Clinical Trial

Phase 0 With Expansion Phase Clinical Trial of Quisinostat Plus Radiotherapy in Newly-diagnosed and Recurrent Grade 4 IDH-Wildtype Glioblastomas

Active, Not Recruiting Early Phase 1
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Record status
This record was last updated March 17, 2026 (before its estimated July 15, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is an open-label, multi-center Phase 0/1b study that will enroll up to 18 participants with recurrent WHO grade 4 glioblastoma (rGBM) IDH-wildtype (IDH-WT), Arm A, and 12 participants with presumed newly-diagnosed WHO grade 4 glioblastoma (nGBM) IDH-WT, Arm B. The trial will be composed of a Phase 0 component (subdivided into Arms A and B), and an Expansion Phase 1b. Patients with tumors demonstrating a positive pharmacokinetic (PK) response in the Phase 0 component of the study will graduate to an Expansion Phase that combines therapeutic dosing of quisinostat plus standard-of-care fractionated radiotherapy (RT).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-02-07; most recent amendment 2026-03-16.
Status change: Recruiting → Active, Not Recruiting 2026-03-16
Status change: Not Yet Recruiting → Recruiting 2025-09-22
Trial Details
NCT Number NCT06824662
Lead Sponsor Nader Sanai
Conditions Glioblastoma WHO Grade IV
Enrollment 30 participants
Start Date 2025-09-04
Primary Completion 2026-07-15 (estimated)
Study Completion 2028-01-14 (estimated)
Updated on ClinicalTrials.gov 2026-03-17