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GlioblastomaPhase 1NCT07791264

FPS-ZM1 With or Without Dexamethasone for Controlling Post Operative Cerebral Edema in Patients With Glioblastoma

A Phase 1 study testing Biospecimen Collection, Computed Tomography and Dexamethasone in people with Glioblastoma and Malignant Glioma, run by City of Hope Medical Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This phase I trial tests the safety, side effects, best dose and how well FPS-ZM1 works for controlling post operative cerebral edema in patients with glioblastoma. FPS-ZM1 works by blocking the pathway that controls inflammation. Dexamethasone is in a class of medications called corticosteroids. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Computed Tomography and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
17 Feb 2027to 28 Aug 2028
Phase
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

  • Documented informed consent given by the participant. Non-English speaking adults are eligible for participation if they have the capacity to understand and consent to the study procedures
  • Age: ≥ 18 years
  • Karnofsky Performance Status (KPS) ≥ 70%
  • Histologically confirmed glioblastoma or radiographic findings consistent with a high grade glioma
  • Newly diagnosed or recurrent tumor
  • The patient is planning to undergo a standard-of-care craniotomy for gross total resection of enhancing tumor
Show all 33Show fewer
  • The patient's pre-operative brain MRI shows the presence of mild to moderate cerebral edema, defined as a midline shift of less than 10 mm
  • Dose Levels 1-3 participants: If taking more than a total of 6 mg a day of dexamethasone at the time of signing the consent form, it is anticipated by the neurosurgeon that the participant will be able to decrease their dose of dexamethasone to 6 mg daily by 4 days before the surgery (pre-operative Day -4)
  • Dose Level 4 participants: If taking more than 1 mg a day of dexamethasone at the time of signing the consent form, it is anticipated by the neurosurgeon that the participant will be able to taper their dose of dexamethasone to 1 mg daily or less by pre-operative Day -4
  • The patient is not planning to be in another clinical trial during the study period
  • The patient has recovered from any acute toxic effects (except alopecia) to ≤ grade 1 of prior anti-cancer therapy
  • No limit to prior number of therapies. The following time periods must have elapsed prior to the start of study treatment: 6 weeks from nitrosourea-containing chemotherapy, 4 weeks from non-nitrosourea-containing cytotoxic chemotherapy (except 23 days from last daily dose of temozolomide taken in a 5 of 28 day regimen, 5 half-lives from last dose of a targeted agent, and 4 weeks from the last dose of bevacizumab). There is no time period requirement for prior radiation therapy
  • Absolute neutrophil count (ANC) ≥ 1,000/mm^3
  • Platelets ≥ 100,000/mm^3
  • Hemoglobin ≥ 9g/dL
  • Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease)
  • Aspartate aminotransferase (AST) ≤ 1.5 x ULN
  • Alanine aminotransferase (ALT) ≤ 1.5 x ULN
  • Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min
  • International Normalized Ratio (INR) OR Prothrombin (PT) ≤ 1.5 x ULN
  • Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 x ULN
  • Corrected QT interval (QTc) ≤ 450 ms
  • Must have a Fridericia's corrected QT interval (QTcF) ≤ 450 msec calculated with Fridericia formula
  • Left ventricular ejection fraction (LVEF) ≥ 50%
  • People of childbearing potential who have uteri: negative urine or serum pregnancy test
  • Contraception:
  • Agreement by participants of childbearing potential or participants who are partners of people with childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy.
  • Contraception guidance (as per the information included in the informed consent document):
  • Acceptable medically effective forms of birth control are:
  • Surgical sterilization (tubal ligation or hysterectomy, or vasectomy, as applicable),
  • Double-barrier methods (i.e. condoms, diaphragm, cervical cap, or sponge used with spermicidal gel or foam),
  • Intrauterine device (IUD) (i.e. Progestin, Copper),
  • Hormonal Contraceptives (Birth control patches, implants, pills, rings, or injections)

