GLIX1 for Brain Cancer

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Tetragon Biosciences Ltd

Must be taking: Anti-epileptic drugs

Must not be taking: Investigational products

Disqualifiers: Active infection, Recent surgery, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Until disease progression or unacceptable safety

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called GLIX1, a potential drug for aggressive brain cancer that has returned or worsened after previous treatments. The study aims to determine the best dose of GLIX1 by evaluating its safety, tolerability, and impact on the cancer. Participants will take GLIX1 capsules daily until their condition changes or they experience significant side effects. This trial is suitable for individuals with grade 3 or 4 glioma, who have had two or fewer previous treatments, and are at least three months past their last radiation therapy. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how GLIX1 works in people.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, there are specific time intervals required since your last dose of certain treatments before starting the trial, such as 42 days for nitrosoureas and monoclonal antibodies, and 4 weeks or 5 half-lives for small molecules. You should discuss your current medications with the trial team to understand how they might affect your eligibility.

Is there any evidence suggesting that GLIX1 is likely to be safe for humans?

Research has shown that GLIX1, the treatment under study, shows promise in early tests. It has undergone testing in animals and labs. These tests demonstrated its ability to reach the brain, which is crucial for treating brain cancers like glioblastoma. In animal studies, GLIX1 effectively targeted tumor cells.

Although testing GLIX1 in humans is still in the early stages, researchers are carefully studying it to determine the best dose and monitor safety. The goal is to assess how well people tolerate the treatment and identify any side effects. Previous reports indicated that GLIX1 was safe in animal tests. However, since this is one of the first studies in humans, researchers are focused on understanding its safety and tolerability for people. Participants receive close monitoring to address any side effects promptly. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for brain cancer, which often involve chemotherapy and radiation, GLIX1 takes a different approach by using escalating doses to potentially enhance effectiveness. Researchers are excited about GLIX1 because it introduces a new active ingredient that might target cancer cells more precisely, potentially reducing harm to healthy brain tissue. This innovative approach could offer better outcomes and fewer side effects compared to current treatment options.

What evidence suggests that GLIX1 might be an effective treatment for brain cancer?

Research has shown that GLIX1 yields promising results in early studies for treating gliomas, aggressive brain tumors. In animal tests, GLIX1 effectively reduced tumors and reached the brain, a crucial factor in treating brain cancer. These studies suggest it could shrink tumors effectively. Additionally, GLIX1 proved safe in these early tests. Although more research is needed in humans, these initial findings offer encouragement for prospective participants. The study will administer escalating doses of GLIX1, beginning at 1000 mg/day. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults (18+) with high-grade glioma (Grade 3 or 4) whose brain tumor has come back or gotten worse after up to two previous treatments. Participants must be stable on seizure and steroid medications, and enough time must have passed since their last cancer treatment.

Inclusion Criteria

I am taking 6 mg or less dexamethasone (or 40 mg or less prednisone) daily, and my dose has been stable or decreasing for at least 7 days.

My seizures are well controlled with stable medication.

It has been at least 3 months since my last radiotherapy, unless my tumor grew outside the treated area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive escalating doses of GLIX1 daily until disease progression or unacceptable safety

Until disease progression or unacceptable safety

Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• GLIX1

Trial Overview

The study is testing different doses of a new drug called GLIX1, taken daily as capsules, to find the safest and most effective dose for people with recurrent or progressive high-grade glioma. All participants receive GLIX1; there is no placebo group.

How Is the Trial Designed?

Group I: GLIX1 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Tetragon Biosciences Ltd

Lead Sponsor

Citations

1.

ir.biolinerx.com

ir.biolinerx.com/news-releases/news-release-details/biolinerx-announces-initiation-phase-12a-study-glix1-treatment

BioLineRx Announces Initiation of Phase 1/2a Study ...

In extensive preclinical studies, including in-vivo GBM models, GLIX1 demonstrated potent anti-tumor activity and excellent blood-brain-barrier penetration, ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07464925

NCT07464925 | A Phase 1 Safety and Dose Finding Study ...

Indeed, GLIX1 has been shown to cross the blood brain barrier in rodents and has shown significant activity in various in vitro and in vivo GBM and glioma tumor ...

3.

prnewswire.com

prnewswire.com/il/news-releases/biolinerx-announces-initiation-of-phase-12a-study-of-glix1-for-the-treatment-of-glioblastoma-gbm-302725980.html

BioLineRx Announces Initiation of Phase 1/2a Study ...

In extensive preclinical studies, including in-vivo GBM models, GLIX1 demonstrated potent anti-tumor activity and excellent blood-brain-barrier ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12224736/

Comparative efficacy of glioma treatment strategies - PMC - NIH

Currently, numerous meta-analyses have been conducted to determine the most effective treatment for gliomas, yet no consensus has been reached.

5.

rarecancernews.com

rarecancernews.com/news/first-participant-receives-glix1-early-glioblastoma-clinical-trial/

First participant receives GLIX1 in early glioblastoma ...

The therapy has shown promising antitumor activity, excellent blood-brain-barrier penetration, and a favorable safety profile in preclinical ...

6.

clinicaltrials.med.nyu.edu

clinicaltrials.med.nyu.edu/clinicaltrial/2996/an-open-label-phase-1/

AN OPEN-LABEL PHASE 1 SAFETY AND DOSE FINDING ...

GLIX1 is taken by mouth and works as a TET2 activator. The goal is to find the best dose by looking at safety and side effects, how the disease behaves, how the ...

7.

cordis.europa.eu

cordis.europa.eu/project/id/190184696

Clinical validation of GLIX1: a small molecule that targets ...

Glioblastoma Multiform (GBM) patients usually die 12-18 months after diagnosis, with a 5-year survival rate of 6.8%.