An Early Phase 1 interventional study of Biopsy and Part A: Safusidenib Erbumine in Glioma, sponsored by Melbourne Health. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Melbourne Health · Early Phase 1, Interventional, and Treatment
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.
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
1,452 studies on the registry are indexed under Glioma; 349 are open to participants now.
This study's enrollment of 14 is below the median of 32 across 1,075 interventional studies indexed under Glioma.
Browse Glioma studies →Melbourne Health is the lead sponsor of 59 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from participation in the study:
Other general criteria including:
i) abnormalities ii) significant comorbidity or infection iii) Prior iv) Recent surgery v) Known allergy or sensitivity to any of the in the product vi) no contraindicated concomitant medications
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Part A: Peri-operative treatment (Phase 0); Part B: Post operative adjuvant therapy (phase 2)
Procedure: Biopsy · Drug: Part A: Safusidenib Erbumine · Procedure: Surgery (maximal resection) · Drug: Part B: Safusidenib Erbumine
Patients will undergo stereotactic biopsy by craniotomy or burr hole.
Part A: Safusidenib Erbumine orally 250 mg BID for 28 days.
Surgery: Maximal safe resection, within 24 hours of last dose of Safusidenib Erbumine.
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.
Phase 0: Feasibility of Phase 0 study in patient population
Number of patients to complete all planned investigations and procedures
Time frame: 14 months
Phase 0: pharmacokinetic analysis of tumour tissue
Total and unbound AB-218 in tumour tissue
Time frame: 4 weeks
Phase 0: pharmacokinetic analysis of cerebrospinal fluid (CSF)
Total and unbound AB-218 in CSF
Time frame: 4 weeks
Phase 2: Number of Adverse events
Number of adverse events (AEs) according to NCI CTCAE v 5
Time frame: up to 30 days after last study dose
Phase 2: Incidence of drug related adverse events
Drug related adverse events
Time frame: up to 30 days after last study dose
Phase 2: Incidence of dose limiting toxicity
Dose limiting toxicity events
Time frame: up to 30 days after last study dose
Phase 0: Incidence of treatment emergent Adverse events
Treatment emergent adverse events (AEs) according to NCI CTCAE v 5
Time frame: during 1 cycle of AB-128, prior to maximal resection (4 weeks)
Phase 0: Safety of planned craniotomy and resection after stereotactic biopsy and treatment with AB-218
30-day morbidity and mortality post surgery
Time frame: 30 days after maximal resection
Phase 0: Pharmacodynamic (PD) analysis of AB-218 in tumour
Changes in 2-hydroxyglutarate (2-HG) levels in tumour
Time frame: after maximal resection (4 weeks), at progression (optional)
Phase 0: Pharmacodynamic (PD) analysis of AB-218 in cerebrospinal fluid (CSF)
Changes in 2-hydroxyglutarate (2-HG) levels in cerebrospinal fluid (CSF)
Time frame: after maximal resection (4 weeks), at progression (optional)
Phase 0: Pharmacodynamic (PD) analysis of AB-218 in plasma
Changes in 2-hydroxyglutarate (2-HG) levels in plasma
Time frame: after maximal resection (4 weeks), monthly during treatment, at progression (optional)
Phase 0: anti-tumour activity
Objective response (LGG RANO assessment)
Time frame: 4 weeks
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
Time frame: 4 months post op
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
Time frame: 4 months post op
Phase 2: anti-tumour activity
Objective response (LGG RANO assessment)
Time frame: 12 weekly until progression
Phase 2: Survival
Progression free survival (PFS)
Time frame: 30 days after last study dose
Phase 2: Survival
Overall survival (OS)
Time frame: 30 days after last study dose
Phase 2: Survival
Time to treatment failure (TTF)
Time frame: 30 days after last study dose
Phase 0: Change in tumour volume in response to Safusidenib
Volumetric analysis of post biopsy and pre-op MRI images
Time frame: 4 weeks
Phase 2: Change in tumour volume in response to Safusidenib
Volumetric analysis of MRI images during adjuvant treatment
Time frame: 12 weekly until progression
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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