Testing a New Imaging Agent to Identify Cancer
Imaging of HER2-expressing Cancer With Site-Specifically Labeled 89Zr-ss-Pertuzumab
1 other identifier
interventional
60
1 country
8
Brief Summary
The purpose of this study is to see whether 89Zr-ss-pertuzumab is safe in people with HER2+ cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2020
Longer than P75 for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 30, 2020
CompletedFirst Submitted
Initial submission to the registry
December 30, 2020
CompletedFirst Posted
Study publicly available on registry
January 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2026
April 22, 2026
April 1, 2026
6 years
December 30, 2020
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate clinical safety of 89Zr-ss-pertuzumab
CTCAE Version 5 will be utilized for toxicity evaluation
Up to 20 months
Study Arms (2)
HER2-positive malignancy
EXPERIMENTALParticipants will have a diagnosis of HER2-positive malignancy
HER2-low malignancy
EXPERIMENTALParticipants will have a diagnosis of HER2-low malignancy
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
PATTY AND GEORGE HOAG CANCER CENTER (Data or Specimen Analysis Only)
Newport Beach, California, 92663, United States
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553, United States
Related Publications (2)
Yeh R, O'Donoghue JA, Jayaprakasam VS, Mauguen A, Min R, Park S, Brockway JP, Bromberg JF, Zhi WI, Robson ME, Sanford R, Modi S, Agnew BJ, Lyashchenko SK, Lewis JS, Ulaner GA, Zeglis BM. First-in-Human Evaluation of Site-Specifically Labeled 89Zr-Pertuzumab in Patients with HER2-Positive Breast Cancer. J Nucl Med. 2024 Mar 1;65(3):386-393. doi: 10.2967/jnumed.123.266392.
PMID: 38272704DERIVEDZeglis BM, Lewis JS. Click Here for Better Chemistry. N Engl J Med. 2022 Dec 15;387(24):2291-2293. doi: 10.1056/NEJMcibr2213596. Epub 2022 Nov 30. No abstract available.
PMID: 36449446DERIVED
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Somali Gavane, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2020
First Posted
January 5, 2021
Study Start
November 30, 2020
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
November 30, 2026
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.