The primary objective of the study is to determine the safety and tolerability of 89Zr-DFO-REGN3504. The secondary objectives of the study are: Study Part A only: * To establish adequate mass dose and activity dose of 89Zr˗DFO˗REGN3504 and optimal post-infusion imaging time, as assessed by imaging and blood draw after tracer infusion Study Part B only: * To establish test/re-test reliability of positron emission tomography (PET) measures as assessed on 2 separate tracer infusions at adequate mass dose and optimal imaging time point as determined in Part A * To characterize the pharmacokinetic (PK) profile of 89Zr˗DFO˗REGN3504 based on tracer plasma activity concentration
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
2
89Zr˗DFO˗REGN3504
Regeneron Study Site
New York, New York, United States
Regeneron Study Site
New York, New York, United States
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: Baseline through 90 days after last dose of tracer infusion
Standardized uptake value (SUV) of 89Zr˗DFO˗REGN3504 in the blood pool
Part A
Time frame: Up to day 8
Clinical dosimetry based on the equivalent dose of radiation
Part A
Time frame: Up to day 8
Clinical dosimetry based on the effective dose of radiation
Part A
Time frame: Up to day 8
SUVs across the tumor region of interest (ROIs)
Part A
Time frame: Up to day 8
Maximal SUVs (SUVmax) within tumor ROIs
Part A
Time frame: Up to day 8
Pharmacokinetics (PK) of 89Zr˗DFO˗REGN3504; plasma tracer activity concentration of area under the curve (AUC0-7)
Part A
Time frame: Up to day 8
Change in SUV of 89Zr˗DFO˗REGN3504 in the blood pool
Part B
Time frame: Up to day 36 ± 14 days
Change in SUVs across the tumor ROIs
Part B
Time frame: Up to day 36 ± 14 days
Change in SUVmax within the tumor ROIs
Part B
Time frame: Up to day 36 ± 14 days
Biodistribution of 89Zr˗DFO˗REGN3504
Part B
Time frame: Up to day 36 ± 14 days
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