Who cannot join

  • The patient is taking a medication that is a strong or moderate inducer or inhibitor of major CYP450 isoenzymes and drug transporters, and the patient is not able to stop that medication at least 14 days prior to start of study treatment
  • The patient has a risk factor for torsades de pointes, such as structural heart disease (history of myocardial infarction, congestive heart failure, left ventricular hypertrophy), electrolyte abnormalities (hypokalemia, hypomagnesemia), bradycardia or heart blocks, or a family history of Long QT syndrome
  • The patient is taking a medication that prolongs the QT/QTc interval and is not able to stop that medication at least 14 days prior to start of study treatment
  • The patient is unwilling to stop taking herbal medications prior to the start of study treatment
  • The patient is taking a hepatic enzyme-inducing anti-seizure medication within 14 days prior to start of study treatment
  • Patient is planning to participate in clinical trial or start a new therapy for their brain tumor during the study period: Day -2 to Day 14
Show all 20Show fewer
  • Patient has not recovered from toxicities of prior therapy (must be grade 1 or less) except alopecia
  • Adults who lack the capacity to provide informed consent, including individuals who would require consent from a Legally Authorized Representative (LAR)
  • Clinically significant uncontrolled illness
  • Active infection requiring antibiotics
  • Participants with human immunodeficiency virus (HIV) are excluded due to concerns about inadvertent augmentation of infectious and/or inflammatory activity
  • Undergoing treatment for another cancer
  • Issues with tolerating oral medication (e.g. inability to swallow, malabsorption issues, ongoing nausea or vomiting)
  • Chronic or active viral infection of the CNS
  • Participant is pregnant or breastfeeding
  • Coagulopathy or bleeding disorder
  • Inability to undergo a brain MRI
  • Inability to tolerate dexamethasone
  • Any other condition that would, in the investigator's judgment, contraindicate participation in the clinical study due to safety concerns with clinical study procedures
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

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

  • City of Hope Medical Center

    Duarte, California, 91010

    Jana L. Portnow, 626-546-8293, jportnow@coh.org

    Jana L. Portnow

Other trials in United States

About this study

Official title: A Phase 1 Study of the RAGE Inhibitor FPS-ZM1 for Controlling Post-Operative Cerebral Edema in Glioblastoma Patients

This phase I trial tests the safety, side effects, best dose and how well FPS-ZM1 works for controlling post operative cerebral edema in patients with glioblastoma. FPS-ZM1 works by blocking the pathway that controls inflammation. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving FPS-ZM1 with or without dexamethasone may be safe and/or effective in controlling post operative cerebral edema in patients with glioblastoma.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Determine the maximum feasible dose (MFD) of RAGE antagonist FPS-ZM1 (FPS-ZM1) administered peri-operatively to participants with newly diagnosed or recurrent glioblastoma.

SECONDARY OBJECTIVES:

  1. Assess the ability of FPS-ZM1 to control participants' symptoms of post-operative cerebral edema when administered as monotherapy.

II. Describe the systemic pharmacokinetics and central nervous system (CNS) penetration of FPS-ZM1 based on concentrations of FPS-ZM1 in peripheral blood, cerebrospinal fluid (CSF), brain tumor tissue and resection cavity fluid (when obtainable).

III. Characterize cytokine concentrations over time in brain interstitial fluid, peripheral blood and resection cavity fluid (when obtainable) by dose level.

IV. Assess for evidence of RAGE inhibition in tumor tissue, CSF, brain interstitial fluid, resection cavity fluid (when obtainable) and peripheral blood by dose level.

  1. Qualitatively and quantitatively assess changes in volume of cerebral edema on pre-operative brain magnetic resonance imaging (MRIs) and brain MRIs performed on post-operative Days 2 and 14 across dose levels.

OUTLINE: This is a dose-escalation study of FPS-ZM1 in combination with fixed-dose dexamethasone. Patients are assigned to 1 of 2 arms.

