Recurrent GlioblastomaPhase 1OPALNCT07739017
OLIG2 Inhibitor CT-179 for Recurrent and Newly-diagnosed Glioblastoma
A Phase 1 study testing CT-179 in people with Recurrent Glioblastoma and Newly Diagnosed MGMT Unmethylated Glioblastoma, run by Olivia Newton-John Cancer Research Institute at 6 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent Glioblastoma, Newly Diagnosed MGMT Unmethylated Glioblastoma
- What is being tested?
- CT-179
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 6 sitesAustralia
- Study dates
- Dec 2026to Sep 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Australia6 sites
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Dr Katharine Cuff
Austin Health
Heidelberg, Victoria, 3084
Prof Hui Gan
Royal Brisbane and Women's Hospital
Herston, Queensland, 4006
Prof Zarnie Lwin
The Alfred Hospital
Melbourne, Victoria, 3004
Dr. Malaka Ameratunga
St Vincent's Hospital
Sydney, New South Wales, 2010
Dr Joe Wei
Royal North Shore Hospital
Sydney, New South Wales, 2065
A/Prof Hao-Wen Sim
About this study
Official title: A Phase 1, Two-Part, Accelerated Dose Titration Trial of CT-179 as Monotherapy in the Treatment of Recurrent Glioblastoma and in Combination With Radiation Therapy in the Treatment of Newly Diagnosed MGMT-Unmethylated 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.
Read the detailed description
The OPAL trial is a Phase 1, multi-center, open-label study designed to evaluate the safety and tolerability of CT-179. CT-179 is an orally administered small molecule that modulates the oligodendrocyte transcription factor 2 (OLIG2). The study will enroll up to 54 adult patients with isocitrate dehydrogenase (IDH)-wild type Glioblastoma (GBM).
To evaluate the drug across different stages of the disease, the trial is structured into distinct treatment groups:
- Treatment Arm 1 (Recurrent GBM): In Treatment Arm 1, patients will receive a daily oral dose of CT-179 for a 28-day Dose-Limiting Toxicity (DLT) assessment period. Dose escalation begins at 0.65 mg/kg and may proceed up to 10.4 mg/kg across six planned cohorts. The first three cohorts will use an Accelerated Titration design (one patient per cohort) before reverting to a standard 3+3 dose-escalation design if specific moderate or dose-limiting toxicities are observed.
- Treatment Arm 2 (Newly Diagnosed MGMT-Unmethylated GBM):
Enrollment in Arm 2 will only begin after the sixth cohort in Arm 1 successfully clears its 28-day DLT period. These patients will receive CT-179 for a one-week lead-in, followed by six weeks of CT-179 administered concurrently with standard radiation therapy (60 Gy). The DLT observation period for this arm lasts up to 12 weeks and uses a standard 3+3 dose-escalation design.
- Intra-Tumoral Drug Concentration (IDC) Sub-Study: Once the Maximum Tolerated Dose (MTD) is established in Arm 1, a sub-study will evaluate how well CT-179 penetrates tumor tissue. Patients will receive CT-179 for 7 to 14 days before their scheduled tumor resection so that intra-tumoral drug concentrations can be measured from the resected tissue.
- Study Objectives: The primary objective across all cohorts is to determine the MTD and the Recommended Phase 2 Dose (RP2D) for CT-179. Secondary and exploratory measures include tracking pharmacokinetics (PK), assessing preliminary efficacy via Overall Response Rate (ORR) and Progression-Free Survival (PFS) using RANO 2.0 criteria, and evaluating changes in tumor metabolism via FET-PET imaging.
- Being tested
- CT-179
- Keywords
- Glioblastoma, Brain Tumour, OLIG2
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-179Drug
Daily administration of CT-179
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 1 (TA1) (recurrent GBM) | Experimental | Dose Escalation Study drug CT-179 at multiple dose levels Receives: Drug: CT-179 |
| Treatment Arm 2 (TA2) (newly diagnosed MGMT-unmethylated GBM) | Experimental | Dose Escalation Study drug CT-179 at two dose levels Receives: Drug: CT-179 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Rate of patients reporting adverse events or serious adverse events
Measured: 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
Time to maximum concentration (Tmax)
Measured: From first dose of CT-179 through the end of treatment, assessed for up to 24 months.
Overall response rate (ORR)
Per RANO 2.0 (Response Assessment in Neuro-Oncology)
Measured: From first dose of CT-179 until documented disease progression or withdrawal, assessed for up to 24 months.
Progression-Free Survival (PFS)
Per RANO 2.0 (Response Assessment in Neuro-Oncology)
Measured: From first dose of CT-179 to first documented disease progression, assessed for up to 24 months.
Pharmacokinetic parameters Cmax
Peak Plasma Concentration (Cmax)
Measured: From first dose of CT-179 through the end of treatment, assessed for up to 24 months.
Pharmacokinetic parameters T1/2
Terminal elimination half-life (T1/2)
Measured: From first dose of CT-179 through the end of treatment, assessed for up to 24 months.
