Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease
← catalyst calendarNCT07703436 · readout ≤ 1,503 d
Sponsored by Nuvation Bio Inc. (industry) · NUVB — their whole pipeline →.
Phase
Phase 2
Status
Not yet recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
40estimated
Sites
5
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | Mar 2027 | estimated | When the study began enrolling |
| Primary completion | Sep 2030 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2032 | estimated | The whole study's end, after follow-up |
| First posted | 2026-07-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Grade 2 IDH1-mutant Glioma
- Grade 3 IDH1-mutant Glioma
- Glioma
- IDH1-mutant Glioma
- Oligodendroglioma
- Oligodendroglioma IDH-1 Mutant and 1/p19q-codeleted
- Astrocytoma IDH Mutant Grade 3
- Astrocytoma IDH Mutant Grade 2
Intervention
- Drug: Safusidenib
Primary outcome
what the primary-completion date above is the date OFObjective Response Rate (ORR) per modified Response Assessment in Neuro-Oncology (RANO) 2.0 assessed by Blinded Independent Central Review (BICR)
measured From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months
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