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

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ClinicalTrials.gov Identifier: NCT01923727
Recruitment Status : Completed
First Posted : August 16, 2013
Last Update Posted : August 4, 2016
Sponsor:
Information provided by (Responsible Party):
ImaginAb, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Prostate Cancer Radiation: [89Zr]Df-IAB2M Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase I/IIA Study of PET Imaging With 89Zr-Df-IAb2M in Patients With Metastatic Prostate Cancer
Study Start Date : August 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923727


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
ImaginAb, Inc.
Investigators
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Principal Investigator: Neeta Pandit-Taskar, MD Memorial Sloan Kettering Cancer Center

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Responsible Party: ImaginAb, Inc.
ClinicalTrials.gov Identifier: NCT01923727     History of Changes
Other Study ID Numbers: 002-2012
First Posted: August 16, 2013    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by ImaginAb, Inc.:
[89Zr]Df-IAB2M
Prostate
PET Scan

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases