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Testing a New Imaging Agent to Identify Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04692831
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : September 15, 2022
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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

Condition or disease Intervention/treatment Phase
HER-2 Positive Malignant Carcinoma of Breast HER-2 Protein Overexpression HER2-positive Metastatic Breast Cancer Combination Product: 89Zr-ss-pertuzumab PET/CT Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This protocol will perform a single arm, first-in-human imaging trial of 89Zr-ss-pertuzumab.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Imaging of HER2-positive Cancer With Site-Specifically Labeled 89Zr-ss-Pertuzumab
Actual Study Start Date : November 30, 2020
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Pertuzumab

Arm Intervention/treatment
Experimental: 89Zr-ss-pertuzumab administration
For standard first in-human dosimetry, the first 6-8 patients who receive 89Zr-sspertuzumab will be followed by PET/CT imaging at 3 timepoints: 24 hours post administration (scan 1), 3-4 days post administration (scan 2) and 5-8 days post administration (scan 3). Once the optimal imaging timepoint for 89Zr-ss-pertuzumab is determined from these 6-8 patients, the remaining 12-14 participants will undergo a single timepoint PET/CT at the optimal imaging timepoint.
Combination Product: 89Zr-ss-pertuzumab PET/CT
Patients will receive 89Zr-ss-pertuzumab. 89Zr-ss-pertuzumab PET/CT images will be reconstructed using iterative reconstruction and displayed in multiplanar reconstruction.




Primary Outcome Measures :
  1. Evaluate clinical safety of 89Zr-ss-pertuzumab [ Time Frame: Up to 20 months ]
    CTCAE Version 5 will be utilized for toxicity evaluation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven HER2-positive 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

  • Biopsy proven metastatic disease
  • At least five malignant lesions 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04692831


Contacts
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Contact: Randy Yeh, MD 212-639-3776 yehr@mskcc.org
Contact: Jason Lewis, PhD 646-888-3038 lewisj2@mskcc.org

Locations
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United States, California
PATTY AND GEORGE HOAG CANCER CENTER (Data or Specimen Analysis Only) Not yet recruiting
Newport Beach, California, United States, 92663
Contact: Gary Ulaner, MD, PhD    949-722-6237      
United States, New York
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Randy Yeh, MD    212-639-3776      
Contact: E.         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Randy Yeh, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04692831    
Other Study ID Numbers: 20-275
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: September 15, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
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
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Pertuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents