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

NCT07739017 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CT-179-102
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Recurrent Glioblastoma; Newly Diagnosed MGMT Unmethylated Glioblastoma

Keywords

Glioblastoma; Brain Tumour; OLIG2

Outcome Measures

Primary Outcomes (2)

• Determine Maximum Tolerated Dose (MTD) in TA1 in patients with rGBM

  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.

  From first dose of CT-179 through the end of the 28-day DLT assessment period (Day 28) for each cohort.

• Determine MTD/RP2D in TA2 in patients with newly diagnosed MGMT-unmethylated GBM

  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.

  From first dose of CT-179 through 4 weeks after completion of radiotherapy (up to 12 weeks).

Secondary Outcomes (7)

• Incidence of Adverse Events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

  From first dose of CT-179 through 28 days after the last dose of study treatment, assessed for up to 24 months.

• Pharmacokinetic parameters Tmax

  From first dose of CT-179 through the end of treatment, assessed for up to 24 months.

• Overall response rate (ORR)

  From first dose of CT-179 until documented disease progression or withdrawal, assessed for up to 24 months.

• Progression-Free Survival (PFS)

  From first dose of CT-179 to first documented disease progression, assessed for up to 24 months.

• Pharmacokinetic parameters Cmax

  From first dose of CT-179 through the end of treatment, assessed for up to 24 months.

Other Outcomes (3)

• Effects of CT-179 on tumour metabolism

  Baseline, Day 29 (±7 days), and Day 57 (±7 days).

• Determine intra-tumoral drug concentrations

  At the time of surgery following 7-14 days of CT-179 treatment.

• Predictive biomarkers of efficacy

  From baseline through disease progression or withdrawal, assessed for up to 24 months.

Study Arms (2)

Treatment Arm 1 (TA1) (recurrent GBM)

EXPERIMENTAL

Dose Escalation Study drug CT-179 at multiple dose levels

Drug: CT-179

Treatment Arm 2 (TA2) (newly diagnosed MGMT-unmethylated GBM)

EXPERIMENTAL

Dose Escalation Study drug CT-179 at two dose levels

Drug: CT-179

Interventions

CT-179 DRUG

Daily administration of CT-179

Treatment Arm 1 (TA1) (recurrent GBM); Treatment Arm 2 (TA2) (newly diagnosed MGMT-unmethylated GBM)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Olivia Newton-John Cancer Research Institute: lead
• Curtana Pharmaceuticals, Inc.: collaborator

Study Sites (2)

Royal Brisbane and Women's Hospital

Herston, Queensland, 4006, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Alexandra Romano

CONTACT

+61 3 9496 3573; opal@onjcri.org.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase 1 dose escalation cohorts

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

AU (2)