clinical trial · NCT07703436
Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease
Grade 2 IDH1-mutant GliomaGrade 3 IDH1-mutant GliomaGliomaIDH1-mutant GliomaOligodendrogliomaOligodendroglioma IDH-1 Mutant and 1/p19q-codeletedAstrocytoma IDH Mutant Grade 3Astrocytoma IDH Mutant Grade 2Safusidenib
brief summary
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.
started
Mar 1, 2027
primary completion
Sep 1, 2030
completion
Mar 1, 2032
last updated
Jul 14, 2026
official title
A Phase 2, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol