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

Completed · Phase 1/Phase 2

Conditions studied: Metastatic Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01923727

Run by

ImaginAb, Inc.

People needed

38

Starts

2013-08-01

Expected to finish

2016-06-01

Last updated by the study team

2020-02-13

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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