Pharmacokinetic parameters AUC
Area under the plasma concentration versus time curve (AUC)
Measured: From first dose of CT-179 through the end of treatment, assessed for up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1 dose escalation cohorts
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olivia Newton-John Cancer Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Curtana Pharmaceuticals, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739017
- Sponsor's protocol ID
- CT-179-102
- Acronym
- OPAL
- Status last verified
- Oct 2026
- First submitted
- 29 Apr 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Two-Part, Accelerated Dose Titration Trial of CT-179 as Monotherapy in the Treatment of Recurrent Glioblastoma and in Combination With Radiation Therapy in the Treatment of Newly Diagnosed MGMT-Unmethylated Glioblastoma
- ClinicalTrials.gov ID
- NCT07739017
- Acronym / sponsor ID
- OPAL / CT-179-102
- Keywords
- Glioblastoma, Brain Tumour, OLIG2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Olivia Newton-John Cancer Research InstituteUniversity, hospital or other
- Collaborators
- Curtana Pharmaceuticals, Inc.
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The OPAL trial is a Phase 1, multi-center, open-label study designed to evaluate the safety and tolerability of CT-179. CT-179 is an orally administered small molecule that modulates the oligodendrocyte transcription factor 2 (OLIG2). The study will enroll up to 54 adult patients with isocitrate dehydrogenase (IDH)-wild type Glioblastoma (GBM).
To evaluate the drug across different stages of the disease, the trial is structured into distinct treatment groups:
- Treatment Arm 1 (Recurrent GBM): In Treatment Arm 1, patients will receive a daily oral dose of CT-179 for a 28-day Dose-Limiting Toxicity (DLT) assessment period. Dose escalation begins at 0.65 mg/kg and may proceed up to 10.4 mg/kg across six planned cohorts. The first three cohorts will use an Accelerated Titration design (one patient per cohort) before reverting to a standard 3+3 dose-escalation design if specific moderate or dose-limiting toxicities are observed.
- Treatment Arm 2 (Newly Diagnosed MGMT-Unmethylated GBM):
Enrollment in Arm 2 will only begin after the sixth cohort in Arm 1 successfully clears its 28-day DLT period. These patients will receive CT-179 for a one-week lead-in, followed by six weeks of CT-179 administered concurrently with standard radiation therapy (60 Gy). The DLT observation period for this arm lasts up to 12 weeks and uses a standard 3+3 dose-escalation design.
- Intra-Tumoral Drug Concentration (IDC) Sub-Study: Once the Maximum Tolerated Dose (MTD) is established in Arm 1, a sub-study will evaluate how well CT-179 penetrates tumor tissue. Patients will receive CT-179 for 7 to 14 days before their scheduled tumor resection so that intra-tumoral drug concentrations can be measured from the resected tissue.
- Study Objectives: The primary objective across all cohorts is to determine the MTD and the Recommended Phase 2 Dose (RP2D) for CT-179. Secondary and exploratory measures include tracking pharmacokinetics (PK), assessing preliminary efficacy via Overall Response Rate (ORR) and Progression-Free Survival (PFS) using RANO 2.0 criteria, and evaluating changes in tumor metabolism via FET-PET imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1 dose escalation cohorts
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm 1 (TA1) (recurrent GBM) | Experimental | Drug: CT-179Dose Escalation Study drug CT-179 at multiple dose levels |
| Treatment Arm 2 (TA2) (newly diagnosed MGMT-unmethylated GBM) | Experimental | Drug: CT-179Dose Escalation Study drug CT-179 at two dose levels |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-179Daily administration of CT-179 | Drug | Treatment Arm 1 (TA1) (recurrent GBM), Treatment Arm 2 (TA2) (newly diagnosed MGMT-unmethylated GBM) |
Primary outcome
Determine Maximum Tolerated Dose (MTD) in TA1 in patients with rGBM
Time frame: 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
Time frame: 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.
7 secondary outcomes
Incidence of Adverse Events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Time frame: 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
Time frame: From first dose of CT-179 through the end of treatment, assessed for up to 24 months.
Overall response rate (ORR)
Time frame: From first dose of CT-179 until documented disease progression or withdrawal, assessed for up to 24 months.
Progression-Free Survival (PFS)
Time frame: From first dose of CT-179 to first documented disease progression, assessed for up to 24 months.
Pharmacokinetic parameters Cmax
Time frame: From first dose of CT-179 through the end of treatment, assessed for up to 24 months.
Pharmacokinetic parameters T1/2
Time frame: From first dose of CT-179 through the end of treatment, assessed for up to 24 months.
Pharmacokinetic parameters AUC
Time frame: From first dose of CT-179 through the end of treatment, assessed for up to 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CT-179 in people with Recurrent Glioblastoma and Newly Diagnosed MGMT Unmethylated Glioblastoma, run by Olivia Newton-John Cancer Research Institute at 6 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Romano (+61 3 9496 3573, opal@onjcri.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine Maximum Tolerated Dose (MTD) in TA1 in patients with rGBM (time frame: From first dose of CT-179 through the end of the 28-day DLT assessment period (Day 28) for each cohort.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.