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

ClinicalTrials.gov ID

NCT07703436

Lead Sponsor

Nuvation Bio Inc.INDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

40Estimated

Last Update Posted

Aug 28, 2026Actual

Start Date

Mar 2027Estimated

Primary Completion Date

Sep 2030Estimated

Completion Date

Mar 2032Estimated

Official Title

A Phase 2, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease

Brief 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.

• 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

• Safusidenib

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Nuvation Bio Inc.INDUSTRY

neurooncnewpatientcoord@ucsf.edu415-353-2193

amy.rodrigues@yale.edu

neuroct@iu.edu3179634823

kassie.diorio@rutgers.edu732-235-2465

Jose.McFalineFigueroa@nyulangone.org212-731-6267

Cancerclinicaltrials@cumc.columbia.edu212-342-5162

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