Actively Recruiting
An Open-Label Phase 1 Safety and Dose Finding Study of Orally Administered GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
Led by Tetragon Biosciences Ltd · Updated on 2026-05-01
30
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating GLIX1, an oral small molecule, in adults with recurrent or progressive high-grade glioma, including glioblastoma. This open-label, multicenter Phase 1 study aims to find the best dose of GLIX1 by assessing safety, tolerability, disease characteristics, pharmacokinetics, and early clinical activity. High-grade gliomas are aggressive brain tumors that often return after standard or investigational treatments, and new therapies are urgently needed. Participants will receive daily doses of GLIX1 capsules, starting at 1000 mg per day, in cycles of 28 days. The study includes a dose-escalation phase to determine the maximal tolerated or recommended dose, followed by dose expansion. Treatment continues until the disease progresses or unacceptable side effects occur. During the study, participants will be closely monitored for treatment-emergent adverse events from the first dose until 30 days after the last dose. Safety profiles and optimal dosing will be evaluated after completing one 28-day treatment cycle. Assessments include disease evaluations and pharmacokinetic profiling. The total participation duration depends on treatment response and tolerability, with follow-up for safety after treatment ends.
CONDITIONS
Brief Title
A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 9 years at the time of informed consent
- Histologically confirmed Grade 3 or Grade 4 glioma
- Recurrent or progressive disease
- No more than two prior treatment lines
- At least 3 months since last day of radiotherapy unless tumor progression outside prior radiation field
- Minimum intervals since last systemic therapy: 28 days generally, 42 days for nitrosoureas and monoclonal antibodies, 4 weeks or 5 half-lives for small molecules
- Recovery from prior treatment toxicities to Grade 1 or less
- Stable or decreasing corticosteroid dose 4 mg dexamethasone or 40 mg prednisone daily for 7 days before study
- Adequately controlled seizures on stable anti-epileptic drugs
- ECOG performance status 0 or 1
- Ability to swallow tablets or capsules
- Adequate blood, liver, and kidney function
- Negative pregnancy test within 7 days before first dose for women of childbearing potential
- Use of highly effective contraception during study and 3 months after for women; men must use condoms plus another effective method during study and 3 months after
You will not qualify if you...
- Known allergy or contraindication to gadolinium-based contrast MRI
- Prior invasive cancer unless complete remission for at least 3 years and no ongoing therapy except hormonal or bone-targeted treatments
- Active or uncontrolled infection, or fever above 386C within 3 days before treatment
- Major surgery or significant trauma within 28 days before consent
- Use of investigational products within 4 weeks or 5 half-lives before baseline MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive escalating doses of GLIX1 taken orally once daily in cycles of 28 days to evaluate safety and dosing.
Visits occur regularly during treatment cycles as per protocol
Duration - 30 days following last dose administration
Participants are monitored for safety and adverse events for 30 days after the last dose of GLIX1.
Approximately 1 to 2 follow-up visits
Trial Site Locations
Total: 3 locations
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Not Yet Recruiting
2
Northwestern Medicine
Chicago, Illinois, United States, 60611
Not Yet Recruiting
3
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here