Clinical Trial 24168

• Overview

  Study Title:

  An Open-Label Phase 1 Safety and Dose Finding Study of Orally Administered Glix1 in Adults with Recurrent or Progressive High-Grade Glioma

  Summary:

  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.

  Objective:

  Primary: -Safety profile of GLIX1 including drug compliance -Recommended Dosage (RD) Secondary: -Pharmacokinetics (PK) of single and repeated dose of GLIX1 -Antitumor response of IMP as monotherapy -Time to progression (TTP) (of disease) -Progression-free survival (PFS) at 6 months

• Treatments

  Therapies:

  Tet methylcytosine dioxygenase 2 Enhancer

  Medications:

  GLIX1 ()

• Inclusion Criteria

  Main Inclusion Criteria:
  • Adult patients aged 18 years or older 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: (a)for nitrosoureas (e.g., lomustine, carmustine, fotemustine): 42 days (6 weeks) (b) for monoclonal antibodies: 42 days (6 weeks) (c) for small molecules, 4 weeks or at least 5 half-lives (whatever is longer)
  • Recovered from all toxicities from prior treatments to Grade 1 or less by NCI CTCAE v6.0:
  • Participants receiving corticosteroids must be on a stable or decreasing dose of ≤6 mg daily dexamethasone (or ≤40 mg prednisone) for the 7 days prior to the start of study treatment.
  • Participants with seizures must be adequately controlled on a stable regimen of anti-epileptic drugs.
  • Adequate performance status: Eastern Cooperative Oncology Group (ECOG) 0 or 1.
  • Ability to swallow tablets or capsules.
  • Adequate hematological, liver and renal function.
  • Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to first dosing. Women must use a highly effective form of contraception (with Pearl Index > Men with partners of childbearing potential must be willing to use condoms in combination with a second effective method of contraception by the partner during the study and for at least 3 months after the last dose of study medication.
  • Other criteria may apply

• Exclusion Criteria

  Main Exclusion Criteria:
  • 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.
  • Receiving any investigational products (defined as treatment for which there is currently no regulatory authority-approved indication) within 4 weeks or 5 half-lives (whichever is the longest) prior to Baseline MRI.
  • Other exclusions may apply

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