The primary objective of this trial is to determine the safety profile of xaluritamig at the proposed regimen in adult participants with metastatic castration-resistant prostate cancer (mCRPC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Participants will receive xaluritamig via short-term intravenous (IV) infusion.
Rocky Mountain Cancer Centers
Denver, Colorado, United States
RECRUITINGUnited States Oncology Regulatory Affairs Corporate Office
Denver, Colorado, United States
Number of Participants with Treatment-emergent Adverse Events
This will include treatment-emergent adverse events, serious adverse events, treatment-related adverse events, and fatal adverse events.
Time frame: Up to 3.6 Year
Maximum Plasma Concentration (Cmax) of Xaluritamig
Time frame: Up to 1 Year
Time to Cmax (tmax) of Xaluritamig
Time frame: Up to 1 Year
Accumulation Ratio (AR) Following Multiple Doses of Xaluritamig
Time frame: Up to 1 Year
Serum Concentration Before Dosing (Ctrough) of Xaluritamig
Time frame: Up to 1 Year
Area Under the Concentration-time Curve Over the Dosing Interval (AUC) of Xaluritamig
Time frame: Up to 1 Year
Objective Response (OR) per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 3.6 Years
Duration of Response (DOR) per Modified RECIST v1.1
Time frame: Up to 3.6 Years
Disease Control (DC) per Modified RECIST v1.1
Time frame: Up to 3.6 Years
Time to Response (TTR) per Modified RECIST v1.1
Time frame: Up to 3.6 Years
Number of Participants with a Prostate-specific Antigen (PSA) 50 Response
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US Oncology Research Investigational Products Center
Denver, Colorado, United States
RECRUITINGDuke University Medical Center
Durham, North Carolina, United States
RECRUITINGOncology Hematology Care Incorporated
Cincinnati, Ohio, United States
RECRUITINGThomas Jefferson University
Philadelphia, Pennsylvania, United States
RECRUITINGUniversity of Pittsburgh Medical Center Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
RECRUITINGSanford Oncology Clinic and Pharmacy
Sioux Falls, South Dakota, United States
RECRUITINGSarah Cannon Research Institute Oncology Partners
Nashville, Tennessee, United States
RECRUITINGUniversity of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITING...and 4 more locations
Time frame: Up to 3.6 Years
Number of Participants with a PSA 90 Response
Time frame: Up to 3.6 Years
Time to PSA 50 and PSA 90 Response
Time frame: Up to 3.6 Years
Duration of PSA 50 and PSA 90 Response
Time frame: Up to 3.6 Years
Time to PSA Progression
Time frame: Up to 3.6 Years
Time to First Subsequent Therapy
Time frame: Up to 3.6 Years
Radiographic Progression-free Survival (PFS) Per Prostate Cancer Working Group 3 (PCWG3)-modified RECIST 1.1
Time frame: Up to 3.6 Years
Overall Survival (OS)
Time frame: Up to 3.6 Years