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

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

October 11, 2022

Primary Completion Date

December 1, 2024

Study Completion Date

December 1, 2025

Conditions
Glioma
Interventions
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.

Trial Locations (1)

Unknown

RECRUITING

Royal Melbourne Hospital, Melbourne

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Walter and Eliza Hall Institute of Medical Research

OTHER

collaborator

AnHeart Therapeutics Inc.

INDUSTRY

lead

Melbourne Health

OTHER