GlioblastomaEarly Phase 1LixuWoONCT07884344
Window of Opportunity Study of Lixumistat in Patients With Newly Diagnosed Glioblastoma
A Early Phase 1 study testing Lixumistat - Cohort 1 and Lixumistat - Cohort 2 in people with Glioblastoma, run by Macarena De La Fuente, MD at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of Lixumistat in patients with newly diagnosed Glioblastoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Lixumistat - Cohort 1 and Lixumistat - Cohort 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be ≥18 years of age.
- Patients with newly-diagnosed Glioblastoma (GBM) for whom neurosurgical tumor resection is indicated and planned according to the assessment of the treating physician as per treating physician or neurosurgeon.
- Patient must have Karnofsky Performance Status (KPS) ≥ 70.
- Magnetic resonance imaging (MRI) scan performed within 21 days prior to starting protocol treatment.
- For women (any individual assigned female at birth) who are not postmenopausal (i.e., < 2 years after last menstruation) or surgically sterile (absence of ovaries and/or uterus) and who are sexually active, agreement to use a highly effective method of contraception during the Treatment Period and for at least 6 months after the last dose of study treatment.
- Male patients (any individual assigned male at birth) of reproductive potential must avoid pregnancy in partners who are women of childbearing potential, and such partners should not consider getting pregnant during the study and for at least 6 months after treatment is discontinued or longer if requested by local authorities. Male patients must not donate semen for 6 months after the last dose of study treatment.
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- Patient understands the procedures and investigational nature of the trial medication and agrees to comply with trial requirements by providing written informed consent.
- Life expectancy ≥ 3 months at the start of treatment in the opinion of the Investigator.
- Patient must have adequate bone marrow function as evidenced by:
- Absolute neutrophil count (ANC) ≥ 1000 cells/µL
- Hemoglobin >8 g/dL (Patients are allowed to be transfused to this level)
- Platelets ≥100 × 109 platelets/L.
- Patient must have adequate hepatic function as evidenced by:
- Serum total bilirubin ≤1.5 × upper limit of normal (ULN), unless considered due to Gilbert's disease or disease involvement following approval by the Lead Principal Investigator
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT))/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase (SGPT)): ≤3 × institutional ULN
- Patient must have adequate renal function as evidenced by:
- Creatinine clearance >30 mL/min (patients with mild or moderate renal impairment) based on the Cockcroft-Gault glomerular filtration rate (GFR) estimation or alternative estimation of renal function, such as Modified Diet in Renal Disease (MDRD) or Chronic Kidney Disease-Epidemiology Collaborative Group (CKD-EPI) equations.
Who cannot join
- Known histological diagnosis of malignant brain tumor other than Glioblastoma (GBM).
- Patients who are unable to undergo contrast-enhanced MRI for any reason (for example, patients with a glomerular filtration rate [GFR] < 30 mL/min, patients with a pacemaker that is incompatible with MRI, have metallic implants that are unable to undergo an MRI, etc.).
- Patients who are receiving any other investigational agents for GBM treatment.
- Received any prior treatment for GBM.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Lixumistat.
- Patients with uncontrolled intercurrent illness.
- Patient on medications with a similar mechanism of action (i.e., oxidative phosphorylation inhibitors) to Lixumistat including the anti-diabetic medication metformin. However, use of anti-diabetic medications with alternative mechanism(s) of action are permitted. NOTE: patients receiving metformin may be eligible to participate if they are transferred to a different anti-diabetic medication and undergo a washout period of 24-hours from last dose of metformin to administration of the first dose of Lixumistat.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Macarena De La Fuente, MD, 305-243-4951, mdelafuente@med.miami.edu
Macarena De La Fuente, MD
About this study
The purpose of this study is to determine the effect of Lixumistat in patients with newly diagnosed Glioblastoma.
- Conditions
- Glioblastoma
- Being tested
- Lixumistat - Cohort 1, Lixumistat - Cohort 2
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lixumistat - Cohort 1Drug
Also called IM156
Participants will receive Lixumistat 400 mg administered orally once daily for up to four days prior to surgery. If the surgical procedure is delayed by up to two days, dosing may continue for a maximum total of six days.
Lixumistat - Cohort 2Drug
Also called IM156
Participants will receive Lixumistat 600 mg administered orally once daily for up to four days prior to surgery. If the surgical procedure is delayed by up to two days, dosing may continue for a maximum total of six days.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Lixumistat 400 mg | Experimental | Participants will receive up to 4 doses (or up to 6 if the participant's date of surgery is delayed by up to 2 days) oral doses of Lixumistat (400 mg per dose), once daily prior to undergoing standard-of-care neurosurgical tumor resection.
Total participation duration is up to 5 months. Receives: Drug: Lixumistat - Cohort 1 |
| Cohort 2 - Lixumistat 600 mg | Experimental | Participants will receive up to 4 doses (or up to 6 if the participant's date of surgery is delayed by up to 2 days) oral doses of Lixumistat (600 mg per dose), once daily prior to undergoing standard-of-care neurosurgical tumor resection.
Total participation duration is up to 5 months. Receives: Drug: Lixumistat - Cohort 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Lixumistat in Brain Tumor Tissue
Total concentration of lixumistat measured in brain tissue homogenate obtained from both contrast-enhancing and non-contrast-enhancing tumor regions. Total concentration of lixumistat in brain tissue homogenate will be reported in nanograms of analyte per milliliter of homogenate buffer, per milligram of tissue (ng/mL/mg).
