Recruiting
Phase 2

VorasiDenib

Sponsor:

Nuvation Bio Inc.

Code:

NCT07703436

Conditions

Grade 2 IDH1-mutant Glioma

Grade 3 IDH1-mutant Glioma

Glioma

IDH1-mutant Glioma

Oligodendroglioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Safusidenib

Study Details

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.

Conditions

Grade 2 IDH1-mutant Glioma

Grade 3 IDH1-mutant Glioma

Glioma

IDH1-mutant Glioma

Oligodendroglioma

Study ID

NCT07703436

Start date

Mar, 2027

Status verified date

Oct, 2026

Completion date

Mar, 2032

Anticipated

Primary completion date

Sep, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Safusidenib

Safusidenib 250 mg BID

Interventions

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.

Primary outcome measure

  • Objective Response Rate (ORR) per modified Response Assessment in Neuro-Oncology (RANO) 2.0 assessed by Blinded Independent Central Review (BICR) [ Time Frame: From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months ]

Central Contacts and Locations

Central contacts

Clinical Trials at Nuvation Bio

332-208-6102ClinicalTrials@nuvationbio.com

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Jose McFaline-Figueroa, MD

212-731-6267Jose.McFalineFigueroa@nyulangone.org

More Information

Sponsor

Nuvation Bio Inc.

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-21. This information was provided to ClinicalTrials.gov by Nuvation Bio Inc. on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.