Actively Recruiting
A Phase 1 Safety and Dose Finding Study of 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
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 6518 years at the time of informed consent
- Histologically confirmed Grade 3 or Grade 4 glioma
- Recurrent or progressive disease
- Up to two prior treatment lines
- At least 3 months since last radiotherapy unless progression is outside prior radiation field
- At least 28 days since last systemic therapy and baseline MRI, with exceptions for nitrosoureas and monoclonal antibodies (42 days) and small molecules (4 weeks or 5 half-lives)
- Recovery from prior treatment toxicities to Grade 1 or less by NCI CTCAE v6.0
- Stable or decreasing corticosteroid dose of 646 mg dexamethasone or 6440 mg prednisone for 7 days before treatment
- Seizures controlled on stable anti-epileptic drugs
- ECOG performance status 0 or 1
- Ability to swallow tablets or capsules
- Adequate blood, liver, and kidney function
- Women of childbearing potential with negative pregnancy test and effective contraception use during study and 3 months after last dose
- Men with partners of childbearing potential willing to use condoms and partner contraception during study and 3 months after last dose
You will not qualify if you...
- Known allergy or contraindication to gadolinium-based contrast used in MRI
- History of another invasive cancer unless in remission for at least 3 years without additional treatment except hormone or bone therapies
- Active or uncontrolled infection or unexplained fever over 386C within 3 days before treatment
- Major surgery or serious injury within 28 days before consenting
- Use of investigational treatments within 4 weeks or 5 half-lives prior to baseline MRI
AI-Screening
AI-Powered Screening
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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
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