Measured: Up to 6 months
Secondary outcomes (4)
Pharmacodynamic (PD) Effects of Lixumistat in Brain Tumor Tissue
Pharmacodynamic (PD) effects of Lixumistat will be assessed by evaluating the Lixumistat-induced changes in the expression levels of mitochondrial Protein Complex I in brain tumor tissue obtained from study participants. PD analyses will be performed on tissue samples obtained from both contrast-enhancing and non-contrast-enhancing tumor regions. Lixumistat-induced changes in expression levels of mitochondrial Protein Complex I will be measured using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay from LabCorp. Expression levels of mitochondrial Protein Complex I will be reported as a fold change.
Measured: Up to 6 months
Number of Participants Experiencing Treatment-Related Toxicity: Adverse Events (AEs)
The number of participants experiencing treatment-related adverse events (AEs) after starting protocol therapy will be reported. AEs will be evaluated using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Up to 6 months
Number of Participants Experiencing Treatment-Related Toxicity: Serious Adverse Events (SAEs)
The number of participants experiencing treatment-related toxicity serious adverse events (SAEs) after starting protocol treatment will be reported. SAEs will be evaluated using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Up to 6 months
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
The number of participants experiencing dose-limiting toxicities (DLTs) after starting protocol therapy will be reported. DLTs will be evaluated using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Macarena De La Fuente, MD
- Sponsor type
- University, hospital or other
- Collaborators
- ImmunoMet Therapeutics, Inc.
- Responsible party
- Sponsor-investigator, Macarena De La Fuente, MD, University of Miami
- Investigators
- Macarena De La Fuente, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884344
- Sponsor's protocol ID
- 20260142
- Acronym
- LixuWoO
- Status last verified
- Oct 2026
- First submitted
- 31 Aug 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Window of Opportunity Study of Lixumistat in Patients With Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT07884344
- Acronym / sponsor ID
- LixuWoO / 20260142
- Conditions
- Glioblastoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Macarena De La Fuente, MDUniversity, hospital or other
- Collaborators
- ImmunoMet Therapeutics, Inc.
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of Lixumistat in patients with newly diagnosed Glioblastoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Lixumistat 400 mg | Experimental | Drug: Lixumistat - Cohort 1Participants will receive up to 4 doses (or up to 6 if the participant's date of surgery is delayed by up to 2 days) oral doses of Lixumistat (400 mg per dose), once daily prior to undergoing standard-of-care neurosurgical tumor resection. Total participation duration is up to 5 months. |
| Cohort 2 - Lixumistat 600 mg | Experimental | Drug: Lixumistat - Cohort 2Participants will receive up to 4 doses (or up to 6 if the participant's date of surgery is delayed by up to 2 days) oral doses of Lixumistat (600 mg per dose), once daily prior to undergoing standard-of-care neurosurgical tumor resection. Total participation duration is up to 5 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patient must be ≥18 years of age.
- Patients with newly-diagnosed Glioblastoma (GBM) for whom neurosurgical tumor resection is indicated and planned according to the assessment of the treating physician as per treating physician or neurosurgeon.
- Patient must have Karnofsky Performance Status (KPS) ≥ 70.
- Magnetic resonance imaging (MRI) scan performed within 21 days prior to starting protocol treatment.
- For women (any individual assigned female at birth) who are not postmenopausal (i.e., < 2 years after last menstruation) or surgically sterile (absence of ovaries and/or uterus) and who are sexually active, agreement to use a highly effective method of contraception during the Treatment Period and for at least 6 months after the last dose of study treatment.
Key exclusion criteria (7 listed)
- Known histological diagnosis of malignant brain tumor other than Glioblastoma (GBM).
- Patients who are unable to undergo contrast-enhanced MRI for any reason (for example, patients with a glomerular filtration rate [GFR] < 30 mL/min, patients with a pacemaker that is incompatible with MRI, have metallic implants that are unable to undergo an MRI, etc.).
- Patients who are receiving any other investigational agents for GBM treatment.
- Received any prior treatment for GBM.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Lixumistat.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lixumistat - Cohort 1Also: IM156Participants will receive Lixumistat 400 mg administered orally once daily for up to four days prior to surgery. If the surgical procedure is delayed by up to two days, dosing may continue for a maximum total of six days. | Drug | Cohort 1 - Lixumistat 400 mg |
| Lixumistat - Cohort 2Also: IM156Participants will receive Lixumistat 600 mg administered orally once daily for up to four days prior to surgery. If the surgical procedure is delayed by up to two days, dosing may continue for a maximum total of six days. | Drug | Cohort 2 - Lixumistat 600 mg |
Primary outcome
Concentration of Lixumistat in Brain Tumor Tissue
Time frame: Up to 6 months
Total concentration of lixumistat measured in brain tissue homogenate obtained from both contrast-enhancing and non-contrast-enhancing tumor regions. Total concentration of lixumistat in brain tissue homogenate will be reported in nanograms of analyte per milliliter of homogenate buffer, per milligram of tissue (ng/mL/mg).
4 secondary outcomes
Pharmacodynamic (PD) Effects of Lixumistat in Brain Tumor Tissue
Time frame: Up to 6 months
Number of Participants Experiencing Treatment-Related Toxicity: Adverse Events (AEs)
Time frame: Up to 6 months
Number of Participants Experiencing Treatment-Related Toxicity: Serious Adverse Events (SAEs)
Time frame: Up to 6 months
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Macarena De La Fuente, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lixumistat - Cohort 1 and Lixumistat - Cohort 2 in people with Glioblastoma, run by Macarena De La Fuente, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Macarena De La Fuente, MD (305-243-4951, mdelafuente@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Lixumistat in Brain Tumor Tissue (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.