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

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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Prostate Cancer
• Intervention / Treatment: Biological: [89Zr]Df-IAB2M

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [89Zr]Df-IAB2M; A single intravenous infusion of 5 mCi of [89Zr]Df-IAB2M in mass doses of either 10 mg, 20 mg or 50 mg (optional).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
[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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: ImaginAb, Inc.
• Investigators: Principal Investigator: Neeta Pandit-Taskar, MD, Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: August 13, 2013
• First Submitted That Met QC Criteria: August 13, 2013
• First Posted (Estimate): August 16, 2013

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Prostate; PET Scan; [89Zr]Df-IAB2M
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 002-2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No