Testing a New Imaging Agent to Identify Cancer

Study Overview
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Brief Summary
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The purpose of this study is to see whether 89Zr-ss-pertuzumab is safe in people with HER2+ cancer.

Official Title
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Imaging of HER2-expressing Cancer With Site-Specifically Labeled 89Zr-ss-Pertuzumab

Conditions
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HER-2 Positive Malignant Carcinoma of Breast, HER-2 Protein Overexpression, HER2-positive Metastatic Breast Cancer

Intervention / Treatment
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* Combination Product: 89Zr-ss-pertuzumab PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy proven HER2-positive or HER2-low primary malignancy or metastatic disease Note: HER2 positivity is defined according to American Society of Clinical Oncology guidelines or ERBB2 amplification on next generation sequencing Note: HER2-low is defined as low HER2 expression, with immunohistochemistry (IHC) 1+ or IHC 2+ and in situ hybridization [ISH]-negative, including FISH. Biopsy proven primary malignancy or metastatic disease At least one malignant lesion on CT, MR, or FDG PET/CT within 60 days of protocol enrollment Age 18 years or greater ECOG performance of 0-2 Exclusion Criteria: Creatinine > 2 times normal limit (obtained with 8 weeks of enrollment) AST/ALT > 2 times normal limit (obtained with 8 weeks of enrollment) Life expectancy < 3 months Pregnancy or lactation Patients who cannot undergo PET/CT due to weight limits (over 450 pounds)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This protocol will perform a first-in-human imaging trial of 89Zr-ss-pertuzumab.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HER2-positive malignancy<br>Participants will have a diagnosis of HER2-positive malignancy | Combination Product: 89Zr-ss-pertuzumab PET/CT<br>* Patients will receive 89Zr-ss-pertuzumab. 89Zr-ss-pertuzumab PET/CT images will be reconstructed using iterative reconstruction and displayed in multiplanar reconstruction. In the event that 89Zr-ss-pertuzumab is unavailable, randomly labelled 89Zr-pertuzumab PET will be allowed to make HER2 PET imaging available for our patients. Once 89Zr-ss-pertuzumab is available, then patients will be imaged with 89Zr-ss-pertuzumab and randomly labelled 89Zr-pertuzumab will no longer be used.<br>|
| Experimental: HER2-low malignancy<br>Participants will have a diagnosis of HER2-low malignancy | Combination Product: 89Zr-ss-pertuzumab PET/CT<br>* Patients will receive 89Zr-ss-pertuzumab. 89Zr-ss-pertuzumab PET/CT images will be reconstructed using iterative reconstruction and displayed in multiplanar reconstruction. In the event that 89Zr-ss-pertuzumab is unavailable, randomly labelled 89Zr-pertuzumab PET will be allowed to make HER2 PET imaging available for our patients. Once 89Zr-ss-pertuzumab is available, then patients will be imaged with 89Zr-ss-pertuzumab and randomly labelled 89Zr-pertuzumab will no longer be used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate clinical safety of 89Zr-ss-pertuzumab | CTCAE Version 5 will be utilized for toxicity evaluation | Up to 20 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HER-2 Positive Malignant Carcinoma of Breast, HER-2 Protein Overexpression, HER2-positive Metastatic Breast Cancer, 3+ HER2 IHC, 2+ HER2 IHC, 20-275, Memorial Sloan Kettering Cancer Center, HER2-positive primary malignancy, Zr-ss-Pertuzumab