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NOT YET RECRUITING
NCT07791264
PHASE1

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

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2027-02-17

Completion Date

2028-08-28

Last Updated

2026-08-27

Healthy Volunteers

No

Interventions

PROCEDURE

Biospecimen Collection

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

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Dexamethasone

Given IV or PO

PROCEDURE

Invasive Procedure

Undergo placement of a temporary peritumoral microdialysis catheter

PROCEDURE

Invasive Procedure

Undergo intracavity drain placement

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

RAGE Antagonist FPS-ZM1

Given PO

PROCEDURE

Resection

Undergo resection surgery

Locations (1)

City of Hope Medical Center

Duarte, California, United States