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

NCT04757090 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 202103039
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

HER2-positive Solid Tumor; HER-2 Positive Cancer

Outcome Measures

Primary Outcomes (1)

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

  -SUVmax is maximum standardized uptake value

  At baseline

Secondary Outcomes (3)

• 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

Study Arms (1)

89Zr-trastuzumab PET/CT imaging

EXPERIMENTAL

* 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

Interventions

89Zr-trastuzumab DRUG

-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.

89Zr-trastuzumab PET/CT imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Hepatic only disease
• Pregnant or breastfeeding.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Molecular Templates, Inc.: collaborator

Related Links

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

MeSH Terms

Interventions

zirconium-89-trastuzumab

Study Officials

• Brian A Van Tine, M.D., Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 16, 2021
• Study Start: December 31, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 23, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share