drugset / Trial / NCT01923727
Phase I/IIA Study of PET Imaging With 89Zr-Df-IAB2M in Metastatic Prostate Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |