Clinical trial NCT04692831: Testing a New Imaging Agent to Identify Cancer
Official title: Imaging of HER2-expressing Cancer With Site-Specifically Labeled 89Zr-ss-Pertuzumab
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: HER-2 Positive Malignant Carcinoma of Breast
HER-2 Protein Overexpression
HER2-positive Metastatic Breast Cancer
Keywords: 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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2021-01-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This protocol will perform a first-in-human imaging trial of 89Zr-ss-pertuzumab.
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: 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)

Primary outcomes:
measure: Evaluate clinical safety of 89Zr-ss-pertuzumab
timeFrame: Up to 20 months
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: PATTY AND GEORGE HOAG CANCER CENTER (Data or Specimen Analysis Only)
state: California
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited protocol activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activites)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Somali Gavane, MD
role: PRINCIPAL_INVESTIGATOR
References: