Safety and Efficacy Study of Safusidenib in Participants With Grade 2 IDH1-Mutant Glioma

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study comparing the efficacy and safety of safusidenib versus placebo in participants with residual or recurrent Grade 2 glioma (oligodendroglioma or astrocytoma) with an IDH1 mutation who have undergone surgery as their only treatment and are not in need of immediate chemotherapy or radiotherapy.

NCT Number	NCT07712757
Lead Sponsor	Nuvation Bio Inc.
Conditions	Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation, Astrocytoma IDH Mutant Grade 2, Oligodendroglioma, Oligodendroglioma IDH-mutant and 1p/19q-codeleted, IDH-mutant Gliomas
Enrollment	140 participants
Start Date	2027-03
Primary Completion	2029-05 (estimated)
Study Completion	2032-03 (estimated)
Updated on ClinicalTrials.gov	2026-07-17