NCT05577416

A Study of 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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Melbourne Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Glioma

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Patients will undergo stereotactic biopsy by craniotomy or burr hole.
DRUG	Part A: Safusidenib Erbumine	Part A: Safusidenib Erbumine orally 250 mg BID for 28 days.
PROCEDURE	Surgery (maximal resection)	Surgery: Maximal safe resection, within 24 hours of last dose of Safusidenib Erbumine.
DRUG	Part B: 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.

Timeline

• Start date: 2022-10-11
• Primary completion: 2025-03-26
• Completion: 2025-03-26
• First posted: 2022-10-13
• Last updated: 2026-03-18

Locations

1 site across 1 country: Australia