OLIG2 Inhibitor CT-179 for Recurrent and Newly-diagnosed Glioblastoma

This is a first-in-human Phase 1 two-part, open-label, multi-center, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and maximum tolerated dose (MTD) of CT-179 in patients with recurrent glioblastoma and newly diagnosed MGMT-unmethylated glioblastoma who are eligible to receive radiation therapy following surgery, and to establish the recommended Phase 2 dose.

Inclusion Criteria: * Male or female aged ≥ 18 years at the time of signing informed consent * Supratentorial, histologically confirmed diagnosis of primary GBM that meets the current diagnostic classification: 2021 WHO Classification of Tumors of the Central Nervous System * KPS score ≥ 70 * Adequate organ function * Contraception during study participation, as applicable * Able to swallow tablets Exclusion Criteria: * Treatment with an investigational agent within the last 30 days excluding 5- aminolevulinic acid (5-ALA) * Placement of Gliadel wafers or similar local therapy at time of surgery * Receive bevacizumab * Evidence of intracranial or intra-tumoral hemorrhage * Significant concomitant disorder or serious intercurrent illness * History of prior malignancy, except adequately treated non-melanoma skin cancer, carcinoma in-situ of the cervix, or disease-free for more than 5 years * Treatment for HIV, hepatitis B, or hepatitis C * Any gastrointestinal disorder that could result in reduced absorption of CT-179 * Any psychiatric illness or social situation that would limit compliance with study requirements * Dose of dexamethasone higher than 4 mg/day within 1 week of the first dose of study medication