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

NCT05577416 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Walter and Eliza Hall Institute of Medical Research

    collaborator OTHER

  • Nuvation Bio Inc.

    collaborator INDUSTRY

  • Melbourne Health

    lead OTHER

Principal Investigators

  • Kate Drummond, Prof · Melbourne Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-11
Primary Completion
2025-03-26
Completion
2025-03-26

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05577416 on ClinicalTrials.gov