The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Participants will receive xaluritamig intravenously.
Participants will receive darolutamide orally.
Participants will receive abiraterone orally.
Dana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGUniversity of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGNumber 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
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
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Sarah Cannon Research Institute
Nashville, Tennessee, United States
RECRUITINGChris OBrien Lifehouse
Camperdown, New South Wales, Australia
RECRUITINGCalvary Mater Newcastle Hospital
Waratah, New South Wales, Australia
RECRUITINGCabrini Hospital
Clayton, Victoria, Australia
RECRUITINGPeter MacCallum Cancer Centre
Melbourne, Victoria, Australia
RECRUITINGThe Alfred Hospital
Melbourne, Victoria, Australia
RECRUITINGKantonsspital Graubuenden
Chur, Switzerland
RECRUITINGCentre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
RECRUITING...and 1 more locations
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