Safety Study of VAL-083 and Radiotherapy in Patients With Newly Diagnosed GBM Having Unmethylated MGMT Expression

Summary

The purpose of this Phase 2, open-label, single-arm study is to determine the safety and the maximal tolerated dose (MTD) of VAL-083 in combination with a standard of care radiation regimen when used to treat newly diagnosed GBM in patients with unmethylated promoter of the methylguanine-DNA methyltransferase (uMGMT) gene. Pharmacokinetic (PK) properties will be explored and tumor responses to treatment will be evaluated.

Timeline

Start

2017-12-17

Primary completion

2021-11-22

Completion

2024-12-30

Publications

• Guo C, Yang Q, Deng M, Qiu X, Wu S, Du X, Sai K, Dai Z, Chen Z, Zhang J, Lin F, Ke C, Xi S, Hu W, Zhou Z, Li J, Cao X, Liao Y, Lv Y, Brown D, Langlands J, Johnson G, Bacha J, Kwan C, Kanekal S, Schwartz R, Chen Z. VAL-083 is effective in patients with newly-diagnosed MGMT-unmethylated glioblastoma: report of phase II study. Discov Oncol. 2025 Dec 12;17(1):104. doi: 10.1007/s12672-025-04235-y.

Drugs

Indications