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

NCT01923727 | Completed Phase 1 FDA Drug

• 1 other identifier: 002-2012
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Prostate Cancer

Keywords

[89Zr]Df-IAB2M; Prostate; PET Scan

Outcome Measures

Primary Outcomes (1)

• 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

  Day 1 (Infusion Day) through Day 7

Secondary Outcomes (3)

• [89Zr]Dr-IAB2M PET/CT quantitative assessment of metastatic prostate cancer

  Day 1 (Infusion Day) to Day 3

• Optimal parameters for imaging with [89Zr]Df-IAB2M

  Day 1 (Infusion Day) to Day 3

• Sensitivity of [89Zr]Df-IAB2M to detect metastatic prostate cancer

  Up to 4 weeks

Other Outcomes (1)

• Determine the radiation dose levels from a single infusion of [89Zr]Df-IAB2M in individuals with metastatic prostate cancer

  Day 1 (Infusion Visit) to Day 3

Study Arms (1)

[89Zr]Df-IAB2M

EXPERIMENTAL

A single intravenous infusion of 5 mCi of \[89Zr\]Df-IAB2M in mass doses of either 10 mg, 20 mg or 50 mg (optional).

Biological: [89Zr]Df-IAB2M

Interventions

[89Zr]Df-IAB2M BIOLOGICAL

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

[89Zr]Df-IAB2M

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ImaginAb, Inc.: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

89Zr-Df-IAB2M

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Neeta Pandit-Taskar, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 16, 2013
• Study Start: August 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 13, 2020

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)