drugset / Trial / NCT01923727

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

NCT01923727

Phase 1/2 Completed 38 enrolled ImaginAb, Inc.
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2013-08
Primary completion
2016-05
Completion
2016-06

Drugs

EvaluationDrugModalityDoseRoute
Subject 89ZR-DF-IAB2M Protein / enzyme biologic 10 mg Intravenous
Subject 89ZR-DF-IAB2M Protein / enzyme biologic 20 mg Intravenous
Subject 89ZR-DF-IAB2M Protein / enzyme biologic 50 mg Intravenous