A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma

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.

Trial Details

NCT ID
NCT07464925
Phase
PHASE1
Sponsor
Tetragon Biosciences Ltd
Status
RECRUITING
Cancer Type
Glioblastoma (GBM) Brain Cancer
Interventions
  • GLIX1
Locations (sample)
  • Tampa, Florida, United States|27.94752,-82.45843
  • Chicago, Illinois, United States|41.85003,-87.65005
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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