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

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

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 Overview

• Status: Withdrawn
• Conditions: HER2-positive Solid Tumor; HER-2 Positive Cancer
• Intervention / Treatment: Drug: 89Zr-trastuzumab

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 89Zr-trastuzumab PET/CT imaging; Enrolled subjects will be asked to undergo 18F-FDG PET/CT imaging (if not performed within the previous 90 days) and 89Zr-trastuzumab PET/CT imaging at baseline prior to the start of monotherapy MT-5111 treatment. Standard of care 18F-FDG PET/CT examinations performed within 90 days of 89Zr-trastuzumab administration can be used in place of a study specific 18F-FDG PET/CT scan. Baseline 89Zr-trastuzumab imaging should be completed no more than 30 days prior to initiating treatment with MT-5111.; Cold trastuzumab and 89Zr-trastuzumab will be administered at Visit 1 and the 89Zr-trastuzumab PET/CT (Visit 2) will take place 4 days (+/-1 day) after administration of 89Zr-trastuzumab.

Drug: 89Zr-trastuzumab; -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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average 89Zr-trastuzumab SUVmax of lesions identified on baseline FDG-PET/CT	-SUVmax is maximum standardized uptake value	At baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Average 89Zr-trastuzumab tumor-to-normal tissue uptake ratio of lesions identified on baseline FDG-PET/CT	At baseline
Average 89Zr-trastuzumab tumor-to-blood uptake ratio of lesions identified on baseline FDG-PET/CT	At baseline
Intra-patient 89Zr-trastuzumab tumor uptake heterogeneity in patients with multiple lesions (fractions of scan-positive and scan-negative lesions)	At baseline

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Molecular Templates, Inc.

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): December 31, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): December 23, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Trastuzumab
• Other Study ID Numbers: 202103039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No