A Phase 1b, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, and Feasibility of Neoadjuvant Xaluritamig Therapy Prior to Radical Prostatectomy in Subjects With Newly Diagnosed Localized Intermediate or High-Risk Prostate Cancer
Summary
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.
Arms & interventions
- DrugXaluritamig
Intravenous (IV) infusion
- DrugGnRH Antagonist
Oral administration
Outcome measures
Primary
Number 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
Secondary
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
Time 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
Eligibility criteria
Study locations (7)
University of California San Francisco
San Francisco, California, 94143
Washington University
St Louis, Missouri, 63110
The Ohio State University
Columbus, Ohio, 43210
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Fred Hutchinson Cancer Center
Seattle, Washington, 98109-1023
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226