This is a master protocol designed to evaluate the safety and efficacy of investigational therapies in participants with metastatic castration-resistant prostate cancer (mCRPC).
This is a master protocol designed to evaluate the safety, tolerability, and maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) and efficacy of Acapatamab, in combination with enzalutamide, abiraterone, or the PD1 inhibitor AMG 404, AMG 404 monotherapy, as well as Acapatamab monotherapy, in participants with metastatic castration-resistant prostate cancer (mCRPC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Acapatamab will be administered as an intravenous (IV) infusion.
Enzalutamide will be administered orally.
Abiraterone will be administered orally.
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California at Irvine Medical Center
Orange, California, United States
University of California San Francisco Mission Bay Campus
Dose exploration only: Number of participants who experience dose limiting toxicities (DLTs)
The analysis of all endpoints, unless noted otherwise, will be conducted on the Safety Analysis Set defined as all subjects that are enrolled and receive at least 1 dose of Acapatamab. The analysis of dose-limiting toxicity (DLT) will be conducted on the DLT Analysis Set defined as all subjects that are enrolled and receive at least 1 dose of Acapatamab with an evaluable DLT endpoint. If a single subject experiences more than 1 DLT it will be counted as 1. The DLT endpoint is evaluable if either: 1\) the subject experiences a DLT; or 2) the subject does not experience a DLT after receiving all planned doses within the 28-day DLT window in cycle 1.
Time frame: Up to 3 years
Number of participants who experience one or more treatment-emergent adverse events (TEAEs)
Time frame: Up to 3 years
Number of participants who experience one or more treatment-related adverse events
Time frame: Up to 3 years
Number of participants who experience a clinically significant change in vital signs
Time frame: Up to 3 years
Number of participants who experience a clinically significant change in clinical laboratory tests
Time frame: Up to 3 years
Objective response rate per response evaluation criteria in solid tumors (RECIST) 1.1 with prostate cancer working group 3 (PCWG3) modifications
Time frame: Up to 3 years
Number of participants who experience circulating tumor cell (CTC) response
Time frame: Up to 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AMG 404 will be administered as an intravenous (IV) infusion.
San Francisco, California, United States
University of Chicago
Chicago, Illinois, United States
Norton Cancer Institute
Louisville, Kentucky, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
St Vincents Hospital Sydney
Darlinghurst, New South Wales, Australia
Rigshospitalet
København Ø, Denmark
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
...and 4 more locations
Number of participants who experience prostate-specific antigen (PSA) response rate
Time frame: Up to 3 years
Duration of response
Time frame: Up to 3 years
Overall survival (OS)
Time frame: Up to 3 years
Progression-free survival
Time frame: Up to 3 years
Time to progression
Time frame: Up to 3 years
Time to subsequent therapy
Time frame: Up to 3 years
Maximum plasma concentration (Cmax)
Time frame: Up to 3 years
Minimum plasma concentration (Cmin)
Time frame: Up to 3 years
Area under the concentration-time curve (AUC)
Time frame: Up to 3 years
Accumulation ratio based on area under the concentration-time curve (AUC)
Time frame: Up to 3 years
Half-life (t1/2)
Time frame: Up to 3 years
Change from baseline in prostate-specific membrane antigen (PSMA)-positive tumor burden assessed using gallium (GA) 68-labelled PSMA-11 positron emission tomography/computed tomography (PET/CT)
Time frame: Baseline up to 3 years
Change from baseline in prostate-specific membrane antigen (PSMA)-negative disease burden assessed using 18F-fluorodeoxyglucose (F-FDG) positron emission tomography/computed tomography (PET/CT)
Time frame: Baseline to 3 years
Time to symptomatic skeletal events
Time frame: Up to 3 years
Concentration of alkaline phosphatase
Time frame: Up to 3 years
Concentration of lactate dehydrogenase (LDH)
Time frame: Up to 3 years
Concentration of hemoglobin
Time frame: Up to 3 years
Neutrophil-to-lymphocyte ratio
Time frame: Up to 3 years
Concentration of N-telopeptide in the urine
Time frame: Up to 3 years