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
Summary
The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.
Arms & interventions
- DrugXaluritamig
Participants will receive xaluritamig intravenously.
- DrugDarolutamide
Participants will receive darolutamide orally.
- DrugAbiraterone
Participants will receive abiraterone orally.
Outcome measures
Primary
Number of Participants with Treatment-emergent Adverse Events
Time frame: Up to approximately 2.5 years
Number of Participants with Treatment-related Adverse Events
Time frame: Up to approximately 2.5 years
Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to approximately 2.5 years
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Time frame: Up to approximately 2.5 years
Secondary
Percentage of Participants with Prostate-specific Antigen (PSA) < 0.2 ng/mL at 6 Months
Time frame: 6 months
Time to PSA Progression
Time frame: Up to approximately 4.5 years
Time to First New Systemic Anticancer Therapy
Time frame: Up to approximately 4.5 years
Time to Radiographic Progression per Prostate Cancer Working Group 3 (PCWG3) Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: Up to approximately 4.5 years
Observed Concentration at the End of a Dose Interval of Darolutamide
Time frame: Up to approximately 4.5 years
Observed Concentration at the End of a Dose Interval of Abiraterone
Time frame: Up to approximately 4.5 years
Maximum Observed Serum Concentration (Cmax) of Xaluritmag
Time frame: Up to approximately 4.5 years
Time to Cmax (Tmax) of Xaluritmag
Time frame: Up to approximately 4.5 years
Area Under the Concentration Time Curve (AUC) of Xaluritmag
Time frame: Up to approximately 4.5 years
Half-life (t1/2) of Xaluritamig
Time frame: Up to approximately 4.5 years
Eligibility criteria
Study locations (6)
University of California San Francisco
San Francisco, California, 94158
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
University of Minnesota
Minneapolis, Minnesota, 55455
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Sarah Cannon Research Institute
Nashville, Tennessee, 37203