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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| [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 | Day 1 (Infusion Day) to Day 3 |
| Optimal parameters for imaging with [89Zr]Df-IAB2M |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the radiation dose levels from a single infusion of [89Zr]Df-IAB2M in individuals with metastatic prostate cancer | 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. | Day 1 (Infusion Visit) to Day 3 |
Inclusion Criteria:
Adult male >/= 18 years of age
Patients with histologically confirmed prostate cancer
Progressive disease manifest (within 6 weeks of screening) by either
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:
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| Name | Affiliation | Role |
|---|---|---|
| Neeta Pandit-Taskar, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000630605 | 89Zr-Df-IAB2M |
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To evaluate the mass dose and hours post infusion that provides optimal detection of metastatic prostate cancer |
| Day 1 (Infusion Day) to Day 3 |
| 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 | Up to 4 weeks |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |