AzTrials
AzTrials

Glioma : Oligodendroglioma or AstrocytomaPhase 2SAFU-G3NCT07832123

Safusidenib for Patients With Newly Diagnosed IDH1-mutant CNS WHO Grade 3 Oligodendroglioma and Astrocytoma - a Single Arm Phase II Study

A Phase 2 study testing Safusidenib in people with Glioma : Oligodendroglioma or Astrocytoma, run by University of Zurich at 1 site in Switzerland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The precise positioning of the emerging group of pharmacological inhibitors of mutant IDH enzymes remains to be refined by further studies and defined in national and international guidelines. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Safusidenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSwitzerland
Study dates
Mar 2027to Sep 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Male or female, age ≥18 years.
  • Newly diagnosed and histologically confirmed IDH1-mutant WHO grade 3 glioma, without or with residual disease: astrocytoma IDH1-mutant, or oligodendroglioma, IDH1-mutant and 1p/19q-codeleted, CNS WHO grade 3. IDH1 mutation can be defined by immunohistochemistry or by sequencing. Any location in the central nervous system is permitted.
  • Karnofsky performance status of 70 or more.
  • Adequate hematologic and organ functions.
  • If taking corticosteroids, patients must be on a stable or decreasing dose for the 14 days prior first dose of study drug.
  • Female patients must be either documented not to be Women of Childbearing Potential (WOCBP) or must have a negative pregnancy test within 14 days of starting treatment. Additionally WOCBP must agree to use, from the screening to at least 90 days following the last administration of safusidenib, highly effective contraception methods. Male subjects able to father children must agree to use two acceptable methods of contraception throughout the study and during at least 90 days following the last administration of safusidenib (e.g., condom with spermicidal gel). Double-barrier contraception is required.
  • Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
  • Written informed consent for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention.

Who cannot join

  • Inability to undergo brain or spine MRI.
  • Intent to be treated with radiotherapy or alkylating agent chemotherapy.
  • Any investigational antitumor therapy other than those under investigation in this study.
  • Any severe concomitant condition including active and uncontrolled infections or other severe concurrent disease, which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol, in the opinion of the investigator.
  • Known hypersensitivity to safusidenib, to any drug with similar chemical structure, or to any other excipient present in the pharmaceutical form of safusidenib.
  • Subjects with a corrected QT interval by Fredericia's formula (QTcF) ≥470 milliseconds (msec) or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome).
Show all 17Show fewer
  • Subjects with history of significant cardiac disease within 12 months prior to first dose of study drug.
  • Subjects with known human immunodeficiency virus (HIV) are ineligible unless the following criteria are met: have been receiving effective antiretroviral therapy for at least 4 weeks; viral load <400 copies/mL, CD4+ T-cell (CD4+) counts ≥350 cells/μL, an absence of opportunistic infections for the last 12 months, and participant agrees to be treated with anti-viral therapy for the duration of the study, if indicated.
  • Subjects with acute or reactivated hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • Subjects with known history and/or serological evidence of chronic HBV infection will be included only if the following criteria are met: hepatitis B- deoxyribonucleic acid (DNA) viral load is below the limit of quantification, liver function tests meet inclusion criteria (AST, ALT, ALP, bilirubin), and participant agrees to be treated with anti-viral therapy for the duration of the study, if indicated.
  • Subjects with known history and/or serological evidence of HCV infection will be included only if the following criteria are met: hepatitis C-ribonucleic acid (RNA) viral load is below the limit of quantification, liver function tests meet inclusion criteria (AST, ALT, ALP, bilirubin), and participant agrees to be treated with anti-viral therapy for the duration of the study, if indicated.
  • Judgment by the investigator that the patient should not participate in the study because the patient is unlikely to comply with study procedures, restrictions and requirements. Only patients capable of judgment can be enrolled.
  • Pregnancy or intention to become pregnant during the course of the study. WOCBP potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test.
  • Women who are breast feeding and who do not agree to discontinue nursing prior to the first study treatment and for the period defined in the protocol.
  • Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.
  • Concurrent malignancies unless the patient has been disease-free without intervention for at least one year.
  • Concurrent use of other anti-cancer treatments or agents other than study medication.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Emilie Le Rhun, MD PhD contact

+41 44 255 55 00

emilie.lerhun@usz.ch

Switzerland1 site

  • University Hospital Zürich

    Zurich, Canton of Zurich

    Emilie Le Rhun, MD PhD, emilie.lerhun@usz.ch

Other trials in Switzerland

About this study

The precise positioning of the emerging group of pharmacological inhibitors of mutant IDH enzymes remains to be refined by further studies and defined in national and international guidelines. The present study shall help to close this important knowledge gap when trying to define the role of mutant IDH inhibitors in the treatment algorithms for patients with IDH-mutant WHO grade 3 gliomas.

