Trial Profile

A Phase 2, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Patients With Isocitrate Dehydrogenase 1 (IDH1) Mutant Glioma

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 18 Feb 2026

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At a glance

09 Feb 2026 According to Nuvation Bio media release, company expects initial data for the separate oligodendroglioma cohort in 2027.
09 Feb 2026 According to Nuvation Bio media release, SIGMA trial is enrolling and now includes grade 2 astrocytoma with high-risk features in the maintenance setting plus a non-pivotal single-arm cohort for chemotherapy and radiotherapy-naive grade 3 IDH1-mutant oligodendroglioma patients.
09 Feb 2026 According to Nuvation Bio media release, company has announced that it has finalized a protocol amendment for its ongoing global SIGMA study of safusidenib, expanding the trial to phase 3.

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