Safety and Efficacy Study of Safusidenib in Participants With Grade 2 IDH1-Mutant Glioma

NCT07712757 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: NUV-218-G307
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study comparing the efficacy and safety of safusidenib versus placebo in participants with residual or recurrent Grade 2 glioma (oligodendroglioma or astrocytoma) with an IDH1 mutation who have undergone surgery as their only treatment and are not in need of immediate chemotherapy or radiotherapy.

Conditions

Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation; Astrocytoma IDH Mutant Grade 2; Oligodendroglioma; Oligodendroglioma IDH-mutant and 1p/19q-codeleted; IDH-mutant Gliomas

Keywords

safusidenib; IDH1-mutant Glioma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) per modified Response Assessment in Neuro-Oncology (RANO) 2.0

  PFS, defined as time from date of randomization to the date of the first occurrence of radiographic disease progression per modified RANO 2.0 assessed by BICR or death from any cause, whichever occurs earlier

  From the date of randomization until the date of first documented disease progression, approximately 30 months

Secondary Outcomes (15)

• Objective Response Rate (ORR) assessed by BICR per modified RANO 2.0

  From the date of randomization until the date of first documented disease progression, approximately 30 months

• Time to Next Intervention (TTNI)

  From the date of randomization until the date of the start of another anticancer treatment or date of death, approximately 30 months

• PFS assessed by the Investigator per modified RANO 2.0

  From the date of randomization until the date of first documented disease progression, approximately 30 months

• ORR assessed by the Investigator per modified RANO 2.0

  From the date of randomization until the date of the first documented disease progression, approximately 30 months

• Duration of Response (DOR) assessed by BICR and by the Investigator per modified RANO 2.0

  From the date of randomization until the date of first documented disease progression, approximately 30 months

Study Arms (2)

Safusidenib

EXPERIMENTAL

Safusidenib 250 mg BID

Drug: Safusidenib

Placebo

PLACEBO COMPARATOR

Placebo BID

Drug: Placebo

Interventions

Safusidenib DRUG

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

Safusidenib

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Expected survival of ≥12 months.
• At least 1 prior surgery for glioma (biopsy, sub-total resection, or gross total resection), with the most recent surgery having occurred at least 90 days (or at least 28 days if biopsy only and postoperative changes have resolved per BICR) and no longer than 5 years before the date of randomization
• Have not had any other prior anticancer therapy, including chemotherapy and radiotherapy; and are not in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator.
• Histologically confirmed Grade 2, IDH1-mutant oligodendroglioma or astrocytoma according to World Health Organization Central Nervous System 2021 classification criteria per Investigator assessment.
• IDH1 mutation (R132H/C/G/S/L), identified by polymerase chain reaction, next-generation sequencing (NGS), or immunohistochemistry; and confirmed 1p19q codeletion status by fluorescence in situ hybridization, NGS, or array comparative genomic hybridization.
• Residual or recurrent, measurable, non-enhancing disease, as confirmed by BICR per RANO 2.0, assessed at Screening.
• Adequate hematologic and organ functions

You may not qualify if:

• Any prior anticancer therapy other than surgery (biopsy, sub-total, or gross total resection) for treatment of glioma, including chemotherapy, investigational therapies, prior therapies targeting IDH1 or IDH2, anti-angiogenic therapies, tumor-treating fields, or radiotherapy.
• High-risk features as assessed by the Investigator, including brainstem or spinal cord involvement either as primary location or by significant tumor extension, clinically relevant functional or neurocognitive deficits due to the tumor (deficits resulting from surgery are allowed), or uncontrolled seizures (defined as persistent seizures interfering with ability to comply with protocol requirements).
• 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.

Sponsors & Collaborators

• Nuvation Bio Inc.: lead

MeSH Terms

Conditions

Astrocytoma; Oligodendroglioma

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Clinical Trials at Nuvation Bio

CONTACT

332-208-6102; ClinicalTrials@nuvationbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Sponsor and Sponsor representatives (including the CRO) will be blinded to the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled with the possibility for crossover for participants receiving placebo should they meet specific eligibility requirements.

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 17, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): March 1, 2032
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share