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RecruitingNCT07884344LixuWoOUpdated Oct 20, 2026

Window of Opportunity Study of Lixumistat in Patients With Newly Diagnosed Glioblastoma

An Early Phase 1 interventional study of Lixumistat - Cohort 1 and Lixumistat - Cohort 2 in Glioblastoma, sponsored by Macarena De La Fuente, MD. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Macarena De La Fuente, MD · Early Phase 1, Interventional, and Treatment

Updated Oct 20, 2026Newly registeredGo to Updates ↓
Phase
Early Phase 1
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine the effect of Lixumistat in patients with newly diagnosed Glioblastoma.

02

Conditions studied

  • Glioblastoma

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03

In context

Glioblastoma

1,951 studies on the registry are indexed under Glioblastoma; 457 are open to participants now.

This study's planned enrollment of 10 is below the median of 36 across 1,645 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Macarena De La Fuente, MD is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patient must be ≥18 years of age.
  2. 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.
  3. Patient must have Karnofsky Performance Status (KPS) ≥ 70.
  4. Magnetic resonance imaging (MRI) scan performed within 21 days prior to starting protocol treatment.
  5. 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.
  6. 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.
  7. Patient understands the procedures and investigational nature of the trial medication and agrees to comply with trial requirements by providing written informed consent.
  8. Life expectancy ≥ 3 months at the start of treatment in the opinion of the Investigator.

  9. Patient must have adequate bone marrow function as evidenced by:

    1. Absolute neutrophil count (ANC) ≥ 1000 cells/µL
    2. Hemoglobin >8 g/dL (Patients are allowed to be transfused to this level)
    3. Platelets ≥100 × 109 platelets/L.

  10. Patient must have adequate hepatic function as evidenced by:

    1. 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
    2. Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT))/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase (SGPT)): ≤3 × institutional ULN

  11. Patient must have adequate renal function as evidenced by:

    1. 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.

Exclusion criteria

Exclusion Criteria:

  1. Known histological diagnosis of malignant brain tumor other than Glioblastoma (GBM).
  2. 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.).
  3. Patients who are receiving any other investigational agents for GBM treatment.
  4. Received any prior treatment for GBM.
  5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Lixumistat.
  6. Patients with uncontrolled intercurrent illness.
  7. 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.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Cohort 1 - Lixumistat 400 mg

    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.

    Drug: Lixumistat - Cohort 1

  • Experimental
    Cohort 2 - Lixumistat 600 mg

    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.

    Drug: Lixumistat - Cohort 2

Interventions

  • DrugLixumistat - Cohort 1

    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.

    Also known as: IM156

  • DrugLixumistat - Cohort 2

    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.

    Also known as: IM156

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Up to 6 months

Secondary outcomes

  1. 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.

    Time frame: Up to 6 months

  2. 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.

    Time frame: Up to 6 months

  3. 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.

    Time frame: Up to 6 months

  4. 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.

    Time frame: Up to 6 months

07

Study locations

1 of 1 sites recruiting
  • University of Miami
    Miami, Florida 33136, United States
    • Macarena De La Fuente, MD · Contact · mdelafuente@med.miami.edu · 305-243-4951
    • Macarena De La Fuente, MD · Principal investigator
    Recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.

Of 231 non-industry phase 1 interventional studies under Glioblastoma, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 79. This study's planned 12 months is below that.

Counting every sponsor, half of 303 studies reached it within 46 months; a quarter within 30 and three quarters within 79.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2026
First posted
Oct 20, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Dec 1, 2027
CompletionEst.
Dec 1, 2027
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07884344
Lead sponsor
Macarena De La Fuente, MD
Collaborators
ImmunoMet Therapeutics, Inc.
Responsible party
Macarena De La Fuente, MD (Professor, University of Miami) — Sponsor-investigator
First posted
Oct 20, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Oct 20, 2026

Study contacts

Macarena De La Fuente, MD
Contact
mdelafuente@med.miami.edu
305-243-4951
Macarena De La Fuente, MD
principal investigator · University of Miami

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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