A Phase 1 interventional study of CT-179 in Recurrent Glioblastoma and Newly Diagnosed MGMT Unmethylated Glioblastoma, sponsored by Olivia Newton-John Cancer Research Institute. Not yet recruiting at 6 sites in Australia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Olivia Newton-John Cancer Research Institute · Phase 1, Interventional, and Treatment
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.
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:
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.
2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.
This study's planned enrollment of 54 is above the median of 36 across 1,753 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Olivia Newton-John Cancer Research Institute is the lead sponsor of 14 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose Escalation Study drug CT-179 at multiple dose levels
Drug: CT-179
Dose Escalation Study drug CT-179 at two dose levels
Drug: CT-179
Daily administration of CT-179
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.
Time frame: 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.
Time frame: From first dose of CT-179 through 4 weeks after completion of radiotherapy (up to 12 weeks).
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
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 to maximum concentration (Tmax)
Time frame: 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)
Time frame: 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)
Time frame: From first dose of CT-179 to first documented disease progression, assessed for up to 24 months.
Pharmacokinetic parameters Cmax
Peak Plasma Concentration (Cmax)
Time frame: 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)
Time frame: 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)
Time frame: From first dose of CT-179 through the end of treatment, assessed for up to 24 months.
Effects of CT-179 on tumour metabolism
By fluoroethyl-L-tyrosine-positron emission tomography (FET-PET)
Time frame: Baseline, Day 29 (±7 days), and Day 57 (±7 days).
Determine intra-tumoral drug concentrations
Subset of rGBM patients treated at MTD
Time frame: At the time of surgery following 7-14 days of CT-179 treatment.
Predictive biomarkers of efficacy
OLIG1 and/or OLIG2 tumor expression levels, mutational status of TERT, TP53, EGFR, EGFRvIII, and PTEN
Time frame: From baseline through disease progression or withdrawal, assessed for up to 24 months.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Jun 2028, 18 months later.
Of 240 non-industry phase 1 interventional studies under Glioblastoma, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 76. This study's planned 18 months is below that.
Counting every sponsor, half of 322 studies reached it within 44 months; a quarter within 29 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Olivia Newton-John Cancer Research Institute