Clinical trial NCT01923727: Phase I/IIA Study of PET Imaging With 89Zr-Df-IAB2M in Metastatic Prostate Cancer
Official title: A Phase I/IIA Study of PET Imaging With 89Zr-Df-IAb2M in Patients With Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastatic Prostate Cancer
Keywords: [89Zr]Df-IAB2M
Prostate
PET Scan
Lead sponsor: ImaginAb, Inc.
Sponsor class: INDUSTRY
First posted: 2013-08-16
Enrollment: 38
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Determine the safety of [89Zr]Df-IAB2M PET in patients with metastatic prostate cancer.
timeFrame: Day 1 (Infusion Day) through Day 7
Secondary outcomes:
measure: [89Zr]Dr-IAB2M PET/CT quantitative assessment of metastatic prostate cancer
timeFrame: Day 1 (Infusion Day) to Day 3
measure: Optimal parameters for imaging with [89Zr]Df-IAB2M
timeFrame: Day 1 (Infusion Day) to Day 3
measure: Sensitivity of [89Zr]Df-IAB2M to detect metastatic prostate cancer
timeFrame: Up to 4 weeks
Other outcomes:
measure: Determine the radiation dose levels from a single infusion of [89Zr]Df-IAB2M in individuals with metastatic prostate cancer
timeFrame: Day 1 (Infusion Visit) to Day 3
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Neeta Pandit-Taskar, MD
role: PRINCIPAL_INVESTIGATOR
References: