Trial | NCT01923727  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

    Metastatic Prostate Cancer

  • Study Participants

    38
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.
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.
Study Started
Aug 31
2013
Primary Completion
May 31
2016
Study Completion
Jun 30
2016
Last Update
Feb 13
2020

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.

[89Zr]Df-IAB2M Experimental

A single intravenous infusion of 5 mCi of [89Zr]Df-IAB2M in mass doses of either 10 mg, 20 mg or 50 mg (optional).

Criteria 

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
No Results Posted