A Phase 1b Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer
Amgen
Summary
The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted. * Participants must have at the time of diagnosis: * De novo mHSPC, defined as metastatic disease with no prior diagnosis of localized prostate cancer AND started androgen deprivation therapy (ADT) (luteinising hormone-releasing hormone \[LHRH\] agonist/antagonist or orchiectomy) with or without androgen receptor pathway inhibitor (ARPI) (defined as abiraterone OR d…
Interventions
- DrugXaluritamig
Participants will receive xaluritamig intravenously.
- DrugDarolutamide
Participants will receive darolutamide orally.
- DrugAbiraterone
Participants will receive abiraterone orally.
Locations (14)
- University of California San FranciscoSan Francisco, California
- Dana Farber Cancer InstituteBoston, Massachusetts
- University of MinnesotaMinneapolis, Minnesota
- Cleveland Clinic FoundationCleveland, Ohio
- Thomas Jefferson UniversityPhiladelphia, Pennsylvania
- Sarah Cannon Research InstituteNashville, Tennessee