Summary
This research project is testing an experimental treatment for people with glioblastoma that has returned or progressed after standard-of-care therapy.
The experimental treatment being investigated in this study is called EGFR-targeted E-EDV-Dox. The EDV is a delivery vehicle derived from non-disease-causing Salmonella bacteria that carries the chemotherapy drug doxorubicin directly to the tumour via the bloodstream.
E-EDV-Dox is combined with another investigational EDV product that is designed to stimulate the body’s immune system to fight the cancer. This product consists of non-targeted EDVs carrying alpha-galactosylceramide (αGC), referred to as EDV-GC. The combination of these two products is known as E-EDV-Dox/GC.
Study details
In Phase I of the study, a safety assessment will be performed in 6 participants. In Phase II, the recommended dosing regimen identified in Phase I will be expanded to include up to 40 participants.
The first treatment cycle will involve twice-weekly visits over 4 weeks, during which a single dose will be administered at each visit (8 doses total). This will be followed by weekly visits for a further 3 weeks, during which 2 doses of the investigational product will be administered 90 minutes apart at each visit (6 doses total).
Doses of E-EDV-Dox/GC will be administered intravenously (via IV) over approximately 10 seconds. In week 8, tumour burden will be reassessed radiologically.
Subsequent treatment cycles will consist of weekly visits over 7 weeks, with 2 doses administered 90 minutes apart at each visit. Each 7-week treatment period will be followed by a treatment-free week during which tumour burden will again be radiologically assessed (week 8).
Treatment may continue until either the participant or investigator decides it is appropriate to stop treatment, for example due to serious side effects or continued disease progression.
It is hoped that the findings from this study will help determine the safety and efficacy of E-EDV-Dox/GC treatment for recurrent glioblastoma.