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Oral GLIX1 for Recurrent or Progressive High-grade Glioma

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Study Aim

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.

What is being tested

GLIX1

Drug
Who is being recruted

Astrocytoma+7

+ Glioblastoma

+ Glioma

Over 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: March 2026
See protocol details

Summary

Principal SponsorTetragon Biosciences Ltd
Last updated: March 21, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleAn Open-Label Phase 1 Safety and Dose Finding Study of Orally Administered GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
Principal SponsorTetragon Biosciences Ltd
Last updated: March 21, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

AstrocytomaGlioblastomaGliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal TumorsNeoplasms, Neuroepithelial

Criteria

5 exclusion criteria prevent from participating
Participants with known active or uncontrolled infection, and/or unexplained fever > 38°C in the 3 days prior to the start of study treatment

Known contraindication for gadolinium (Gd) based, contrast-enhanced MRI

Major non-tumor related surgical procedure or significant traumatic injury within 28 days prior to signing of consent

Prior history of another invasive malignancy unless a complete remission was achieved at least 3 years prior to enrolment AND no additional therapy is required during the study period, except for anti-estrogen or androgen therapy and/or bisphosphonates or denosumab

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Escalating doses of GLIX1, starting at a dose of 1000 mg/day

Study 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

Suspended

Moffitt Cancer Center

Tampa, United StatesOpen Moffitt Cancer Center in Google Maps
Suspended

Northwestern Medicine

Chicago, United States
Suspended

NYU Langone Health

New York, United States
Recruiting soon3 Study Centers