Metastatic Prostate Cancer
Conditions
Keywords
[89Zr]Df-IAB2M, Prostate, PET Scan
Brief summary
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
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.
Interventions
BIOLOGICAL[89Zr]Df-IAB2M
A single intravenous infusion of 5 mCi of \[89Zr\]Df-IAB2M in a mass dose of 10 mg, 20mg or 50mg.
Sponsors
ImaginAb, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the safety of [89Zr]Df-IAB2M PET in patients with metastatic prostate cancer. | Day 1 (Infusion Day) through Day 7 | To assess the safety of a single dose of of \[89Zr\]Df-IAB2M |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| [89Zr]Dr-IAB2M PET/CT quantitative assessment of metastatic prostate cancer | Day 1 (Infusion Day) to Day 3 | To determine the ability of 89Zr-Df-IAb2M PET to detect known sites of disease in patients with metastatic prostate cancer |
| Optimal parameters for imaging with [89Zr]Df-IAB2M | Day 1 (Infusion Day) to Day 3 | To evaluate the mass dose and hours post infusion that provides optimal detection of metastatic prostate cancer |
| Sensitivity of [89Zr]Df-IAB2M to detect metastatic prostate cancer | Up to 4 weeks | To compare the results of the biopsy and FDG PET scan to the \[89Zr\]Df-IAB2M images |
Other
| Measure | Time frame | Description |
|---|---|---|
| Determine the radiation dose levels from a single infusion of [89Zr]Df-IAB2M in individuals with metastatic prostate cancer | Day 1 (Infusion Visit) to Day 3 | Evaluate the biodistribution of \[89Zr\]Df-IAB2M with PET/CT scans, whole body counts and blood samples to determine the radiation dose to organs in individuals with metastatic prostate cancer. |
Countries
United States
Outcome results
None listed