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

Sponsor
Olivia Newton-John Cancer Research Institute
Study ID
NCT07739017
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • CT-179 — DRUG
    Daily administration of CT-179

Study Details

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.

Key Dates

First listed
Jul 31, 2026
Start date
Dec 31, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
54 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm 1 (TA1) (recurrent GBM)
    Dose Escalation Study drug CT-179 at multiple dose levels
  • Experimental: Treatment Arm 2 (TA2) (newly diagnosed MGMT-unmethylated GBM)
    Dose Escalation Study drug CT-179 at two dose levels

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. ]

Central Contacts

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