Recruiting
Sponsor ID
20230239

A Study of Xaluritamig Plus Abiraterone Versus Investigator’s Choice in Participants with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer

Sponsor ID
20230239
Clinicaltrials.gov ID
NCT07213674
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objective of this study is to compare overall survival (OS) in participants receiving xaluritamig plus abiraterone against investigator’s choice (docetaxel, cabazitaxel, or abiraterone).

Additional Study Details

Phase
Phase 3
Product
AMG 509
Type
Interventional
Masking
None (Open Label)
Enrollment
750
Additional Study Details

Protocol Summary

Primary Outcome Measures

OS

Timeframe: Up to approximately 51 months

Secondary Outcome Measures

Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), Per Investigator Assessment

Timeframe: Up to approximately 51 months

Objective Response per Modified RECIST 1.1, Per Investigator Assessment

Timeframe: Up to approximately 51 months

Duration of Response (DOR) Per Modified RECIST 1.1, Per Investigator Assessment

Timeframe: Up to approximately 51 months

Disease Control Per Modified RECIST 1.1, Per Investigator Assessment

Timeframe: Up to approximately 51 months

Progression-free Survival (PFS) 2, Per Investigator Assessment

Timeframe: Up to approximately 51 months

Time to Response (TTR), Per Modified RECIST 1.1, Per Investigator Assessment

Timeframe: Up to approximately 51 months

Time to First Subsequent Therapy

Timeframe: Up to approximately 51 months

Time to Symptomatic Skeletal Events (SSE)

Timeframe: Up to approximately 51 months

Number of Participants With Treatment-emergent Adverse events, Treatment-emergent Serious Adverse Events, and Fatal Adverse Events

Timeframe: Up to approximately 51 months

Change From Baseline Over Time at Each Assessment in Brief Pain Inventory - Short Form (BPI-SF) Pain Intensity Scale

Timeframe: Up to approximately 51 months

Change From Baseline Over Time at Each Assessment in BPI-SF Worst Pain Score

Timeframe: Up to approximately 51 months

Change From Baseline Over Time at Each Assessment in BPI-SF Pain Interference Scale

Timeframe: Up to approximately 51 months

Change From Baseline Over Time at Each Assessment in Functional Assessment of Cancer Therapy – Prostate (FACT-P) Total Score and Subscale Scores

Timeframe: Up to approximately 51 months

Change From Baseline Over Time at Each Assessment in European Quality of Life (EuroQol) 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score

Timeframe: Up to approximately 51 months

Change From Baseline Over Time at Each Assessment in the EQ-5D-5L Visual Analogue Scale (VAS)

Timeframe: Up to approximately 51 months

Time to Worsening as Measured by BPI-SF Worst Pain Score

Timeframe: Up to approximately 51 months

Time to Worsening as Measured by BPI-SF Pain Intensity Scale

Timeframe: Up to approximately 51 months

Time to Worsening as Measured by BPI-SF Pain Interference Scale

Timeframe: Up to approximately 51 months

Time to Worsening as Measured by FACT-P Total Score

Timeframe: Up to approximately 51 months

Time to Improvement as Measured by BPI-SF Worst Pain Score in Participants with Moderate/Severe Pain at Baseline

Timeframe: Up to approximately 51 months

Time to Improvement After Worsening as Measured by BPI-SF Pain Intensity Scale Score

Timeframe: Up to approximately 51 months

Time to Improvement After Worsening as Measured by BPI-SF Pain Interference Scale Score

Timeframe: Up to approximately 51 months

Summary Scores Over Time at Each Assessment as Measured by Selected Questions on Symptomatic Adverse Events from the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item Library

Timeframe: Up to approximately 51 months

Summary Scores Over Time at Each Assessment as Measured by the GP5 Question on Overall Bother of Side Effects from the FACT-P Questionnaire

Timeframe: Up to approximately 51 months

Prostate-specific Antigen (PSA) 50 and PSA 90 Responses

Timeframe: Up to approximately 51 months

Time to PSA 50 and PSA 90 Response

Timeframe: Up to approximately 51 months

Duration of PSA 50 and PSA 90 Response

Timeframe: Up to approximately 51 months

Time to PSA Progression

Timeframe: Up to approximately 51 months

Maximum Serum Concentration (Cmax) of Xaluritamig

Timeframe: Up to approximately 51 months

Time to Maximum Concentration (Tmax) of Xaluritamig

Timeframe: Up to approximately 51 months

Minimum Serum Concentration (Cmin) of Xaluritamig

Timeframe: Up to approximately 51 months

Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Xaluritamig

Timeframe: Up to approximately 51 months

Accumulation Ratio of the AUC Over the Dosing Interval for Xaluritamig

Timeframe: Up to approximately 51 months

Half-life (t1/2) of Xaluritamig

Timeframe: Up to approximately 51 months

Abiraterone Serum Concentrations

Timeframe: Up to approximately 51 months

Number of Participants with Formation of Anti-xaluritamig Antibodies

Timeframe: Up to approximately 51 months

Locations

Location
Status
Contact Us
Location
Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Status
Recruiting
Location
City of Hope National Medical Center
Duarte, CA, United States, 91010
Status
Recruiting
Location
Hightower Clinical
Oklahoma City, OK, United States, 73102
Status
Recruiting
Location
City of Hope Orange County Lennar Foundation Cancer Center
Duarte, CA, United States, 91010
Status
Recruiting
Location
Monash Medical Centre
Clayton, VIC, Australia, 3168
Status
Recruiting
Location
Asan Medical Center
Seoul, Republic of Korea, 05505
Status
Recruiting
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