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

NCT07703436 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-11

No results posted yet for this study

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.

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

Interventions

DRUG

Safusidenib

Safusidenib administered twice daily as a single agent orally on Days 1 to 28 of a 28-day cycle. Participants may continue treatment until disease progression or another reason for discontinuation occurs.

Sponsors & Collaborators

  • Nuvation Bio Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-03-31
Primary Completion
2030-09-30
Completion
2032-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07703436 on ClinicalTrials.gov