Safusidenib is a novel, oral, potent, brain penetrant inhibitor of mutant IDH1. It has shown high blood brain barrier penetration in both pre-clinical and clinical studies and demonstrated anti-tumor activity with complete or partial responses.

We aim at demonstrating the efficacy of safusidenib in patients with newly diagnosed IDH1-mutant CNS WHO grade 3 oligodendroglioma and astrocytoma, measured by progression-free survival at12 months.

Read the detailed description

Patients meeting the eligibility criteria will be asked whether they are willing to participate in the study. After the consent has been signed, patients will be enrolled. They will then start treatment with safusidenib, 250 mg BID until disease progression, unacceptable toxicity, withdrawal of consent or at investigator discretion. A brain MRI will be performed every 2 months during the first 6 months and then every 3 months.

Being tested
Safusidenib
Keywords
glioma, oligodendroglioma, astrocytoma, WHO grade 3, IDH inhibitor, safusidenib
Medical subject headings
Astrocytoma, Glioma, Oligodendroglioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SafusidenibDrug

    All participants will receive safusidenib (250 mg BID) until progression or unacceptable toxicity.

Study groups in NCT07832123
Study groupRoleWhat they receive
Safusidenib armExperimentalAll participants will receive safusidenib (250 mg BID) until progression or unacceptable toxicity.
Receives: Drug: Safusidenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression-free survival at12 months

    progression-free survival at 12 months measured by central review of MRI

    Measured: 12 months

Secondary outcomes (8)

  1. Objective response to treatment in patients with measurable disease

    MRI overall objective response measured centrally per RANO 2.0 criteria

    Measured: 24 months

  2. Progression-free survival at 24 months

    Progression-free survival at 24 months measured centrally per RANO 2.0 criteria

    Measured: 24 months

  3. Median progression-free survival

    Median progression-free survival measured centrally per RANO 2.0 criteria

    Measured: 48 months

  4. Safety

    Safety measured by CTCAE V6.0

    Measured: 48 months

  5. Seizure control

    Seizure control measured by the TRESAT questionnaire

    Measured: 48 months

  6. Quality of life (1)

    measured by the EORTC QLQ C30 questionnaires

    Measured: 48 months

  7. Quality of life (2)

    measured by the EORTC quality of life questionnaire BN20

    Measured: 48 months

  8. Neurological status

    measured by the NANO scorecard

    Measured: 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2026
  2. Study startMar 2027 (estimated)
  3. Primary completionMar 2029 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07832123
Sponsor's protocol ID
UZurich
Acronym
SAFU-G3
Status last verified
Sep 2026
First submitted
15 Sep 2026
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Participant' decisions

Publications

  • Drummond KJ, Spiteri M, Cain SA, Jones J, Shaya S, Topp M, Lu T, Tobler R, Valkovic AL, Moore Z, Fatunla OE, Kriel J, Moffet JJD, McAlpine H, Rosier M, Guan H, Dimou J, Schadewaldt V, Roberts-Thomson S, McArdle D, Lui E, Voelker-Albert M, di Sanzo S, Nijagal B, Narayana VK, Mitchell CB, Vissers JHA, Grimmond S, Rosenthal MA, Palmer LM, Best SA, Freytag S, Whittle JR. Perioperative IDH inhibition in treatment-naive IDH-mutant glioma: a pilot trial. Nat Med. 2025 Oct;31(10):3451-3463. doi: 10.1038/s41591-025-03884-4. Epub 2025 Aug 21.

    PubMed 40841487

  • Arakawa Y, Saito R, Kanemura Y, Mishima K, Koriyama S, Narita Y, Kumabe T, Motomura K, Sugiyama K, Yamasaki F, Mukasa A, Kanamori M, Kuga D, Nagane M, Kakurai Y, Isobe K, Nakamura H. Phase II study of safusidenib erbumine in patients with chemotherapy- and radiotherapy-naive isocitrate dehydrogenase 1-mutated WHO grade 2 gliomas. Neuro Oncol. 2026 Mar 1;28(3):717-727. doi: 10.1093/neuonc/noaf258.

    PubMed 41206766

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Safusidenib in people with Glioma : Oligodendroglioma or Astrocytoma, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emilie Le Rhun, MD PhD (+41 44 255 55 00, emilie.lerhun@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression-free survival at12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07832123, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in