NCT01923727

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: ImaginAb, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2013-08-16
• Last updated: 2020-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study