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

NCT07703436 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: NUV-218-G209
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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; Oligodendroglioma IDH-1 Mutant and 1/p19q-codeleted; Astrocytoma IDH Mutant Grade 3; Astrocytoma IDH Mutant Grade 2

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) per modified Response Assessment in Neuro-Oncology (RANO) 2.0 assessed by Blinded Independent Central Review (BICR)

  ORR defined as the proportion of participants with the confirmed best overall response of Complete Response (CR), Partial Response (PR) or Minor Response (MR) per modified RANO 2.0, assessed by BICR

  From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months

Secondary Outcomes (9)

• ORR per modified RANO 2.0 assessed by Investigator

  From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months

• Volumetric Tumor Growth Rate (TGR) by BICR

  From historical scans through the final scan in the study, approximately 18 months

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

  From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months

• Time to Next Intervention (TTNI)

  From the date of first dose of study drug until the date of the start of another anticancer treatment or date of death, approximately 18 months

• Progression Free Survival (PFS) per modified RANO 2.0 assessed by BICR and by Investigator

  From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months

Study Arms (1)

Safusidenib

EXPERIMENTAL

Safusidenib 250 mg BID

Drug: Safusidenib

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.

Safusidenib

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nuvation Bio Inc.: lead

MeSH Terms

Conditions

Glioma; Oligodendroglioma

Condition Hierarchy (Ancestors)

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 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): March 1, 2032
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share