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

Summary

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.

Interventions

• CT-179 · DRUG

  Daily administration of CT-179

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (2)

• Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
• Austin Health, Heidelberg, Victoria, Australia