The main objective of this study is to evaluate the safety and tolerability of xaluritamig monotherapy in adult participants with high-risk biochemical recurrent (BCR) nonmetastatic castration-sensitive prostate cancer (nmCSPC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
IV infusion
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Events categorized as adverse events (AEs) starting on or after first dose of investigational product (xaluritamig) as determined by the flag indicating if the AE started prior to the first dose on the Events Electronic Case Report Form (eCRF) and including 30 days after the last dose of investigational product (xaluritamig) or end of study date, whichever is earlier.
Time frame: Up to approximately 2 years
Number of Participants Experiencing Treatment-related Adverse Events (TRAEs)
A TRAE is any TEAE that per investigators' review has a reasonable possibility of being caused by the investigational product (xaluritamig) determined by the flag indicating an event may have been caused by the investigational product (xaluritamig) on the Events eCRF. In the unlikely event that the flag is missing, the TEAE will be considered related.
Time frame: Up to approximately 2 years
Time to Prostate-specific Antigen (PSA) Progression
Time frame: Up to 50 months
Number of Participants With a PSA 50 Response
Time frame: Up to approximately 50 months
Number of Participants With a PSA 90 Response
Time frame: Up to approximately 50 months
Duration of PSA 50 Response
Time frame: Up to approximately 50 months
Duration of PSA 90 Response
Time frame: Up to approximately 50 months
Number of Participants With Undetectable PSA
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Levine Cancer Institute
Charlotte, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Chris OBrien Lifehouse
Camperdown, New South Wales, Australia
Cabrini Hospital
Malvern, Victoria, Australia
...and 1 more locations
Time frame: Up to approximately 50 months
Time to Initiation of Androgen Deprivation Therapy or Androgen Receptor Directed Therapy
Time frame: Up to approximately 50 months
Time to First use of new Anticancer Therapy
Time frame: Up to approximately 50 months
Time to Metastatic Disease/Progression
Time frame: Up to approximately 50 months
Metastasis-free Survival (MFS)
Time frame: Up to approximately 50 months
Number of Participants Completing Xaluritamig Monotherapy Treatment
Time frame: Up to approximately 24 months
Maximum Serum Concentration (Cmax) of Xaluritamig
Time frame: Up to approximately 24 months
Time to Cmax (Tmax) of Xaluritamig
Time frame: Up to approximately 24 months
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Xaluritamig
Time frame: Up to approximately 24 months
Terminal Half-life (t1/2) of Xaluritamig
Time frame: Up to approximately 24 months