A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTetragon Biosciences Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- GLIX1
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
3Moffitt Cancer Center33612, TampaFlorida, United States
Northwestern Medicine60611, ChicagoIllinois, United States
NYU Langone Health10016, New YorkNew York, United States
Sponsors and collaborators
Tetragon Biosciences Ltd
Lead sponsor
Source ClinicalTrials.gov