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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Nuvation Bio Inc. • ClinicalTrials.gov ID: NCT07703436

Registry updated: 2026-10-20
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Description

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.

Interventions

  • Safusidenib (Drug)
    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.

Eligibility criteria

Key Inclusion Criteria: * 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. * Previously treated with vorasidenib and experienced radiographic disease progression during treatment and are not in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator. Disease progression must be confirmed by BICR using modified RANO 2.0. * Adequate hematologic and organ function * Expected survival of ≥12 months Key Exclusion Criteria: * 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. * Significant functional or neurocognitive deficits, including uncontrolled seizures * Evidence of leptomeningeal disease. * Use of therapeutic doses of steroids for signs/symptoms of glioma. Participants taking physiologic doses (defined as equivalent of \<1.5 mg of dexamethasone equivalent) for medical conditions not related to glioma will be permitted.

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

Locations

  • University of California, Los Angeles — Los Angeles, California, United States
  • University of California, San Francisco — San Francisco, California, United States
  • Yale University — New Haven, Connecticut, United States
  • University of Miami Health — Miami, Florida, United States
  • Indiana University — Indianapolis, Indiana, United States
  • LSU LCMC Health Cancer Center — New Orleans, Louisiana, United States
  • Massachusetts General Hospital — Boston, Massachusetts, United States
  • Rutgers Cancer Institute — New Brunswick, New Jersey, United States
  • NYU Langone Health — New York, New York, United States
  • Columbia University Medical Center — New York, New York, United States
  • Cleveland Clinic — Cleveland, Ohio, United States
  • The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record