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

HER2-positive Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04757090
• Other study ID #: 202103039
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 31, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HER-2 Positive Cancer
• HER2-positive Solid Tumor
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Molecular Templates, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average 89Zr-trastuzumab SUVmax of lesions identified on baseline FDG-PET/CT	-SUVmax is maximum standardized uptake value	At baseline
Secondary	Average 89Zr-trastuzumab tumor-to-normal tissue uptake ratio of lesions identified on baseline FDG-PET/CT		At baseline
Secondary	Average 89Zr-trastuzumab tumor-to-blood uptake ratio of lesions identified on baseline FDG-PET/CT		At baseline
Secondary	Intra-patient 89Zr-trastuzumab tumor uptake heterogeneity in patients with multiple lesions (fractions of scan-positive and scan-negative lesions)		At baseline

External Links

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