CompletedEarly Phase 1

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

Australia14 participantsStarted 2022-10-11

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. ECOG performance score 0-1
. Life expectancy of at least 24 months, in the opinion of the investigator

Exclusion criteria

. Patients who require immediate definitive resection due to degree of mass effect or symptoms
. Multicentric / multifocal tumour
. Tumour involves cerebellum or brainstem

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Phase 0: Feasibility of Phase 0 study in patient population

Timeframe: 14 months

Phase 0: pharmacokinetic analysis of tumour tissue

Timeframe: 4 weeks

Phase 0: pharmacokinetic analysis of cerebrospinal fluid (CSF)

Timeframe: 4 weeks

Phase 2: Number of Adverse events

Timeframe: up to 30 days after last study dose

Phase 2: Incidence of drug related adverse events

Timeframe: up to 30 days after last study dose

Phase 2: Incidence of dose limiting toxicity

Timeframe: up to 30 days after last study dose

Trial details

NCT IDNCT05577416

SponsorMelbourne Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-26

View on ClinicalTrials.gov More Glioma trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. ECOG performance score 0-1
. Life expectancy of at least 24 months, in the opinion of the investigator

Exclusion criteria

. Patients who require immediate definitive resection due to degree of mass effect or symptoms
. Multicentric / multifocal tumour
. Tumour involves cerebellum or brainstem

What they're measuring

Phase 0: Feasibility of Phase 0 study in patient population

Timeframe: 14 months

Phase 0: pharmacokinetic analysis of tumour tissue

Timeframe: 4 weeks

Phase 0: pharmacokinetic analysis of cerebrospinal fluid (CSF)

Timeframe: 4 weeks

Phase 2: Number of Adverse events

Timeframe: up to 30 days after last study dose

Phase 2: Incidence of drug related adverse events

Timeframe: up to 30 days after last study dose

Phase 2: Incidence of dose limiting toxicity

Timeframe: up to 30 days after last study dose