Recruiting
Sponsor ID
20240361
Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination with Androgen Receptor Pathway Inhibitors in Participants with Metastatic Hormone-sensitive Prostate Cancer
Study Details
The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.
Protocol Summary
Primary Outcome Measures
Number of Participants with Treatment-emergent Adverse Events
Timeframe: Up to approximately 2.5 years
Number of Participants with Treatment-related Adverse Events
Timeframe: Up to approximately 2.5 years
Number of Participants with Clinically Significant Changes in Vital Signs
Timeframe: Up to approximately 2.5 years
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Timeframe: Up to approximately 2.5 years
Secondary Outcome Measures
Percentage of Participants with Prostate-specific Antigen (PSA) < 0.2 ng/mL at 6 Months
Timeframe: 6 months
Time to PSA Progression
Timeframe: Up to approximately 4.5 years
Time to First New Systemic Anticancer Therapy
Timeframe: 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
Timeframe: Up to approximately 4.5 years
Observed Concentration at the End of a Dose Interval of Darolutamide
Timeframe: Up to approximately 4.5 years
Observed Concentration at the End of a Dose Interval of Abiraterone
Timeframe: Up to approximately 4.5 years
Maximum Observed Serum Concentration (Cmax) of Xaluritmag
Timeframe: Up to approximately 4.5 years
Time to Cmax (Tmax) of Xaluritmag
Timeframe: Up to approximately 4.5 years
Area Under the Concentration Time Curve (AUC) of Xaluritmag
Timeframe: Up to approximately 4.5 years
Half-life (t1/2) of Xaluritamig
Timeframe: Up to approximately 4.5 years
Locations
Location
Calvary Mater Newcastle Hospital
Waratah, NSW, Australia, 2298
Status
Recruiting
Location
Kantonsspital Graubuenden
Chur, Switzerland, 7000
Status
Recruiting
Location
University of Minnesota
Minneapolis, MN, United States, 55455
Status
Recruiting
Location
Kantonsspital Sankt Gallen
Sankt Gallen, Switzerland, 9007
Status
Recruiting
Location
Cabrini Hospital
Clayton, VIC, Australia, 3168
Status
Recruiting
Location
The Alfred Hospital
Melbourne, VIC, Australia, 3004
Status
Recruiting
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