AzTrials
AzTrials

GliomaEarly Phase 1AB-218-IIT-201NCT05577416

A Study of AB-218 in Patients With IDH1 Mutated Low Grade Glioma

A Early Phase 1 study testing Biopsy, Part A: Safusidenib Erbumine and Surgery (maximal resection) in people with Glioma, run by Melbourne Health at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of this clinical trial is to evaluate the feasibility of undertaking a Phase 0 surgical study in patients with diagnosis of a IDH1 mutated Low Grade Glioma (LGG) who have not received prior radiation or chemotherapy and are planned to undergo surgical resection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioma
What is being tested?
Biopsy, Part A: Safusidenib Erbumine and Surgery (maximal resection)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteAustralia
Study dates
11 Oct 2022to 26 Mar 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

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 LGG or new diagnosis of LGG based on MRI
  • Tumours suitable for biopsy and safe for maximal resection in the opinion of the treating neurosurgeon
  • Patients who in the consensus of the treating neurosurgeon require resection of the brain tumour.
  • Patients who do not require immediate definitive resection of the brain tumour in the opinion of the treating neurosurgeon
  • Measurable and/or evaluable disease as per LGG-RANO criteria
  • Age ≥ 18 years of age.
Show all 10Show fewer
  • ECOG performance score 0-1
  • Life expectancy of at least 24 months, in the opinion of the investigator
  • Adequate haematological, renal and hepatic function
  • Reproductive and contraception criteria as prescribed

Who cannot join

  • Patients who meet any of the following criteria will be excluded from participation in the study:
  • Patients who require immediate definitive resection due to degree of mass effect or symptoms
  • Multicentric / multifocal tumour
  • Tumour involves cerebellum or brainstem
  • Patients who have undergone surgery for glioma within 24 months of study enrolment
  • Patients who have received prior chemotherapy and / or radiation for a diagnosis of glioma
Show all 12Show fewer
  • Patients with contraindications to MRI or unwilling to undergo MRI
  • History of central nervous system bleeding as defined by stroke within 6 months before enrolment
  • Evidence of acute intracranial / intra-tumoural haemorrhage, except for participants with stable grade 1 haemorrhage
  • Other general criteria including:
  • ECG abnormalities ii) significant comorbidity or infection iii) Prior malignancy iv) Recent surgery v) Known allergy or sensitivity to any of the excipients in the investigational product vi) no contraindicated concomitant medications
  • History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator would pose a risk to participant safety or interfere with the study evaluation, procedures or completion

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Royal Melbourne Hospital

    Melbourne, Victoria

Other trials in Australia

About this study

Official title: A Phase 0/2 Study of AB-218 in Patients With IDH1 Mutated Low Grade Glioma

The aim of this clinical trial is to evaluate the feasibility of undertaking a Phase 0 surgical study in patients with diagnosis of a IDH1 mutated Low Grade Glioma (LGG) who have not received prior radiation or chemotherapy and are planned to undergo surgical resection.

Read the detailed description

This is a single arm, open label Phase 0 trial to assess the feasibility, pharmacokinetics and pharmacodynamics of treatment with AB-218 following biopsy and prior to resection in patients with IDH1 mutated glioma.

Participants will receive treatment in 2 parts:

Part A: Biopsy followed by 1 cycle (28 days) of Safusidenib Erbumine (formerly AB-218), an orally available, small molecular inhibitor of mutated IDH1, then safe maximal resection of the tumour.

Part B: Following recovery from surgery, patients will receive at least 12 cycles of Safusidenib, subject to ongoing documented evidence of clinical benefit, until disease progression or unacceptable toxicity.

It is expected that 15 patients will take part in this study.

It is anticipated this research study will enable investigators to objectively measure the biological activity of Safusidenib in patients with IDH1 mutated LGG.

Anti-tumour activity will be assessed by RANO response criteria.

The investigators have previous experience in pre-treating patients with GBM prior to surgery with systemic therapies and collecting tumour, peri-tumour and normal brain tissues for PK, PD and biomarker evaluation

Conditions
Glioma
Being tested
Biopsy, Part A: Safusidenib Erbumine, Surgery (maximal resection), Part B: Safusidenib Erbumine
Keywords
IDH1, Diffuse Astrocytoma, oligodendroglioma, phase 0, perioperative
Medical subject headings
Glioma, Astrocytoma, Oligodendroglioma

What participants receive

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

  • BiopsyProcedure or surgery

    Patients will undergo stereotactic biopsy by craniotomy or burr hole.

  • Part A: Safusidenib ErbumineDrug

    Part A: Safusidenib Erbumine orally 250 mg BID for 28 days.

  • Surgery (maximal resection)Procedure or surgery

    Surgery: Maximal safe resection, within 24 hours of last dose of Safusidenib Erbumine.

