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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2016

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • Determine the safety of [89Zr]Df-IAB2M PET in patients with metastatic prostate cancer.
    • Time Frame: Day 1 (Infusion Day) through Day 7
    • To assess the safety of a single dose of of [89Zr]Df-IAB2M

Secondary Measures

  • [89Zr]Dr-IAB2M PET/CT quantitative assessment of metastatic prostate cancer
    • Time Frame: Day 1 (Infusion Day) to Day 3
    • To determine the ability of 89Zr-Df-IAb2M PET to detect known sites of disease in patients with metastatic prostate cancer
  • Optimal parameters for imaging with [89Zr]Df-IAB2M
    • Time Frame: Day 1 (Infusion Day) to Day 3
    • To evaluate the mass dose and hours post infusion that provides optimal detection of metastatic prostate cancer
  • Sensitivity of [89Zr]Df-IAB2M to detect metastatic prostate cancer
    • Time Frame: Up to 4 weeks
    • To compare the results of the biopsy and FDG PET scan to the [89Zr]Df-IAB2M images

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ImaginAb, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Neeta Pandit-Taskar, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center

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