ARM I (DOSE LEVELS 1-3): Starting 2 days prior to surgery, patients receive FPS-ZM1 orally (PO) daily (QD) until post operative day 11, and dexamethasone intravenously (IV) or PO QD taper until post operative day 14, in the absence of disease progression or unacceptable toxicity. On day of surgery patients undergo standard of care resection and, if possible, undergo placement of a temporary peritumoral microdialysis catheter and intracavity drain for collection of dialysate and intracavity fluid. Patients undergo urine sample collection during screening, lumbar puncture with CSF collection and computed tomography (CT) scan on study and brain MRI, and blood sample collection throughout the study.

ARM II (DOSE LEVEL 4): Starting 2 days prior to surgery, patients receive FPS-ZM1 PO QD and, if needed for physiologic replacement, a smaller dose of dexamethasone IV or PO QD until post operative day 11, in the absence of disease progression or unacceptable toxicity. On day of surgery patients undergo standard of care resection and, if possible, undergo placement of a temporary peritumoral microdialysis catheter and intracavity drain for collection of dialysate and intracavity fluid. Patients undergo urine sample collection during screening, lumbar puncture with CSF collection and CT scan on study and brain MRI, and blood sample collection throughout the study.

After completion of study treatment, patients are followed up at day 30.

Being tested
Biospecimen Collection, Computed Tomography, Dexamethasone, Invasive Procedure, Magnetic Resonance Imaging
Medical subject headings
Glioblastoma, Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood, dialysate, intracavity fluid, and urine sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • DexamethasoneDrug

    Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex

    Given IV or PO

  • Invasive ProcedureProcedure or surgery

    Also called Invasive

    Undergo placement of a temporary peritumoral microdialysis catheter

  • Invasive ProcedureProcedure or surgery

    Also called Invasive

    Undergo intracavity drain placement

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • RAGE Antagonist FPS-ZM1Drug

    Also called FPS ZM1, FPS-ZM1, FPSZM1, RAGE Inhibitor FPS-ZM1

    Given PO

  • ResectionProcedure or surgery

    Also called Surgical Resection

    Undergo resection surgery

Study groups in NCT07791264
Study groupRoleWhat they receive
Arm I (FPS-ZM1 and dexamethasone)ExperimentalStarting 2 days prior to surgery, patients receive FPS-ZM1 PO QD until post operative day 11, and dexamethasone IV or PO QD taper until post operative day 14, in the absence of disease progression or unacceptable toxicity. On day of surgery patients undergo standard of care resection and, if possible, undergo placement of a temporary peritumoral microdialysis catheter and intracavity drain for collection of dialysate and intracavity fluid. Patients undergo urine sample collection during screening, lumbar puncture with cerebrospinal fluid collection and CT scan on study and brain MRI, and blood sample collection throughout the study.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Dexamethasone; Procedure: Invasive Procedure; Procedure: Magnetic Resonance Imaging; Drug: RAGE Antagonist FPS-ZM1; Procedure: Resection
Arm II (FPS-ZM1)ExperimentalStarting 2 days prior to surgery, patients receive FPS-ZM1 PO QD and, if needed for physiologic replacement, a smaller dose of dexamethasone IV or PO QD until post operative day 11, in the absence of disease progression or unacceptable toxicity. On day of surgery patients undergo standard of care resection and, if possible, undergo placement of a temporary peritumoral microdialysis catheter and intracavity drain for collection of dialysate and intracavity fluid. Patients undergo urine sample collection during screening, lumbar puncture with cerebrospinal fluid collection and CT scan on study and brain MRI, and blood sample collection throughout the study.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Dexamethasone; Procedure: Invasive Procedure; Procedure: Magnetic Resonance Imaging; Drug: RAGE Antagonist FPS-ZM1; Procedure: Resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RAGE Antagonist FPS-ZM1 (FPS-ZM1) related adverse events

    Assessed per Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.

    Measured: Up to 30 days post surgery

  2. Dose limiting toxicity rate

    Assessed per CTCAE version 6.0.

