Nuvation Bio registers two new trials for IDH1-mutant glioma drug safusidenib
Nuvation Bio posted two new not-yet-recruiting studies testing safusidenib in IDH1-mutant glioma, one Phase 3 and one Phase 2, both listed on ClinicalTrials.gov.
Nuvation Bio filed two new trial registrations this week for safusidenib, an IDH1 inhibitor, in glioma populations.
- A Phase 3 study (NCT07712757, "NUV-218-G307") is not yet recruiting and will compare 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.1 The study plans to enroll 140 participants (estimated)1 and its primary outcome is Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) per modified Response Assessment in Neuro-Oncology (RANO) 2.01.
- A Phase 2 study (NCT07703436, "NUV-218-G209") is also not yet recruiting and covers 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, and are not in need of immediate chemotherapy or radiotherapy.2 Enrollment is planned for 40 participants (estimated)2, with a primary endpoint of Objective Response Rate (ORR) per modified RANO 2.0 assessed by BICR2.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.