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Tests treatment safety and results for Glioblastoma Multiforme of Brain
Official title A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
ClinicalTrials.gov ID: NCT07464925
What this study is testing
What is GLIX1?
GLIX1 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for glioblastoma multiforme of brain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Main
- 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
You likely can't join 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...
- 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...
See the full eligibility criteria
- Main
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Chicago, Illinois, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; Chicago, Illinois, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.