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

Sponsor
Melbourne Health
Study ID
NCT05577416
Phase
EARLY_PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Oct 13, 2022
Start date
Oct 11, 2022
Status verified
Mar 2026
Primary completion
Mar 26, 2025
Completion
Mar 26, 2025

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Safusidenib Erbumine (AB-218)
    Part A: Peri-operative treatment (Phase 0); Part B: Post operative adjuvant therapy (phase 2)

Primary Outcome Measure

Phase 0: Feasibility of Phase 0 study in patient population [ Time Frame: 14 months ]

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