drugset / Trial / NCT07703436

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

NCT07703436 ↗

Phase 2 Not yet recruiting 40 enrolled Nuvation Bio Inc.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2027-03
Primary completion
2030-09
Completion
2032-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Safusidenib Small molecule 250 mg Oral