89Zr-Trastuzumab PET/CT in Subjects With Previously Treated HER2-Positive Solid Tumors Scheduled to Receive Treatment With MT-5111
NCT04757090 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2021-12-23
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
Interventions
- 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.
Sponsors & Collaborators
-
Molecular Templates, Inc.
collaborator INDUSTRY -
Washington University School of Medicine
lead OTHER
Principal Investigators
-
Brian A Van Tine, M.D., Ph.D. · Washington University School of Medicine
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-31
- Primary Completion
- 2023-12-31
- Completion
- 2023-12-31
- FDA Drug
- Yes
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