This is a Phase 1 dose-escalation study of PRT811, a protein arginine N-methyltransferase
(PRMT) 5 inhibitor, in subjects with advanced cancers and high-grade gliomas who have
exhausted available treatment options. The purpose of this study is to define a safe dose
and schedule to be used in subsequent development of PRT811.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04089449.
This is a multicenter, open-label, dose-escalation, dose-expansion Phase 1 study of
PRT811, a PRMT5 inhibitor, in subjects with advanced cancers without any approved or
available treatment options including solid tumors, CNS lymphoma, and /or high-grade
gliomas. The study will consist of 2 parts, a dose escalation part evaluating subjects
with advanced solid tumors, CNS lymphoma, and/or high-grade glioma and a cohort expansion
part which will evaluate the safety and efficacy of PRT811 in subjects with advanced
solid tumors, and glioblastoma multiforme. For subjects, the study will include a
screening phase, a treatment phase, and a post treatment follow-up phase. An end-of-study
visit will be conducted within 30 days after the last dose of PRT811.
Lead OrganizationPrelude Therapeutics
