OLIG2 Inhibitor CT-179 for Recurrent and Newly-diagnosed Glioblastoma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorOlivia Newton-John Cancer Research Institute
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- CT-179
Treatment groups
54 Participants
are divided into 2 treatment groupsSponsors and collaborators
Olivia Newton-John Cancer Research Institute
Lead sponsor
Curtana Pharmaceuticals, Inc.
Collaborator
Source ClinicalTrials.gov