Recruiting
Sponsor ID
20230237

Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer

Sponsor ID
20230237
Clinicaltrials.gov ID
NCT06613100
EUCTIS ID
2024-511965-13
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
AMG 509
Type
Interventional
Masking
None (Open Label)
Enrollment
40
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations

Location
Status
Contact Us
Location
Universitaetsklinikum Essen
Essen, Germany, 45147
Status
Recruiting
Location
Universitaetsklinikum Hamburg Eppendorf
Hamburg, Germany, 20246
Status
Recruiting
Location
Thomas Jefferson University
Philadelphia, PA, United States, 19107
Status
Recruiting
Location
University of California San Francisco
San Francisco, CA, United States, 94143
Status
Recruiting
Location
Washington University
St Louis, MO, United States, 63110
Status
Recruiting
Location
The Ohio State University
Columbus, OH, United States, 43210
Status
Recruiting
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