Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease

This study will include up to 40 participants with Grade 2 or Grade 3 IDH1-mutant glioma who have undergone surgery and received vorasidenib as their only treatment, experienced radiographic disease progression on vorasidenib (confirmed by Blinded Independent Central Review \[BICR\] per modified Response Assessment in Neuro-Oncology \[RANO\] 2.0), and are not in need of immediate chemotherapy or radiotherapy.

NCT Number	NCT07703436
Lead Sponsor	Nuvation Bio Inc.
Conditions	Grade 2 IDH1-mutant Glioma, Grade 3 IDH1-mutant Glioma, Glioma, IDH1-mutant Glioma, Oligodendroglioma, Oligodendroglioma IDH-1 Mutant and 1/p19q-codeleted, Astrocytoma IDH Mutant Grade 3, Astrocytoma IDH Mutant Grade 2
Enrollment	40 participants
Start Date	2027-03
Primary Completion	2030-09 (estimated)
Study Completion	2032-03 (estimated)
Updated on ClinicalTrials.gov	2026-08-11