The Ivy Brain Tumor Center at the Barrow Neurological Institute in the US has launched a Phase 0/Ib clinical trial of AstraZeneca’s AZD1390 in recurrent grade IV glioma patients.
AZD1390 is an inhibitor of Ataxia telangiectasia mutant (ATM) kinase.
The open-label, single-centre trial will enrol up to 21 subjects with a recurrent glioma who need re-radiation.
The Ben and Catherine Ivy Foundation and the Barrow Neurological Foundation’s individual donors are funding the trial.
Validating the blood-brain barrier penetration of AZD1390 and analysing if it can boost the efficacy of radiation therapy are the goals of the trial.
Subjects with tumours showing favourable pharmacokinetics (PK) response in the Phase 0 segment of the trial will advance to the expansion Phase Ib portion.
AZD1390 will be administered along with the standard of care fractionated radiotherapy in the Phase Ib portion.
Based on findings from the active Phase I multicentre trial of AZD1390 currently underway, the maximum safe dose-level of the drug will be chosen for the Phase 0 trial.
This Phase I trial is analysing the safety, tolerability and systemic pharmacokinetics of ascending doses of AZD1390 along with radiation therapy for brain cancer patients.
Ivy Brain Tumor Center chief operating officer and deputy director Shwetal Mehta said: “AZD1390 is a novel agent by AstraZeneca, specifically designed to cross the blood-brain barrier.
“The drug targets ATM kinase, an essential factor that promotes the repair of DNA double-strand breaks caused by radiation treatment.”
The US Food and Drug Administration introduced the Phase 0 trial approach in 2004 to expedite the assessment and approval process of drugs and enhance new therapies to enter the clinic.