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

Metastatic Prostate Cancer Clinical Trial

— IAB2M  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01923727
• Other study ID #: 002-2012
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2013
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: ImaginAb, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
ImaginAb, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Determine the radiation dose levels from a single infusion of [89Zr]Df-IAB2M in individuals with metastatic prostate cancer	Evaluate the biodistribution of [89Zr]Df-IAB2M with PET/CT scans, whole body counts and blood samples to determine the radiation dose to organs in individuals with metastatic prostate cancer.	Day 1 (Infusion Visit) to Day 3
Primary	Determine the safety of [89Zr]Df-IAB2M PET in patients with metastatic prostate cancer.	To assess the safety of a single dose of of [89Zr]Df-IAB2M	Day 1 (Infusion Day) through Day 7
Secondary	[89Zr]Dr-IAB2M PET/CT quantitative assessment of metastatic prostate cancer	To determine the ability of 89Zr-Df-IAb2M PET to detect known sites of disease in patients with metastatic prostate cancer	Day 1 (Infusion Day) to Day 3
Secondary	Optimal parameters for imaging with [89Zr]Df-IAB2M	To evaluate the mass dose and hours post infusion that provides optimal detection of metastatic prostate cancer	Day 1 (Infusion Day) to Day 3
Secondary	Sensitivity of [89Zr]Df-IAB2M to detect metastatic prostate cancer	To compare the results of the biopsy and FDG PET scan to the [89Zr]Df-IAB2M images	Up to 4 weeks