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

Part of paid clinical trials in Tampa, Florida.

Sponsor
Tetragon Biosciences Ltd
Study ID
NCT07464925
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GLIX1 — DRUG
    Administered orally, once daily, in cycles of 28 days

Study Details

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.

Key Dates

Start date
Apr 20, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

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

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 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Patrick Grogan, MD
[email protected]
813-745-8000
Patrick Grogan, MD (PRINCIPAL_INVESTIGATOR)
Northwestern MedicineChicagoIllinois60611
Ditte Primdahl, MD
312-695-1202
NYU Langone HealthNew YorkNew York10016
Alexandra Miller, MD
[email protected]
(212) 731-6267
Alexandra Miller, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Moffitt Cancer Center· Tampa, FLNorthwestern Medicine· Chicago, ILNYU Langone Health· New York, NY

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