NCT07791264

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

Not Yet Recruiting · Phase 1 · City of Hope Medical Center · registry updated 2026-08-27

Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.

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.

Inclusion

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

Exclusion

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

Open NCT07791264 on ClinicalTrials.gov All conditions