The primary objectives of this study are to evaluate the safety and tolerability of xaluritamig administered as monotherapy or in combination with an oral Gonadotropin-releasing Hormone (GnRH) antagonist in the neoadjuvant setting followed by radical prostatectomy, and to evaluate the feasibility and safety of a radical prostatectomy following xaluritamig administered as monotherapy or in combination with an oral GnRH antagonist in the neoadjuvant setting.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Intravenous (IV) infusion
Oral administration
University of California San Francisco
San Francisco, California, United States
RECRUITINGWashington University
St Louis, Missouri, United States
RECRUITINGNumber of Participants who Experienced Treatment-emergent Adverse Events
Inclusive of adverse events, serious adverse events, and changes in vital signs and clinical laboratory tests.
Time frame: Up to 45 months
Number of Participants who Experienced Treatment-related Adverse Events
Time frame: Up to 28 months
Number of Participants who Received Radical Prostatectomy After Completing Xaluritamig Treatment
Time frame: Up to 25 months
Number of Participants who Experienced Complications of Radical Prostatectomy According to Clavien-Dindo Classification
Time frame: Up to 28 months
Change in Prostate-specific Antigen (PSA) Levels from Baseline to End of Xaluritamig Treatment
Time frame: Up to 25 months
Prostate Imaging-Reporting and Data System (PI-RADS) Score
Time frame: Up to 25 months
Pathological Complete Response (pCR) Following Radical Prostatectomy
Time frame: Up to 25 months
Minimal Residual Disease (MRD)
Time frame: Up to 25 months
Number of Participants who Rise to PSA ≥ 0.2 ng/mL Post-radical Prostatectomy
Time frame: Up to 45 months
Time to PSA Rise ≥ 0.2 ng/mL Post-radical Prostatectomy
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The Ohio State University
Columbus, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
RECRUITINGCarolina Urologic Research Center
Myrtle Beach, South Carolina, United States
RECRUITINGFred Hutchinson Cancer Center
Seattle, Washington, United States
RECRUITINGMedical College of Wisconsin
Milwaukee, Wisconsin, United States
RECRUITINGUniversitaetsklinikum Essen
Essen, Germany
RECRUITINGUniversitaetsklinikum Hamburg Eppendorf
Hamburg, Germany
RECRUITINGTime frame: Up to 45 months
Undetectable PSA at SFU
Time frame: Up to 26 months
PSA Progression-free Survival
Time frame: Up to 45 months
Maximum Serum Concentration (Cmax) of Xaluritamig
Time frame: Up to 45 months
Time to Maximum Concentration (Tmax) of Xaluritamig
Time frame: Up to 45 months
Area Under the Concentration Time Curve (AUC) Over the Dosing Interval
Time frame: Up to 45 months
Accumulation Following Multiple Dosing
Time frame: Up to 45 months
Half-life (t1/2) of Xaluritamig
Time frame: Up to 45 months