Phase I/IIA Study of PET Imaging With 89Zr-Df-IAB2M in Metastatic Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase I/IIA Study of PET Imaging With 89Zr-Df-IAb2M in Patients With Metastatic Prostate Cancer

Conditions
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Metastatic Prostate Cancer

Intervention / Treatment
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* Biological: [89Zr]Df-IAB2M


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male >/= 18 years of age Patients with histologically confirmed prostate cancer Progressive disease manifest (within 6 weeks of screening) by either imaging modalities (bone scan, MRI or CT) OR biochemical progression (PSA) Performance status of 60 or higher on Karnofsky scale Subject's schedule permits compliance with all study procedures Ability to understand and willingness to sign a written informed consent form Exclusion Criteria: Previous anaphylactic reaction to huJ591 antibody or FDG imaging On any new anticancer therapy (GnRH analog allowed) while on the study Hepatic lab values: Bilirubin>1.5 ULN; AST/ALT >2.5 ULN; Albumin < 2 g/dL; GGT > 2.5 ULN if Alkaline Phostphatase >2.5 ULN Renal lab values: Creatinine > 1.5 ULN Other severe acute or chronic medical condition that may increase the risk associated with study participation or investigational product administration

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [89Zr]Df-IAB2M<br>A single intravenous infusion of 5 mCi of [89Zr]Df-IAB2M in mass doses of either 10 mg, 20 mg or 50 mg (optional). | Biological: [89Zr]Df-IAB2M<br>* A single intravenous infusion of 5 mCi of [89Zr]Df-IAB2M in a mass dose of 10 mg, 20mg or 50mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Day 1 (Infusion Day) through Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [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 | 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 | 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 | Up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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[89Zr]Df-IAB2M, Prostate, PET Scan