NYU Langone Health
This is an open-label, first-in-human phase 1 and surgical window of opportunity study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of CM93 in subjects with recurrent glioblastoma (rGBM) characterized by Epidermal Growth Factor Receptor (EGFR) amplification/mutation who have previously received at least 1st-line high-grade glioma therapy.
The study will be conducted in 2 consecutive parts - Part 1: Dose Escalation and Dose Expansion Part 2: Window-of-Opportunity Surgical Study Part 1 of the study will consist of a Dose Escalation and a Dose Expansion Phase. The Dose Escalation Phase will employ a Bayesian Optimal Interval (BOIN) dose escalation design to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and ecommended Phase 2 dose(s) (RP2D). The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of the study subjects. Part 2 of the study is a surgical window o…
Inclusion Criteria: 1. Have histologically confirmed recurrent or progressive World Health Organization grade 4 isocitrate dehydrogenase (IDH) wild type glioblastoma (WHO grade 4). 2. Archival tumor from initial or other prior surgery is documented to have epidermal growth factor receptor (EGFR) mutation or EGFR amplification, as detected by an FDA-approved test or CLIA-approved laboratory- developed test. For enrollment in the surgical window-of-opportunity study (Part 2), patients should have recurrent glioblastoma characterized by EGFR mutation or amplification who are candidates for surgi…
Administered orally as a single daily dose.
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