Recruiting
Sponsor ID
20240361

Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination with Androgen Receptor Pathway Inhibitors in Participants with Metastatic Hormone-sensitive Prostate Cancer

Sponsor ID
20240361
Clinicaltrials.gov ID
NCT07140900
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.

Additional Study Details

Phase
Phase 1
Product
AMG 509
Type
Interventional
Masking
None (Open Label)
Enrollment
60
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants with Treatment-emergent Adverse Events

Timeframe: Up to approximately 2.5 years

Number of Participants with Treatment-related Adverse Events

Timeframe: Up to approximately 2.5 years

Number of Participants with Clinically Significant Changes in Vital Signs

Timeframe: Up to approximately 2.5 years

Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests

Timeframe: Up to approximately 2.5 years

Secondary Outcome Measures

Percentage of Participants with Prostate-specific Antigen (PSA) < 0.2 ng/mL at 6 Months

Timeframe: 6 months

Time to PSA Progression

Timeframe: Up to approximately 4.5 years

Time to First New Systemic Anticancer Therapy

Timeframe: Up to approximately 4.5 years

Time to Radiographic Progression per Prostate Cancer Working Group 3 (PCWG3) Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Timeframe: Up to approximately 4.5 years

Observed Concentration at the End of a Dose Interval of Darolutamide

Timeframe: Up to approximately 4.5 years

Observed Concentration at the End of a Dose Interval of Abiraterone

Timeframe: Up to approximately 4.5 years

Maximum Observed Serum Concentration (Cmax) of Xaluritmag

Timeframe: Up to approximately 4.5 years

Time to Cmax (Tmax) of Xaluritmag

Timeframe: Up to approximately 4.5 years

Area Under the Concentration Time Curve (AUC) of Xaluritmag

Timeframe: Up to approximately 4.5 years

Half-life (t1/2) of Xaluritamig

Timeframe: Up to approximately 4.5 years

Locations

Location
Status
Contact Us
Location
Calvary Mater Newcastle Hospital
Waratah, NSW, Australia, 2298
Status
Recruiting
Location
Kantonsspital Graubuenden
Chur, Switzerland, 7000
Status
Recruiting
Location
University of Minnesota
Minneapolis, MN, United States, 55455
Status
Recruiting
Location
Kantonsspital Sankt Gallen
Sankt Gallen, Switzerland, 9007
Status
Recruiting
Location
Cabrini Hospital
Clayton, VIC, Australia, 3168
Status
Recruiting
Location
The Alfred Hospital
Melbourne, VIC, Australia, 3004
Status
Recruiting
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