Clinical trial · Interventional
OLIG2 Inhibitor CT-179 for Recurrent and Newly-diagnosed Glioblastoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Newly Diagnosed MGMT Unmethylated Glioblastoma | MGMT-Unmethylated Glioblastoma | CURATED_BROADER | 0.78 |
| Recurrent Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT-179 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Arm 1 (TA1) (recurrent GBM)
- description
- Dose Escalation Study drug CT-179 at multiple dose levels
- interventionNames
- Drug: CT-179
- type
- EXPERIMENTAL
- label
- Treatment Arm 2 (TA2) (newly diagnosed MGMT-unmethylated GBM)
- description
- Dose Escalation Study drug CT-179 at two dose levels
- interventionNames
- Drug: CT-179
Primary outcomes (2)
- measure
- Determine Maximum Tolerated Dose (MTD) in TA1 in patients with rGBM
- timeFrame
- From first dose of CT-179 through the end of the 28-day DLT assessment period (Day 28) for each cohort.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available