A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-gra… (NCT07464925) | Clinical Trial Compass
RecruitingPhase 1
A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
United States30 participantsStarted 2026-04-20
Plain-language summary
This is an open-label, multicenter dose-escalation study to be followed by a dose expansion to define the optimal dose of GLIX1 as monotherapy by reviewing safety and tolerability, disease characteristics and pharmacokinetic profiles and preliminary clinical activity in participants with a high grade diffuse glioma that progressed during or recurred after prior standard of care therapies or investigational therapies as clinically indicated.
Patients will be treated daily with GLIX1 capsules until disease progression or unacceptable safety.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 mon…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety Profile of GLIX1 (%Participants with Treatment-emergent Adverse Events)
Timeframe: From first administration of GLIX1 (Cycle 1 Day 1) until 30 days following last dose administration
2
Maximal Tolerated Dose and/or Recommended Dose
Timeframe: From first administration of GLIX1 (Cycle 1 Day 1) until one cycle of 28 days is complete