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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
GLIX1
DrugAdministered orally, once daily, in cycles of 28 days
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: GLIX1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety Profile of GLIX1 (%Participants with Treatment-emergent Adverse Events)
%Participants with treatment-emergent adverse events (TEAEs) based on CTCAE v6.0
Time frame
From first administration of GLIX1 (Cycle 1 Day 1) until 30 days following last dose administration2
Maximal Tolerated Dose and/or Recommended Dose
Maximal Tolerated Dose (MTD) is selected as the dose for which the isotonic estimate of the Dose Limiting Toxicity (DLT) rate is closest to the target rate of 0.3
Time frame
From first administration of GLIX1 (Cycle 1 Day 1) until one cycle of 28 days is completeSponsors and contacts
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Source ClinicalTrials.gov