Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07703436

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Grade 2 IDH1-mutant Glioma Astrocytoma IDH Mutant Grade 2 Astrocytoma IDH Mutant Grade 3 Glioma Grade 3 IDH1-mutant Glioma IDH1-mutant Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Oligodendroglioma Oligodendroglioma IDH-1 Mutant and 1/p19q-codeleted

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

    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

Secondary outcomes

  1. ORR per modified RANO 2.0 assessed by Investigator

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

    ORR defined as the proportion of participants with the confirmed best overall response of CR, PR or MR per modified RANO 2.0, assessed by the Investigator

  2. Volumetric Tumor Growth Rate (TGR) by BICR

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

    TGR defined as the percentage change in tumor volume by unit of time, assessed by BICR

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

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

    DOR, time from the first documentation of objective response (CR, PR, or MR) to the date of the first occurrence of radiographic disease progression per modified RANO 2.0 assessed by BICR and by the Investigator or death from any cause, whichever occurs earlier.

  4. Time to Next Intervention (TTNI)

    Time frame: 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

    TTNI, defined as the time from the first dose of study drug to the initiation of first subsequent anticancer therapy or death from any cause, whichever occurs earlier

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

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

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

  6. Time to Response (TTR) per modified RANO 2.0 assessed by BICR and by Investigator

    Time frame: From the date of first dose of study drug to the first documentation of objective response (CR, PR, or MR), approximately 18 months

    TTR, defined as the time from the first dose of study drug to the first documentation of objective response (CR, PR, or MR) per modified RANO 2.0, assessed by BICR and by the Investigator

  7. Overall Survival (OS)

    Time frame: From the date of first dose of study drug until the date of death, approximately 18 months

    OS, defined as the time from the first dose of study drug to death from any cause.

  8. Safety and tolerability

    Time frame: From the date of first dose of study drug until 30 days after the date of the last dose of study drug, approximately 18 months

    The safety and tolerability of safusidenib evaluated based on AEs graded by NCI-CTCAE version 5.0, laboratory abnormalities as graded by NCI-CTCAE version 5.0, vital signs, physical examinations, and ECGs

  9. Seizure Activity

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

    Evaluate seizure frequencies and severity including type of seizure, seizure-related AEs, and changes in anti-epileptic medications in participants receiving safusidenib

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials at Nuvation Bio

CONTACT

[email protected]

332-208-6102

Sponsors and collaborators

Lead sponsor

Nuvation Bio Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2027
Primary completion
2030
Study completion
2032
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.