Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 MutationPhase 3NCT07712757
Safety and Efficacy Study of Safusidenib in Participants With Grade 2 IDH1-Mutant Glioma
A Phase 3 study testing Safusidenib in people with Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation and Astrocytoma IDH Mutant Grade 2, run by Nuvation Bio Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation, Astrocytoma IDH Mutant Grade 2, Oligodendroglioma
- What is being tested?
- Safusidenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Mar 2027to Mar 2032
- Phase
- Phase 3
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
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Safusidenib in Participants With Grade 2 Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma
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
- Being tested
- Safusidenib, Placebo
- Keywords
- safusidenib, IDH1-mutant Glioma
- Medical subject headings
- Astrocytoma, 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 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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Safusidenib | Experimental | Safusidenib 250 mg BID Receives: Drug: Safusidenib |
| Placebo | Placebo comparator | Placebo BID Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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 randomization until the date of first documented disease progression, approximately 30 months
Time to Next Intervention (TTNI)
TTNI, defined as the time from randomization to the initiation of first subsequent anticancer therapy or death from any cause, whichever occurs earlier.
Measured: 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
PFS, defined as the time from date of randomization to the date of the first occurrence of radiographic disease progression per modified RANO 2.0 assessed by the Investigator or death from any cause, whichever occurs earlier
Measured: 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
ORR, defined as the proportion of participants with the confirmed best overall response of CR, PR, and MR per modified RANO 2.0 as assessed by the investigator.
Measured: 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
DOR, the 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 or death from any cause, whichever occurs earlier, as assessed by BICR and by the Investigator.
Measured: From the date of randomization until the date of first documented disease progression, approximately 30 months
Time to Response (TTR) assessed by BICR and by the Investigator per modified RANO 2.0
TTR, defined as the time from randomization 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 randomization to the first documentation of objective response (CR, PR, or MR), approximately 30 months
Disease Control Rate (DCR) assessed by BICR and by the Investigator per modified RANO 2.0
DCR, defined as the proportion of participants with a best overall response of CR, PR, MR, or stable disease (SD) per modified RANO 2.0, as assessed by BICR and by the Investigator
Measured: From the date of randomization until the date of first documented disease progression, approximately 30 months
Tumor Growth Rate (TGR) by volume assessed 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 30 months
Overall Survival (OS)
OS, defined as the time from randomization to death from any cause
Measured: From the date of randomization until the date of death, approximately 30 months
Safety and tolerability
The safety and tolerability of safusidenib compared with placebo 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 first dose of study drug until 30 days after treatment discontinuation, approximately 30 months
Safusidenib PK Profile
Characterize the safusidenib concentrations
Measured: From the first dose of study drug through approximately 16 weeks
Health-Related Quality of Life
Evaluate health-related quality of life (HRQoL) with safusidenib compared with placebo assessed by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire scores.
Measured: From the first dose of study drug to treatment discontinuation, approximately 30 months
Health-Related Quality of Life
Evaluate health-related quality of life (HRQoL) with safusidenib compared with placebo assessed by the Quality of Life in Epilepsy (QOLIE-10-P) scores.
Measured: From the first dose of study drug to treatment discontinuation, approximately 30 months
Health-Related Quality of Life
Evaluate health-related quality of life (HRQoL) with safusidenib compared with placebo assessed by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire scores.
Measured: From the first dose of study drug to treatment discontinuation, approximately 30 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 compared with placebo
Measured: From the date of randomization until the date of first documented disease progression, approximately 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study startMar 2027 (estimated)
- Primary completionMay 2029 (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 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 MutationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled with the possibility for crossover for participants receiving placebo should they meet specific eligibility requirements.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 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
- NCT07712757
- Sponsor's protocol ID
- NUV-218-G307
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No