NIH Reporter #5R44CA278293-05

Phase 0/I dose escalation trial of MT-125 monotherapy in recurrent high-grade gliomas

This award funds a Phase 0/I clinical trial of MT-125 for recurrent high-grade gliomas, aiming to find the optimal dose and study drug distribution in tumors. It targets glioblastoma using a novel inhibitor and is supported by the National Cancer Institute with FDA orphan drug designation.

Description

The project involves a Phase 0/I dose escalation trial of MT-125 in high-grade gliomas. The project aims to determine the optimal biological dose and assess drug distribution within tumor tissues. It includes a clinical trial with primary endpoints related to dose determination and drug distribution, with secondary endpoints on efficacy and safety. The project focuses on glioblastoma, a highly aggressive brain cancer, and involves a small molecule inhibitor, MT-125, targeting non-muscle myosin II. The project aims to extend survival in glioblastoma models and has received Orphan Drug Designation from the FDA. It is funded by the National Cancer Institute under the NIH and includes collaboration with the Mayo Clinic. The project is part of a SBIR Phase IIB Bridge application and is in the pre-IND stage with positive feedback from the FDA.

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