    Measured: Up to 30 days post surgery

Secondary outcomes (29)

  1. Doses of dexamethasone taken post-operatively by study participants on dose Level 4

    Measured: Up to 30 days post surgery

  2. FPS-ZM1 concentrations in enhancing tumor tissue

    Measured: Up to 30 days post surgery

  3. FPS-ZM1 concentrations in non-enhancing tumor tissue

    Measured: Up to 30 days post surgery

  4. FPS-ZM1 concentrations in cerebrospinal fluid (CSF)

    Measured: Up to 30 days post surgery

  5. FPS-ZM1 concentrations in resection cavity fluid

    Measured: Up to 30 days post surgery

  6. Cytokine concentrations in brain interstitium

    Measured: Up to 30 days post surgery

  7. Cytokine concentrations in peripheral blood

    Measured: Up to 30 days post surgery

  8. Cytokine concentrations in resection cavity fluid

    Measured: Up to 30 days post surgery

  9. Concentrations of RAGE ligands in brain extracellular fluid

    Measured: Up to 30 days post surgery

  10. Concentrations of RAGE ligands in CSF

    Measured: Up to 30 days post surgery

  11. Concentrations of RAGE ligands in resection cavity fluid

    Measured: Up to 30 days post surgery

  12. Concentrations of RAGE ligands in peripheral blood

    Measured: Up to 30 days post surgery

  13. Expression of activating markers on tumor infiltrating lymphocytes

    Measured: Up to 30 days post surgery

  14. Expression of activating markers on myeloid cells

    Measured: Up to 30 days post surgery

  15. Expression of activating markers on lymphocytes in resection cavity fluid

    Measured: Up to 30 days post surgery

  16. Expression of activating markers on myeloid cells in resection cavity fluid

    Measured: Up to 30 days post surgery

  17. Expression of activating markers on lymphocytes in peripheral blood

    Measured: Up to 30 days

  18. Expression of activating markers on myeloid cells in peripheral blood

    Measured: Up to 30 days post surgery

  19. T1 enhancing tumor volume from segmented T1-weighted magnetic resonance imaging (MRI)

    Measured: Up to 30 days post surgery

  20. Mean intratumoral perfusion from dynamic contrast enhanced (DCE)-MRI

    Measured: Up to 30 days post surgery

  21. Interstitial fluid flow from DCE-MRI

    Measured: Up to 30 days post surgery

  22. T2-FLAIR enhancing edema from segmented T2-FLAIR MRI

    Measured: Up to 30 days post surgery

  23. Mean intratumoral blood volume from relative cerebral blood volume as calculated from DSC-MRI

    Measured: Up to 30 days post surgery

  24. Mean intratumoral tissue density as measured by the apparent diffusion coefficient derived from diffusion-weighted MRI

    Measured: Up to 30 days post surgery

  25. Mean intratumoral lactate and glutatione concentration as measured by multiplexed MR spectroscopy

    Measured: Up to 30 days post surgery

  26. FPS-ZM1 plasma pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)

    Measured: Up to 30 days post surgery

  27. FPS-ZM1 plasma pharmacokinetics: Area Under the Plasma Concentration-Time Curve (AUC)

    Measured: Up to 30 days post surgery

  28. FPS-ZM1 plasma pharmacokinetics: Terminal Elimination Half-Life (t½)

    Measured: Up to 30 days post surgery

  29. FPS-ZM1 plasma pharmacokinetics: Clearance (CL)

    Measured: Up to 30 days post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2026
  2. Study start17 Feb 2027 (estimated)
  3. Primary completion28 Aug 2028 (estimated)
  4. Study completion28 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Patients assigned to dose levels 1-3 are assigned to arm I, patients assigned to dose level 4 are assigned to arm II.
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07791264
Sponsor's protocol ID
25116
Other IDs
NCI-2026-05499, 25116, P30CA033572, U19CA264512
Status last verified
Aug 2026
First submitted
6 Aug 2026
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Biospecimen Collection, Computed Tomography and Dexamethasone in people with Glioblastoma and Malignant Glioma, run by City of Hope Medical Center 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 33 inclusion and 20 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: opening soon, as of the sponsor's last update on 27 Aug 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RAGE Antagonist FPS-ZM1 (FPS-ZM1) related adverse events (time frame: Up to 30 days post surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07791264.

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 27 Aug 2026.

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Clinical Trial NCT07791264 | AzTrials