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 (synchronous) mHSPC, defined as metastatic disease with no prior diagnosis of localized prostate cancer, AND started ADT (LHRH agonist/antagonist or orchiectomy) with or without ARPI (defined as abiraterone OR darolutamide) as SOC, first treatment with ADT should be no longer than 12 weeks before screening…
Interventions
- DrugXaluritamig
Participants will receive xaluritamig intravenously.
- DrugDarolutamide
Participants will receive darolutamide orally.
- DrugAbiraterone
Participants will receive abiraterone orally.
Locations (16)
- University of California San FranciscoSan Francisco, California
- Dana Farber Cancer InstituteBoston, Massachusetts
- University of MinnesotaMinneapolis, Minnesota
- Cleveland Clinic FoundationCleveland, Ohio
- Thomas Jefferson UniversityPhiladelphia, Pennsylvania
- University of Pittsburgh Medical Center Hillman Cancer CenterPittsburgh, Pennsylvania