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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNuvation Bio Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Histologically confirmed Grade 2 or 3 IDH-mutant astrocytoma or IDH-mutant and 1p19q co-deleted oligodendroglioma, according to WHO CNS 2021 criteria

IDH1 mutation (e.g., R132H/C/G/S/L) based on immunohistochemistry (IHC) (R132H only), PCR, or next generation sequencing (NGS).

Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, or gross total resection).

Measurable disease per modified RANO 2.0 confirmed by BICR during Screening.

Disqualifiers

Any prior anticancer therapy other than surgery (biopsy, sub-total, or gross total resection) and vorasidenib for treatment of glioma.

Discontinued vorasidenib for toxicity or any reason other than radiographic disease progression

Prior treatment with anti-angiogenic agents such as Avastin (bevacizumab) or investigational agents for glioma.

Brainstem or spinal cord involvement either as primary location, site of multifocal involvement, or by significant tumor extension.

Trial design

Treatments tested in this trial

  • Safusidenib

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators