Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer
- Conditions
- Prostate CancerHigh-risk Biochemical RecurrenceHigh Risk Biochemical Recurrence of Non-metastatic Castration-sensitive Prostate CancerNon-metastatic Castration-sensitive Prostate Cancer
- Interventions
- Registration Number
- NCT06555796
- Lead Sponsor
- Amgen
- Brief Summary
The main objective of this study is to evaluate the safety and tolerability of xaluritamig monotherapy in adult participants with high-risk biochemical recurrent (BCR) nonmetastatic castration-sensitive prostate cancer (nmCSPC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Xaluritamig Xaluritamig Xaluritamig will be administered as a short-term intravenous (IV) infusion for a total of 6 cycles. One treatment cycle consists of 28 days.
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Up to approximately 2 years Events categorized as adverse events (AEs) starting on or after first dose of investigational product (xaluritamig) as determined by the flag indicating if the AE started prior to the first dose on the Events Electronic Case Report Form (eCRF) and including 30 days after the last dose of investigational product (xaluritamig) or end of study date, whichever is earlier.
Number of Participants Experiencing Treatment-related Adverse Events (TRAEs) Up to approximately 2 years A TRAE is any TEAE that per investigators' review has a reasonable possibility of being caused by the investigational product (xaluritamig) determined by the flag indicating an event may have been caused by the investigational product (xaluritamig) on the Events eCRF. In the unlikely event that the flag is missing, the TEAE will be considered related.
- Secondary Outcome Measures
Name Time Method Metastasis-free Survival (MFS) 12, 24, and 36 months Time to Initiation of Androgen Deprivation Therapy or Androgen Receptor Directed Therapy Up to approximately 54 months Time to Prostate-specific Antigen (PSA) Progression Up to 54 months Number of Participants With a PSA 50 Response Up to approximately 54 months Time to Metastatic Disease/Progression Up to approximately 54 months Time to Symptomatic Progression Up to approximately 54 months Time to First Symptomatic Skeletal Event Up to approximately 54 months Time to First use of new Anticancer Therapy Up to approximately 54 months Number of Participants Completing Xaluritamig Monotherapy Treatment Up to approximately 36 months Maximum Serum Concentration (Cmax) of Xaluritamig Up to approximately 19 months Time to Cmax (Tmax) of Xaluritamig Up to approximately 19 months Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Xaluritamig Up to approximately 19 months Terminal Half-life (t1/2) of Xaluritamig Up to approximately 19 months Number of Participants With a PSA 90 Response Up to approximately 54 months Duration of PSA 50 Response Up to approximately 54 months Duration of PSA 90 Response Up to approximately 54 months Number of Participants With Undetectable PSA 6, 12, 24, and 36 months
Trial Locations
- Locations (8)
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
University of Minnesota Medical Center Fairview
🇺🇸Minneapolis, Minnesota, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Chris OBrien Lifehouse
🇦🇺Camperdown, New South Wales, Australia
Cabrini Hospital
🇦🇺Malvern, Victoria, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia