A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer
- Registration Number
- NCT04702737
- Lead Sponsor
- Amgen
- Brief Summary
To evaluate the safety and tolerability of Tarlatamab and will determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 41
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: Dose Exploration Tarlatamab The maximum tolerated dose (MTD) will be estimated using isotonic regression (Ji et al, 2010). The recommended phase 2 dose (RP2D) may be identified based on emerging safety data prior to reaching an MTD. Part 2: Dose Expansion Tarlatamab Participants will receive the RP2D/MTD identified in Part 1 (dose exploration) of the study.
- Primary Outcome Measures
Name Time Method Number of Participants who Experience Dose Limiting Toxicities (DLTs) Baseline to 12 months Number of Participants who Experience One or More Treatment-emergent Adverse Events (TEAEs) Day 1 to 12 months Number of Participants who Experience One or More Treatment-related Adverse Events Day 1 to 12 months Number of Participants who Experience a Clinically Significant Change from Baseline in Vital Signs Baseline to 12 months Number of Participants who Experience a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Measurements Baseline to 12 months Number of Participants who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests Baseline to 12 months
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) Baseline to 12 months Progression-free Survival (PFS) Baseline to 12 months Disease Control Rate (DCR) Baseline to 12 months Minimum Serum Concentration (Cmin) of Tarlatamab Baseline to 12 months Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Tarlatamab Baseline to 12 months Maximum Serum Concentration (Cmax) of Tarlatamab Baseline to 12 months Half-life (t1/2) of Tarlatamab Baseline to 12 months Objective Response (OR) Baseline to 12 months OR will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with Prostate Cancer Working Group 3 (PCWG3) modifications.
Overall Survival (OS) Baseline to 12 months Accumulation Ratio of Tarlatamab Baseline to 12 months
Trial Locations
- Locations (21)
Community Health Network MD Anderson Cancer Center - North
🇺🇸Indianapolis, Indiana, United States
Chris OBrien Lifehouse
🇦🇺Camperdown, New South Wales, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
The Ohio State University
🇺🇸Columbus, Ohio, United States
Ordensklinikum Linz Elisabethinen
🇦🇹Linz, Austria
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
Keio University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Landeskrankenhaus Salzburg
🇦🇹Salzburg, Austria
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
Weill Cornell Medical College
🇺🇸New York, New York, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of California at San Francisco Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Medizinische Universitaet Graz
🇦🇹Graz, Austria
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Gustave Roussy
🇫🇷Villejuif Cedex, France
Royal Marsden Hospital
🇬🇧Sutton, United Kingdom
Hospital Clinic i Provincial de Barcelona
🇪🇸Barcelona, Cataluña, Spain