Back to resultsPhase I/IIA Study of PET Imaging With 89Zr-Df-IAB2M in Metastatic Prostate Cancer (IAB2M)
Primary Purpose
Metastatic Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[89Zr]Df-IAB2M
Sponsored by
About this trial
This is an interventional diagnostic trial for Metastatic Prostate Cancer focused on measuring [89Zr]Df-IAB2M, Prostate, PET Scan
Eligibility 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
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[89Zr]Df-IAB2M
Arm Description
A single intravenous infusion of 5 mCi of [89Zr]Df-IAB2M in mass doses of either 10 mg, 20 mg or 50 mg (optional).
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
[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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01923727
Brief Title
Phase I/IIA Study of PET Imaging With 89Zr-Df-IAB2M in Metastatic Prostate Cancer
Acronym
IAB2M
Official Title
A Phase I/IIA Study of PET Imaging With 89Zr-Df-IAb2M in Patients With Metastatic Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImaginAb, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Prostate Cancer
Keywords
[89Zr]Df-IAB2M, Prostate, PET Scan
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
[89Zr]Df-IAB2M
Arm Type
Experimental
Arm Description
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 Type
Biological
Intervention Name(s)
[89Zr]Df-IAB2M
Intervention Description
A single intravenous infusion of 5 mCi of [89Zr]Df-IAB2M in a mass dose of 10 mg, 20mg or 50mg.
Primary Outcome Measure Information:
Title
Determine the safety of [89Zr]Df-IAB2M PET in patients with metastatic prostate cancer.
Description
To assess the safety of a single dose of of [89Zr]Df-IAB2M
Time Frame
Day 1 (Infusion Day) through Day 7
Secondary Outcome Measure Information:
Title
[89Zr]Dr-IAB2M PET/CT quantitative assessment of metastatic prostate cancer
Description
To determine the ability of 89Zr-Df-IAb2M PET to detect known sites of disease in patients with metastatic prostate cancer
Time Frame
Day 1 (Infusion Day) to Day 3
Title
Optimal parameters for imaging with [89Zr]Df-IAB2M
Description
To evaluate the mass dose and hours post infusion that provides optimal detection of metastatic prostate cancer
Time Frame
Day 1 (Infusion Day) to Day 3
Title
Sensitivity of [89Zr]Df-IAB2M to detect metastatic prostate cancer
Description
To compare the results of the biopsy and FDG PET scan to the [89Zr]Df-IAB2M images
Time Frame
Up to 4 weeks
Other Pre-specified Outcome Measures:
Title
Determine the radiation dose levels from a single infusion of [89Zr]Df-IAB2M in individuals with metastatic prostate cancer
Description
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.
Time Frame
Day 1 (Infusion Visit) to Day 3
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neeta Pandit-Taskar, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Phase I/IIA Study of PET Imaging With 89Zr-Df-IAB2M in Metastatic Prostate Cancer
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