Open label, nonrandomized, dose-escalation trial of MVT-2163 and MVT-5873 used in
performing PET scans. The study is designed to determine the best time and dose of these
agents that result in the best PET image of a tumor. Subjects will be seen on days 1, 2,
4, and 7 for imaging and a clinical assessment. The last study visit is on day 28.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02687230.
This is an open label, nonrandomized, dose-escalation trial of a fixed dose of MVT-2163
and varying antibody masses of MVT-5873. The study is designed to identify an optimal
dose (total antibody mass) and optimal timing, for tumor imaging using PET scanning. This
trial will include a dose escalation and an expansion phase. During the dose escalation
portion of the study, a determination of the optimal time to perform PET imaging will be
made. Following the identification of the "optimal" dose and timing, an 10 additional
subjects will be imaged using the best dose and timing.
In each portion of the study subjects will have a screening visit and, no more than 28
days later, those who are eligible for the study will receive MVT-2163. Each cohort will
have 3-6 subjects. Subjects in cohort 1 will be administered MVT-2163 alone on day 1.
Subjects in cohorts 2 and 3 will receive MVT-5873 on day 1, followed approximately 10
minutes later by MVT-2163. Subjects will return for visits to the clinic on days 2, 4,
and 7 for additional imaging and safety assessments. A follow-up visit will occur on day
28.
The study will also evaluate the tissue distribution and pharmacokinetics of MVT-2163
and, based on these data, the study will estimate the radiation dosimetry of MVT-2163.
Safety assessments will be performed using ECGs, vital signs measurements, assessments of
performance status, and clinical laboratory measurements.
Lead OrganizationBioNTech Research & Development, Inc.
