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

NCT07464925 | Recruiting Phase 1 FDA Drug

• 1 other identifier: GLIX1-C101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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; Glioblastoma; Glioma

Keywords

GLIX1; Glioma; GBM; Glioblastoma; TET2

Outcome Measures

Primary Outcomes (2)

• Safety Profile of GLIX1 (%Participants with Treatment-emergent Adverse Events)

  %Participants with treatment-emergent adverse events (TEAEs) based on CTCAE v6.0

  From first administration of GLIX1 (Cycle 1 Day 1) until 30 days following last dose administration

• 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

  From first administration of GLIX1 (Cycle 1 Day 1) until one cycle of 28 days is complete

Study Arms (1)

GLIX1

EXPERIMENTAL

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

Drug: GLIX1

Interventions

GLIX1 DRUG

Administered orally, once daily, in cycles of 28 days

GLIX1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tetragon Biosciences Ltd: lead

Study Sites (3)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

NOT YET RECRUITING

Northwestern Medicine

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Glioma; Glioblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a first in human, open-label, multicenter dose-escalation study followed by a dose expansion cohort, designed to define the recommended dose of GLIX1 in participants with a high grade glioma that progressed during or recurred after prior treatment. The study will employ the Bayesian Optimal Interval (BOIN) design to guide dose escalation/de-escalation decisions based on Dose Limiting Toxicities.

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 11, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)