Recruiting
Phase 1

GLIX1

Sponsor:

Tetragon Biosciences Ltd

Code:

NCT07464925

Conditions

Glioblastoma Multiforme of Brain

Glioma

Glioblastoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GLIX1

Study Details

Brief 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.

Patients will be treated daily with GLIX1 capsules until disease progression or unacceptable safety.

Conditions

Glioblastoma Multiforme of Brain

Glioma

Glioblastoma

Study ID

NCT07464925

Start date

Apr 20, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 days (6 weeks)
  • 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 <1%) for the duration of the study and for at least 3 months after the last dose of study medication.
  • 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.

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: GLIX1

Escalating doses of GLIX1, starting at a dose of 1000 mg/day

Interventions

GLIX1

Administered orally, once daily, in cycles of 28 days

Primary outcome measure

  • Safety Profile of GLIX1 (%Participants with Treatment-emergent Adverse Events) [ Time Frame: From first administration of GLIX1 (Cycle 1 Day 1) until 30 days following last dose administration ]
  • Maximal Tolerated Dose and/or Recommended Dose [ Time Frame: From first administration of GLIX1 (Cycle 1 Day 1) until one cycle of 28 days is complete ]

Central Contacts and Locations

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Patrick Grogan, MD

813-745-8000Patrick.grogan@moffitt.org

Principal Investigator:

Patrick Grogan, MD

Northwestern Medicine

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Ditte Primdahl, MD

312-695-1202cancer@northwestern.edu

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Alexandra Miller, MD

(212) 731-6267cancertrials@nyulangone.org

Principal Investigator:

Alexandra Miller, MD, PhD

More Information

Sponsor

Tetragon Biosciences Ltd

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

  • GLIX1
  • Glioma
  • GBM
  • Glioblastoma
  • TET2

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Tetragon Biosciences Ltd on 2026-07-30.