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OPALNCT07739017

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

StatusNot Yet Recruiting
PhasePhase 1
Primary completion (estimated)
Track this trial

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: details revised at 1 of 2 entries Show 4 more changesShow less
    • Trial sites expanded: 2 → 6 locations
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 1 of 7 entries
    • Study description expanded, about 4 words
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

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.
Determine MTD/RP2D in TA2 in patients with newly diagnosed MGMT-unmethylated GBM
Timeframe: From first dose of CT-179 through 4 weeks after completion of radiotherapy (up to 12 weeks).

Secondary (7)

Incidence of Adverse Events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Pharmacokinetic parameters Tmax
Overall response rate (ORR)
Progression-Free Survival (PFS)
Pharmacokinetic parameters Cmax
Show 2 moreShow less
Pharmacokinetic parameters T1/2
Pharmacokinetic parameters AUC

Arms and interventions

Treatment Arm 1 (TA1) (recurrent GBM)Experimental

Dose Escalation Study drug CT-179 at multiple dose levels

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

Dose Escalation Study drug CT-179 at two dose levels

Drugs: CT-179

Sites

6 sites in 1 country