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

NCT ID: NCT01923727

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-06-30

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.

Conditions

Metastatic Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[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).

Group Type: EXPERIMENTAL

[89Zr]Df-IAB2M

Intervention Type: BIOLOGICAL

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

Interventions

[89Zr]Df-IAB2M

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

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

ImaginAb, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neeta Pandit-Taskar, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

002-2012

Identifier Type: -

Identifier Source: org_study_id