New pill takes on aggressive brain tumors in early trial
NCT ID NCT07464925
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This early-stage trial tests an oral drug called GLIX1 in 30 adults with recurrent or progressive high-grade glioma, a fast-growing brain cancer. The study aims to find the safest dose and check for any signs of tumor control. Participants take the drug daily until their disease gets worse or side effects become unacceptable.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GLIX1 (oral capsule)
- What this could lead to
- If it works, this could point toward a new treatment option for people with aggressive brain tumors that have come back after standard therapy.
- What could go wrong
- This is a very early Phase 1 trial with only 30 people. The main goal is safety and dosing, not yet proof of effectiveness. Side effects are unknown and the drug may not shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Main Inclusion Criteria: * 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. Main Exclusion Criteria: * 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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Moffitt Cancer Center
RECRUITINGTampa, Florida, 33612, United States
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NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
Contact Email: •••••@•••••
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Northwestern Medicine
RECRUITINGChicago, Illinois, 60611, United States
Contact Email: •••••@•••••
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