Last updated on November 2019

A Study of PRT811 in Participants With Advanced Solid Tumors Gliomas and Myelofibrosis

Brief description of study

This is a Phase 1 dose-escalation study of PRT811, a protein arginine N-methyltransferase (PRMT) 5 inhibitor, in subjects with advanced cancers, high-grade gliomas and myelofibrosis 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.

Detailed Study Description

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 and /or high-grade gliomas, and relapsed/refractory myeloproliferative neoplasms [MPN]. The study will consist of 2 parts, a dose escalation part evaluating subjects with advanced solid tumors 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, glioblastoma multiforme and myelofibrosis. 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.

Clinical Study Identifier: NCT04089449

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