regular evaluations to monitor adverse events, vital signs, and lab tests up to about 2.5 years. Researchers will also measure prostate-specific antigen PSA levels, time to disease progression, and pharmacokinetic data such as drug concentration and half-life over approximately 4.5 years. Safety and treatment effects will be carefully tracked during this period.

Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer