Status:
WITHDRAWN
89Zr-Trastuzumab PET/CT in Subjects With Previously Treated HER2-Positive Solid Tumors Scheduled to Receive Treatment With MT-5111
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Molecular Templates, Inc.
Conditions:
HER2-positive Solid Tumor
HER-2 Positive Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- Hepatic only disease
- Pregnant or breastfeeding.
Key Trial Info
Start Date :
December 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04757090
Start Date
December 31 2021
End Date
December 31 2023
Last Update
December 23 2021
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