Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms

Summary

The primary objective of this Phase 1, open-label, dose-escalation, and exploratory study is to evaluate the safety and tolerability profile (establish the maximum-tolerated dose) and evaluate the occurrence of dose-limiting toxicities (DLTs) following single weekly or multiple-day weekly dose regimens of single-agent, oral ONC206 in patients with recurrent, primary central nervous system (CNS) neoplasms.

Timeline

Start

2020-10-26

Primary completion

2026-07

Completion

2026-12

Publications

• Nguyen TTT, Shang E, Schiffgens S, Torrini C, Shu C, Akman HO, Prabhu VV, Allen JE, Westhoff MA, Karpel-Massler G, Siegelin MD. Induction of Synthetic Lethality by Activation of Mitochondrial ClpP and Inhibition of HDAC1/2 in Glioblastoma. Clin Cancer Res. 2022 May 2;28(9):1881-1895. doi: 10.1158/1078-0432.CCR-21-2857.

Drugs

Indications