Oral GLIX1 for Recurrent or Progressive High-grade Glioma
This phase 1 study aims to determine the maximal tolerated dose and safety profile of oral GLIX1 in individuals with recurrent or progressive high-grade glioma, focusing on the percentage of participants experiencing treatment-emergent adverse events.
GLIX1
Astrocytoma+7
+ Glioblastoma
+ Glioma
Treatment Study
Summary
Study start date: March 1, 2026
Actual date on which the first participant was enrolled.This study focuses on a potential treatment for adults with recurrent or progressive high-grade glioma, a type of brain tumor that is aggressive and often comes back or worsens over time. The current treatment options for this condition are limited, making the search for new therapies crucial. The study is investigating a drug called GLIX1, a small molecule that is taken orally. GLIX1 works by enhancing the activity of an enzyme called TET2, which can lead to the death of cancer cells, particularly in high-grade glioma where this enzyme's activity is typically low. The study is designed to find the maximum safe dose of GLIX1 and to understand its safety profile. Participants will take the drug orally, and the study will monitor for any adverse events. The primary outcomes of the study are to determine the maximum tolerated dose of GLIX1 and to evaluate the percentage of participants who experience treatment-emergent adverse events. These results will help researchers understand the safety and potential effectiveness of GLIX1 in treating high-grade glioma.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Northwestern Medicine
Chicago, United StatesNYU Langone Health
New York, United States