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

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ClinicalTrials.gov Identifier: NCT04757090
Recruitment Status : Not yet recruiting
First Posted : February 16, 2021
Last Update Posted : February 21, 2021
Sponsor:
Collaborator:
Molecular Templates, Inc.
Information provided by (Responsible Party):
Washington University School of Medicine

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

Condition or disease Intervention/treatment Phase
HER2-positive Solid Tumor HER-2 Positive Cancer Drug: 89Zr-trastuzumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Estimated Study Start Date : May 31, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Trastuzumab

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.




Primary Outcome Measures :
  1. Average 89Zr-trastuzumab SUVmax of lesions identified on baseline FDG-PET/CT [ Time Frame: At baseline ]
    -SUVmax is maximum standardized uptake value


Secondary Outcome Measures :
  1. Average 89Zr-trastuzumab tumor-to-normal tissue uptake ratio of lesions identified on baseline FDG-PET/CT [ Time Frame: At baseline ]
  2. Average 89Zr-trastuzumab tumor-to-blood uptake ratio of lesions identified on baseline FDG-PET/CT [ Time Frame: At baseline ]
  3. Intra-patient 89Zr-trastuzumab tumor uptake heterogeneity in patients with multiple lesions (fractions of scan-positive and scan-negative lesions) [ Time Frame: At baseline ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04757090


Contacts
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Contact: Brian A Van Tine, M.D., Ph.D. 314-362-8903 bvantine@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Contact: Brian A Van Tine, M.D., Ph.D.    314-362-8903    bvantine@wustl.edu   
Principal Investigator: Brian A Van Tine, M.D., Ph.D.         
Sub-Investigator: Barry A Siegel, M.D.         
Sub-Investigator: Farrokh Dehdashti, M.D.         
Sub-Investigator: Jingqin (Rosy) Luo, Ph.D.         
Sponsors and Collaborators
Washington University School of Medicine
Molecular Templates, Inc.
Investigators
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Principal Investigator: Brian A Van Tine, M.D., Ph.D. Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04757090    
Other Study ID Numbers: 21-x024
First Posted: February 16, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents