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Phase 1 Study of GLIX1 for Recurrent High-Grade Glioma

This study is testing a new oral drug called GLIX1 for adults with high-grade glioma (a type of brain cancer) that has come back or gotten worse. The main goal is to find out how safe GLIX1 is and what dose works best. Researchers will also look at how the drug affects the cancer. You might be able to join if you are an adult with Grade 3 or 4 glioma that has recurred or progressed, and you've had no more than two previous treatments. The study is currently recruiting about 30 participants. GLIX1 works by targeting how cancer cells repair their DNA, potentially leading to cancer cell death.

Study design
This is an open-label, multi-center study, meaning both you and your doctors will know you are receiving GLIX1. It will involve about 30 participants and starts by finding the right dose.
What's involved
You will take GLIX1 capsules by mouth once a day in cycles of 28 days. Treatment continues until your disease gets worse or side effects become too much.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from the first dose until 30 days after your last dose of GLIX1.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07464925

A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma

Recruiting
PHASE1Ages 18+InterventionalTreatment
Tetragon Biosciences Ltd
~30 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:GLIX1

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety Profile of GLIX1 (%Participants with Treatment-emergent Adverse Events)
Measured over From first administration of GLIX1 (Cycle 1 Day 1) until 30 days following last dose administration
+1 more outcome measured

Conditions

Glioblastoma Multiforme of Brain
Glioma
Glioblastoma

Explore related trials

Glioma

Where it's being run

3 sites across 3 states
Florida1
Illinois1
New York1

Who to contact

Patrick Grogan, MD
[email protected]
813-745-8000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adult patients aged ≥18 years at the time of informed consent
Participants must have histologically confirmed Grade 3 or Grade 4 glioma
Recurrent or progressive disease
A maximum of two prior treatment lines
Interval of at least 3 months since the last day off of radiotherapy, unless tumor progression and index lesion is outside the prior radiation field.
Interval since last dose of systemic therapy and Baseline MRI of ≥28 days, except:
for nitrosoureas (e.g., lomustine, carmustine, fotemustine): 42 days (6 weeks)
for monoclonal antibodies: 42 days (6 weeks)
for small molecules, 4 weeks or at least 5 half-lives (whatever is longer)
Recovered from all toxicities from prior treatments to Grade 1 or less by NCI CTCAE v6.0:
Participants receiving corticosteroids must be on a stable or decreasing dose of ≤6 mg daily dexamethasone (or ≤40 mg prednisone) for the 7 days prior to the start of study treatment.
Participants with seizures must be adequately controlled on a stable regimen of anti-epileptic drugs.
Adequate performance status: Eastern Cooperative Oncology Group (ECOG) 0 or 1.
Ability to swallow tablets or capsules.
Adequate hematological, liver and renal function.
Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to first dosing. Women must use a highly effective form of contraception (with Pearl Index \<1%) for the duration of the study and for at least 3 months after the last dose of study medication.
Men with partners of childbearing potential must be willing to use condoms in combination with a second effective method of contraception by the partner during the study and for at least 3 months after the last dose of study medication.

Exclusion

Known contraindication for gadolinium (Gd) based, contrast-enhanced MRI
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.
Participants with known active or uncontrolled infection, and/or unexplained fever \>38°C in the 3 days prior to the start of study treatment.
Major non-tumor related surgical procedure or significant traumatic injury within 28 days prior to signing of consent.
Receiving any investigational products (defined as treatment for which there is currently no regulatory authority-approved indication) within 4 weeks or 5 half-lives (whichever is the longest) prior to Baseline MRI.

What this trial measures

  • Safety Profile of GLIX1 (%Participants with Treatment-emergent Adverse Events)From first administration of GLIX1 (Cycle 1 Day 1) until 30 days following last dose administration

    %Participants with treatment-emergent adverse events (TEAEs) based on CTCAE v6.0

  • Maximal Tolerated Dose and/or Recommended DoseFrom first administration of GLIX1 (Cycle 1 Day 1) until one cycle of 28 days is complete

    Maximal Tolerated Dose (MTD) is selected as the dose for which the isotonic estimate of the Dose Limiting Toxicity (DLT) rate is closest to the target rate of 0.3