89Zr-Trastuzumab PET/CT in Subjects With Previously Treated HER2-Positive Solid Tumors Scheduled to Receive Treatment With MT-5111

Washington University School of Medicine

Overview

This is an open-label, single center, pilot study to assess the feasibility of baseline 89Zr-trastuzumab PET/CT to predict response to treatment with monotherapy MT-5111

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

HER2-positive Solid Tumor HER-2 Positive Cancer

Interventions

89Zr-trastuzumabDRUG

-To minimize uptake of the 89Zr-trastuzumab in normal tissues, immediately prior to planned 89Zr-trastuzumab injection patients will receive a 50 mg dose of "cold" unlabeled trastuzumab intravenously (IV). The administration of a fixed small dose of unlabeled antibody to improve tumor-to-normal-tissue (T/N) uptake of the radiolabeled antibody is standard in this type of imaging procedure.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Must meet eligibility criteria and be registered to receive treatment under Protocol MT-5111\_001 (WU HRPO # 201907092). * Must have at least one measurable lesion by RECIST 1.1 during the dose expansion phase of MT-5111\_001. Osteosarcoma subjects with evaluable (e.g., bone-only) disease may be included. * Must have standard of care 18F-FDG-PET/CT within 90 days before administration of 89Zr-trastuzumab OR be willing to undergo 18F-FDG PET/CT scan for research purposes. * Able to undergo PET/CT imaging * Able to understand and willing to sign an IRB-approved written informed consent document. Exclusion Criteria: * Hepatic only disease * Pregnant or breastfeeding.

Outcomes

Primary Outcomes

Average 89Zr-trastuzumab SUVmax of lesions identified on baseline FDG-PET/CT

-SUVmax is maximum standardized uptake value

Time frame: At baseline

Secondary Outcomes

Average 89Zr-trastuzumab tumor-to-normal tissue uptake ratio of lesions identified on baseline FDG-PET/CT

Time frame: At baseline

Average 89Zr-trastuzumab tumor-to-blood uptake ratio of lesions identified on baseline FDG-PET/CT

Time frame: At baseline

Intra-patient 89Zr-trastuzumab tumor uptake heterogeneity in patients with multiple lesions (fractions of scan-positive and scan-negative lesions)

Time frame: At baseline

Data from ClinicalTrials.gov

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