Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer
Study Details
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.
Protocol Summary
Number of Participants who Experienced Treatment-emergent Adverse Events
Timeframe: Up to 45 months
Number of Participants who Experienced Treatment-related Adverse Events
Timeframe: Up to 28 months
Number of Participants who Received Radical Prostatectomy After Completing Xaluritamig Treatment
Timeframe: Up to 25 months
Number of Participants who Experienced Complications of Radical Prostatectomy According to Clavien-Dindo Classification
Timeframe: Up to 28 months
Change in Prostate-specific Antigen (PSA) Levels from Baseline to End of Xaluritamig Treatment
Timeframe: Up to 25 months
Prostate Imaging-Reporting and Data System (PI-RADS) Score
Timeframe: Up to 25 months
Pathological Complete Response (pCR) Following Radical Prostatectomy
Timeframe: Up to 25 months
Minimal Residual Disease (MRD)
Timeframe: Up to 25 months
Number of Participants who Rise to PSA ≥ 0.2 ng/mL Post-radical Prostatectomy
Timeframe: Up to 45 months
Time to PSA Rise ≥ 0.2 ng/mL Post-radical Prostatectomy
Timeframe: Up to 45 months
Undetectable PSA at SFU
Timeframe: Up to 26 months
PSA Progression-free Survival
Timeframe: Up to 45 months
Maximum Serum Concentration (Cmax) of Xaluritamig
Timeframe: Up to 45 months
Time to Maximum Concentration (Tmax) of Xaluritamig
Timeframe: Up to 45 months
Area Under the Concentration Time Curve (AUC) Over the Dosing Interval
Timeframe: Up to 45 months
Accumulation Following Multiple Dosing
Timeframe: Up to 45 months
Half-life (t1/2) of Xaluritamig
Timeframe: Up to 45 months