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Experimental drug AB-218 tested in brain tumor patients

NCT ID NCT05577416

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called AB-218 (safusidenib) in 14 adults with a specific type of slow-growing brain tumor (IDH1 mutated low grade glioma) who were already scheduled for surgery. The goal was to see if it's possible to measure how much drug gets into the tumor and to check for safety. Participants took the drug for 28 days before surgery, and some continued afterward to monitor side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Safusidenib Erbumine (AB-218)
What this could lead to
If successful, this could help determine whether AB-218 reaches brain tumors effectively and is safe, potentially leading to a new treatment option for IDH1 mutated low grade glioma.
What could go wrong
This is an early-phase trial with only 14 participants, so results may not apply to all patients. The drug may not show enough benefit or could cause side effects, and further larger studies are needed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

14 people

The number who actually took part.

Started

Oct 2022

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically confirmed LGG or new diagnosis of LGG based on MRI 2. Tumours suitable for biopsy and safe for maximal resection in the opinion of the treating neurosurgeon 3. Patients who in the consensus of the treating neurosurgeon require resection of the brain tumour. 4. Patients who do not require immediate definitive resection of the brain tumour in the opinion of the treating neurosurgeon 5. Measurable and/or evaluable disease as per LGG-RANO criteria 6. Age ≥ 18 years of age. 7. ECOG performance score 0-1 8. Life expectancy of at least 24 months, in the opinion of the investigator 9. Adequate haematological, renal and hepatic function 10. Reproductive and contraception criteria as prescribed Exclusion Criteria: Patients who meet any of the following criteria will be excluded from participation in the study: 1. Patients who require immediate definitive resection due to degree of mass effect or symptoms 2. Multicentric / multifocal tumour 3. Tumour involves cerebellum or brainstem 4. Patients who have undergone surgery for glioma within 24 months of study enrolment 5. Patients who have received prior chemotherapy and / or radiation for a diagnosis of glioma 6. Patients with contraindications to MRI or unwilling to undergo MRI 7. History of central nervous system bleeding as defined by stroke within 6 months before enrolment 8. Evidence of acute intracranial / intra-tumoural haemorrhage, except for participants with stable grade 1 haemorrhage 9. 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 10. 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Royal Melbourne Hospital

    Melbourne, Victoria, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.