Tetragon Biosciences Ltd
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.
Glioblastomas (GBMs) are the most common and aggressive primary malignant tumors in adult central nervous system. High-grade glioma almost always recur and/or progress, and upon progression treatment options are very limited with no universal standard therapy established. GLIX1 is a small molecule administered PO (per os, i.e., orally), that targets the deoxyribonucleic acid (DNA) damage repair mechanism by enhancing Tet methylcytosine dioxygenase 2 (TET2) activity. Increasing the activity of the TET2 enzyme increases DNA oxidation at 5-methylcytosine residues. Such oxidation is normally proc…
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 day…
Administered orally, once daily, in cycles of 28 days
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