Evaluating AB-218 in Patients with IDH1 Mutated Low Grade Glioma
A Phase 0/2 Study of AB-218 in Patients With IDH1 Mutated Low Grade Glioma
This study is testing a new drug called AB-218 in patients with a specific type of brain tumor to see if it helps shrink the tumor before surgery.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Melbourne Health Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT05577416 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the feasibility of using Safusidenib Erbumine (AB-218) in patients with IDH1 mutated low grade glioma who are scheduled for surgical resection. The study involves a single-arm, open-label Phase 0 design where participants will first undergo a biopsy, followed by a 28-day treatment cycle with the drug before surgery. After recovery, patients will continue receiving the treatment for up to 12 cycles, depending on their clinical benefit. The trial will measure the drug's pharmacokinetics, pharmacodynamics, and anti-tumor activity using established response criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed IDH1 mutated low grade glioma who are scheduled for surgical resection.
Not a fit: Patients requiring immediate definitive resection or those with multicentric tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with IDH1 mutated low grade glioma, potentially improving outcomes and quality of life.
How similar studies have performed: While this approach is novel in the context of IDH1 mutated low grade glioma, previous studies have shown promise in pre-treating glioblastoma patients with systemic therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Melbourne, Victoria
- Royal Melbourne Hospital — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Kate Drummond, Prof — Melbourne Health
- Study coordinator: Kate Drummond, Prof
- Email: AnHeart@wehi.edu.au
- Phone: +61 3 9345 2767
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.