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NCT Number: NCT01923727

Phase I/IIA Study of PET Imaging With 89Zr-Df-IAB2M in 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.

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Key information

Conditions

Metastatic Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[89Zr]Df-IAB2M

Biological

A single intravenous infusion of 5 mCi of [89Zr]Df-IAB2M in a mass dose of 10 mg, 20mg or 50mg.

Primary outcomes

  1. 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 outcomes

  1. [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

  2. 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

  3. 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

Other outcomes

  1. Determine the radiation dose levels from a single infusion of [89Zr]Df-IAB2M in individuals with metastatic prostate cancer

    Time frame: Day 1 (Infusion Visit) to Day 3

    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.

Sponsors and collaborators

Lead sponsor

ImaginAb, Inc.

Industry

Registry information

Official study title

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

Acronym: IAB2M

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 16, 2013
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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