Clinical Trials in Australia / NCT07739017
Starting soon
Phase 1
OLIG2 Inhibitor CT-179 for Recurrent and Newly-diagnosed Glioblastoma
NCT07739017 · tracked via the Priya Life Science Australia tracker
Condition(s) studied
Recurrent GlioblastomaNewly Diagnosed MGMT Unmethylated Glioblastoma
Investigational drug(s) / intervention(s)
CT-179
CT-179: Daily administration of CT-179
Study 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.
Eligibility
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
Primary outcome measure(s)
- Determine Maximum Tolerated Dose (MTD) in TA1 in patients with rGBM — From first dose of CT-179 through the end of the 28-day DLT assessment period (Day 28) for each cohort.
The MTD will be the highest tested dose of CT-179 at which protocol specified number of patients experience a DLT or the MAD at the highest administered dose in the absence of a DLT. - Determine MTD/RP2D in TA2 in patients with newly diagnosed MGMT-unmethylated GBM — From first dose of CT-179 through 4 weeks after completion of radiotherapy (up to 12 weeks).
The MTD will be the highest dose of CT-179 at which protocol specified number of patients experience a DLT or the MAD at the highest administered dose in the absence of a DLT.
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| St Vincent's Hospital | Sydney | New South Wales | |
| Royal North Shore Hospital | Sydney | New South Wales | |
| Princess Alexandra Hospital | Brisbane | Queensland | |
| Royal Brisbane and Women's Hospital | Herston | Queensland | |
| Austin Health | Heidelberg | Victoria | |
| The Alfred Hospital | Melbourne | Victoria |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07739017 on ClinicalTrials.gov ↗ ← All trials in Australia