Grade 2 IDH1-mutant GliomaPhase 2NCT07703436
Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease
A Phase 2 study testing Safusidenib in people with Grade 2 IDH1-mutant Glioma and Grade 3 IDH1-mutant Glioma, run by Nuvation Bio Inc. at 12 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grade 2 IDH1-mutant Glioma, Grade 3 IDH1-mutant Glioma, Glioma
- What is being tested?
- Safusidenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 12 sitesUnited States
- Study dates
- Mar 2027to Mar 2032
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 12 recruiting
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02214
Vihang Nakhate, 617-724-8770, vnakhate@mgh.harvard.edu
Vihang Nakhate, MD
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44106
Marci Ciolfi, 216-445-3307, ciolfim@ccf.org
Mina Lobbous, MD
- Not yet recruiting
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Pierre Giglio, 614-293-4448, Pierre.Giglio@osumc.edu
Pierre Giglio, MD
- Not yet recruiting
Indiana University
Indianapolis, Indiana, 46202
NeuroOncology Clinical Trials, 3179634823, neuroct@iu.edu
Kathryn Nevel, MD
- Not yet recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Quan Li, 310-825-1416, quanli@mednet.ucla.edu
Robert Chong, MD
- Not yet recruiting
University of Miami Health
Miami, Florida, 33136
Leonela Wright, 305-243-0864, lxw612@med.miami.edu
Juan Blaquier, MD
- Not yet recruiting
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
Kasie Diorio, 732-235-2465, kassie.diorio@rutgers.edu
Morana Vojnic, MD
- Not yet recruiting
Yale University
New Haven, Connecticut, 06510
Amy Rodrigues, amy.rodrigues@yale.edu
cto-neuro@yale.edu
- Not yet recruiting
LSU LCMC Health Cancer Center
New Orleans, Louisiana, 70112
Yazmin Odia, (646) 634-9655, yodia@lsuhsc.edu
Yazmin Odia, MD
- Recruiting
NYU Langone Health
New York, New York, 10016
Jose McFaline-Figueroa, MD, 212-731-6267, Jose.McFalineFigueroa@nyulangone.org
- Not yet recruiting
Columbia University Medical Center
New York, New York, 10032
Research Nurse Navigator, 212-342-5162, Cancerclinicaltrials@cumc.columbia.edu
Andrew Lassman, MD
- Not yet recruiting
University of California, San Francisco
San Francisco, California, 94143
Neuro Onc New Patient Coordinator, 415-353-2193, neurooncnewpatientcoord@ucsf.edu
John De Groot, MD
About this study
Official 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
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
- Being tested
- Safusidenib
- Medical subject headings
- Glioma, Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafusidenibDrug
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 group | Role | What they receive |
|---|---|---|
| Safusidenib | Experimental | Safusidenib 250 mg BID Receives: Drug: Safusidenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
TGR defined as the percentage change in tumor volume by unit of time, assessed by BICR
Measured: 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
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.
Measured: 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)
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
Measured: 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
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.
Measured: From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months
Time to Response (TTR) per modified RANO 2.0 assessed by BICR and by Investigator
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
Measured: From the date of first dose of study drug to the first documentation of objective response (CR, PR, or MR), approximately 18 months
Overall Survival (OS)
OS, defined as the time from the first dose of study drug to death from any cause.
Measured: From the date of first dose of study drug until the date of death, approximately 18 months
Safety and tolerability
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
Measured: 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
Seizure Activity
Evaluate seizure frequencies and severity including type of seizure, seizure-related AEs, and changes in anti-epileptic medications in participants receiving safusidenib
Measured: From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study startMar 2027 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grade 2 IDH1-mutant GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuvation Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703436
- Sponsor's protocol ID
- NUV-218-G209
- Status last verified
- Oct 2026
- First submitted
- 9 Jul 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No