Can a RAGE inhibitor tame brain swelling after tumor surgery?

NCT ID NCT07791264

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This phase 1 trial tests whether FPS-ZM1, a drug that blocks an inflammation pathway, can safely control brain swelling that often occurs after surgery for glioblastoma, a type of brain cancer. Researchers will give FPS-ZM1 with or without the steroid dexamethasone to about 24 adults who are scheduled for tumor removal. The study aims to find the best dose and check for side effects, while also measuring how much of the drug reaches the brain and tumor tissue.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FPS-ZM1, a RAGE inhibitor that blocks an inflammation pathway, given with or without dexamethasone
What this could lead to
If it works, this could offer a new way to control brain swelling after glioblastoma surgery, potentially reducing the need for steroids and improving recovery.
What could go wrong
This is an early phase 1 trial with only 24 participants, so the drug may not prove safe or effective. Side effects and dosing issues are still being explored.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2027

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * 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) Exclusion Criteria: * 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 * 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)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • City of Hope Medical Center

    Duarte, California, 91010, United States

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