This phase II trial assesses the feasibility of using a type of imaging called 89Zr-trastuzumab PET/CT to predict response to treatment with MT-5111 in patients with HER2-positive solid tumors. Positron emission tomography (PET) scans allows imaging of the function of different cells and organs in the body. Computed tomography (CT) scans are a type of x-ray scan that image the anatomy of the body. The combined PET/CT scanner is a special type of scanner that allows imaging of both structure (CT) and function (PET) following the injection of a radioactive material – in this case, 89Zr-trastuzumab and fludeoxyglucose F-18 (18F-FDG). Diagnostic procedures, such as 89Zr-trastuzumab PET/CT and 18-FDG PET/CT, may help in learning how well MT-5111 works to kill HER2-positive tumors cells and allow doctors to plan better treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04757090.
PRIMARY OBJECTIVE:
I. Determine whether the degree of zirconium Zr 89 trastuzumab (89Zr-trastuzumab) tumor uptake and intra-patient heterogeneity of 89Zr-trastuzumab tumor uptake before initiation of therapy with engineered toxin body targeting HER2 MT-5111 (MT-5111) (baseline) can distinguish patients who have clinical benefit (complete response, partial response or stable disease) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, from MT-5111 therapy from those who do not.
SECONDARY OBJECTIVE:
I. Determine whether the 89Zr-trastuzumab tumor uptake and intra-patient heterogeneity of 89Zr-trastuzumab tumor uptake before initiation of therapy with MT-5111 are predictive of progression-free survival (PFS) in patients undergoing treatment with MT-5111.
EXPLORATORY OBJECTIVE:
I. Correlate the degree of 89Zr-trastuzumab tumor uptake with the level of circulating sHER2 at baseline.
OUTLINE:
Patients who have not undergone 18F-FDG PET/CT in in the past 90 days, receive fludeoxyglucose F-18 intravenously (IV) and undergo PET/CT over 15-25 minutes at baseline (before MT-5111 treatment). All patients receive trastuzumab IV and zirconium Zr 89 trastuzumab IV at baseline. Beginning 3 days after receiving zirconium Zr 89 trastuzumab, patients undergo PET/CT over 40-60 minutes.
After completion of study intervention, patients are followed up for 30 days.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorBrian Andrew Van Tine
