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
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from participation in the study:
Other general criteria including:
i) 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
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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