Sponsor study identifier
Secondary identifiers
REGISTRY · CTRP (Clinical Trial Reporting Program)
OTHER · City of Hope Medical Center
NIH
NIH
interventional
24
1 country
1
Study Start
February 17, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
August 28, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 28, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 28, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 6, 2026
Actual (reported)August 27, 2026
Actual (reported)February 17, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 28, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 28, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
RAGE Antagonist FPS-ZM1 (FPS-ZM1) related adverse events
Assessed per Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Up to 30 days post surgery
Dose limiting toxicity rate
Assessed per CTCAE version 6.0.
Up to 30 days post surgery
Doses of dexamethasone taken post-operatively by study participants on dose Level 4
Up to 30 days post surgery
FPS-ZM1 concentrations in enhancing tumor tissue
Up to 30 days post surgery
FPS-ZM1 concentrations in non-enhancing tumor tissue
Up to 30 days post surgery
FPS-ZM1 concentrations in cerebrospinal fluid (CSF)
Up to 30 days post surgery
FPS-ZM1 concentrations in resection cavity fluid
Up to 30 days post surgery
Starting 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.
Undergo blood, dialysate, intracavity fluid, and urine sample collection
City of Hope Medical Center
Duarte, California, 91010, United States
Jana L Portnow
City of Hope Medical Center
First Submitted
August 6, 2026
First Posted
August 27, 2026
Study Start
February 17, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults
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 cerebrospinal fluid collection and CT scan on study and brain MRI, and blood sample collection throughout the study.
Undergo CT scan
Given IV or PO
Undergo placement of a temporary peritumoral microdialysis catheter
Undergo intracavity drain placement
Undergo MRI
Given PO
Undergo resection surgery
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
August 28, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 28, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 27, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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