Overview
A Study of AB-218 in Patients With IDH1 Mutated Low Grade Glioma
Status:
Recruiting
Recruiting
Trial end date:
2025-12-01
2025-12-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Early Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Melbourne HealthCollaborators:
AnHeart Therapeutics Inc.
Walter and Eliza Hall Institute of Medical Research
Criteria
Inclusion Criteria:1. Patients will have a radiological diagnosis of LGG or a previously confirmed LGG and
be planned for elective, non-urgent resection of the tumour
2. Patients who do not require urgent resection for mass effect, cerebral oedema or
hydrocephalus in the opinion of the treating neurosurgeon
3. Tumour size 2 - 5 cm
4. Measurable and/or evaluable disease as per LGG-RANO criteria
5. Willing to undergo planned surgical procedures
6. Routine trial inclusion criteria
1. Adults ≥ 18 < 40 years of age
2. ECOG performance score 0 - 1
3. Life expectancy of at least 24 months
4. Haematological and renal function as prescribed
5. Hepatic function with prescribed limits
6. 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 urgent resection due to degree of mass effect, oedema,
hydrocephalus or symptoms
2. Patients who have received chemotherapy or radiation for the diagnosis of LGG
3. Tumour involves cerebellum or brainstem
4. Routine trial exclusion criteria
1. Any significant Intracranial bleeding in the opinion of the principal
investigator
2. Prior malignancy
3. Significant co-morbidity
4. ECG abnormalities
5. Recent surgery
6. Known allergy or sensitivity to any of the excipients in the investigational
product