Clinical Trial · NCT01923727

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

Overview

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.

Sponsor

Imagine AB, Inc.

Phase

Phase 1/2

Contacts

Neeta Pandit-Taskar, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01923727

Eligibility

Inclusion

Performance status of 60 or higher on Karnofsky scale
Progressive disease manifest (within 6 weeks of screening) by either
Subject's schedule permits compliance with all study procedures
imaging modalities (bone scan, MRI or CT) OR
Patients with histologically confirmed prostate cancer
biochemical progression (PSA)

Exclusion

Renal lab values: Creatinine \> 1.5 ULN
On any new anticancer therapy (GnRH analog allowed) while on the study
Previous anaphylactic reaction to huJ591 antibody or FDG imaging
Other severe acute or chronic medical condition that may increase the risk associated with study participation or investigational product administration
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