  • Part B: Safusidenib ErbumineDrug

    Part B: Safusidenib Erbumine orally 250 mg BID for 28 days for a minimum of 12, 28-day cycles subject to ongoing documented evidence of clinical benefit, until disease progression or unacceptable toxicity.

Study groups in NCT05577416
Study groupRoleWhat they receive
Safusidenib Erbumine (AB-218)ExperimentalPart A: Peri-operative treatment (Phase 0); Part B: Post operative adjuvant therapy (phase 2)
Receives: Procedure: Biopsy; Drug: Part A: Safusidenib Erbumine; Procedure: Surgery (maximal resection); Drug: Part B: Safusidenib Erbumine

What is being measured

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

  1. Phase 0: Feasibility of Phase 0 study in patient population

    Number of patients to complete all planned investigations and procedures

    Measured: 14 months

  2. Phase 0: pharmacokinetic analysis of tumour tissue

    Total and unbound AB-218 in tumour tissue

    Measured: 4 weeks

  3. Phase 0: pharmacokinetic analysis of cerebrospinal fluid (CSF)

    Total and unbound AB-218 in CSF

    Measured: 4 weeks

  4. Phase 2: Number of Adverse events

    Number of adverse events (AEs) according to NCI CTCAE v 5

    Measured: up to 30 days after last study dose

  5. Phase 2: Incidence of drug related adverse events

    Drug related adverse events

    Measured: up to 30 days after last study dose

  6. Phase 2: Incidence of dose limiting toxicity

    Dose limiting toxicity events

    Measured: up to 30 days after last study dose

Secondary outcomes (9)

  1. Phase 0: Incidence of treatment emergent Adverse events

    Treatment emergent adverse events (AEs) according to NCI CTCAE v 5

    Measured: during 1 cycle of AB-128, prior to maximal resection (4 weeks)

  2. Phase 0: Safety of planned craniotomy and resection after stereotactic biopsy and treatment with AB-218

    30-day morbidity and mortality post surgery

    Measured: 30 days after maximal resection

  3. Phase 0: Pharmacodynamic (PD) analysis of AB-218 in tumour

    Changes in 2-hydroxyglutarate (2-HG) levels in tumour

    Measured: after maximal resection (4 weeks), at progression (optional)

  4. Phase 0: Pharmacodynamic (PD) analysis of AB-218 in cerebrospinal fluid (CSF)

    Changes in 2-hydroxyglutarate (2-HG) levels in cerebrospinal fluid (CSF)

    Measured: after maximal resection (4 weeks), at progression (optional)

  5. Phase 0: Pharmacodynamic (PD) analysis of AB-218 in plasma

    Changes in 2-hydroxyglutarate (2-HG) levels in plasma

    Measured: after maximal resection (4 weeks), monthly during treatment, at progression (optional)

  6. Phase 0: anti-tumour activity

    Objective response (LGG RANO assessment)

    Measured: 4 weeks

  7. Phase 0: Identify factors that can improve the patient experience quality of the service provided to participants using Research Participant Perception Survey short form (RPPS)

    Understanding the patients' perspective on the peri-operative design and satisfaction with study procedures

    Measured: 4 months post op

  8. Phase 2: Identify factors that can improve the patient experience quality of the service provided to participants using Research Participant Perception Survey short form (RPPS)

    Understanding the patients' perspective on the peri-operative design and satisfaction with study procedures

    Measured: 4 months post op

  9. Phase 2: anti-tumour activity

    Objective response (LGG RANO assessment)

    Measured: 12 weekly until progression

Timeline

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

  1. First posted13 Oct 2022
  2. Study start11 Oct 2022
  3. Primary completion26 Mar 2025
  4. Study completion26 Mar 2025

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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Phase 0 'window of opportunity'/perioperative (Part A) followed by Phase 2 adjuvant treatment
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05577416
Sponsor's protocol ID
2022.003
Acronym
AB-218-IIT-201
Status last verified
Mar 2026
First submitted
19 Sep 2022
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

  • Cain SA, Topp M, Rosenthal M, Tobler R, Freytag S, Best SA, Whittle JR, Drummond KJ. A perioperative study of Safusidenib in patients with IDH1-mutated glioma. Future Oncol. 2024;20(33):2533-2545. doi: 10.1080/14796694.2024.2383064. Epub 2024 Aug 14.

    PubMed 39140289

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Biopsy, Part A: Safusidenib Erbumine and Surgery (maximal resection) in people with Glioma, run by Melbourne Health at 1 site in Australia.

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 10 inclusion and 12 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: finished, as of the sponsor's last update on 18 Mar 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 Australia. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 0: Feasibility of Phase 0 study in patient population (time frame: 14 months). The study lists 6 primary outcomes in all. 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 NCT05577416, 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 18 Mar 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