This is a Phase I/IIa study evaluating the safety and feasibility of \[89Zr\]Df-IAB2M as an immunoPET tracer for metastatic prostate cancer. Individuals participating in this study will have a FDG PET scan, as well as four (4) PET scans (over a 3 day period) following the injection of \[89Zr\]Df-IAB2M PET tracer. Three different dosing levels will be explored. The purpose of the study is to demonstrate the safety of \[89Zr\]Df-IAB2M, ability to detect prostate cancer, and optimal time point and dose level for imaging.
IAB2M is an approximately 80 kDA molecular weight antibody fragment (a "Minibody"). Limited (Phase 0/Proof-of-concept) patient experience with this biologic targeting agent has been previously obtained with SPECT imaging Ex-US, demonstrating targeting of soft tissue and bone lesions in advanced metastatic prostate cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
38
A single intravenous infusion of 5 mCi of \[89Zr\]Df-IAB2M in a mass dose of 10 mg, 20mg or 50mg.
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Determine the safety of [89Zr]Df-IAB2M PET in patients with metastatic prostate cancer.
To assess the safety of a single dose of of \[89Zr\]Df-IAB2M
Time frame: Day 1 (Infusion Day) through Day 7
[89Zr]Dr-IAB2M PET/CT quantitative assessment of metastatic prostate cancer
To determine the ability of 89Zr-Df-IAb2M PET to detect known sites of disease in patients with metastatic prostate cancer
Time frame: Day 1 (Infusion Day) to Day 3
Optimal parameters for imaging with [89Zr]Df-IAB2M
To evaluate the mass dose and hours post infusion that provides optimal detection of metastatic prostate cancer
Time frame: Day 1 (Infusion Day) to Day 3
Sensitivity of [89Zr]Df-IAB2M to detect metastatic prostate cancer
To compare the results of the biopsy and FDG PET scan to the \[89Zr\]Df-IAB2M images
Time frame: Up to 4 weeks
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