We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01923727
Recruitment Status : Completed
First Posted : August 16, 2013
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
ImaginAb, Inc.

Tracking Information
First Submitted Date  ICMJE August 13, 2013
First Posted Date  ICMJE August 16, 2013
Last Update Posted Date February 13, 2020
Study Start Date  ICMJE August 2013
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2015)		 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
Original Primary Outcome Measures  ICMJE
 (submitted: August 13, 2013)
  • 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
  • Evaluate biodistribution and PK of [89Zr]Df-IAB2M PET/CT scans for visual detection of metastatic prostate cancer [ Time Frame: Day 1 (Infusion Day) to Day 3 ]
    Imaging, whole body count and blood samples will be used for standard biodistribution and PK analysis.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2013)
  • [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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 13, 2013)		 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Phase I/IIA Study of PET Imaging With 89Zr-Df-IAB2M in Metastatic Prostate Cancer
Official Title  ICMJE A Phase I/IIA Study of PET Imaging With 89Zr-Df-IAb2M in Patients With Metastatic Prostate Cancer
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Metastatic Prostate Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE 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).
Intervention: Biological: [89Zr]Df-IAB2M
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2013)		 38
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01923727
Other Study ID Numbers  ICMJE 002-2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Current Responsible Party ImaginAb, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE ImaginAb, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Neeta Pandit-Taskar, MD Memorial Sloan Kettering Cancer Center
PRS Account ImaginAb, Inc.
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP