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

Sponsor
Nuvation Bio Inc.
Study ID
NCT07703436
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Astrocytoma IDH Mutant Grade 2
  • Astrocytoma IDH Mutant Grade 3
  • Glioma
  • Grade 2 IDH1-mutant Glioma
  • Grade 3 IDH1-mutant Glioma
  • IDH1-mutant Glioma
  • Oligodendroglioma
  • Oligodendroglioma IDH-1 Mutant and 1/p19q-codeleted

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jul 14, 2026
Start date
Mar 31, 2027
Status verified
Jul 2026
Primary completion
Sep 30, 2030
Completion
Mar 31, 2032

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Safusidenib
    Safusidenib 250 mg BID

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

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