Gene Therapy for Brain Cancer
(ADePT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to first define the Safety and Optimal Biological Dose (OBD) of study drug TGX-007 and to then further investigate the safety and efficacy in patients with newly diagnosed or recurrent Glioblastoma.
TGX-007 is a gene therapy drug delivered by a harmless adeno-associated virus (AAV) vector which delivers two combined therapeutic payloads to enable killing of proliferative cells and activation of an anti-tumour immune response. One is herpes simplex virus thymidine kinase (HSV-tk), which converts the pro-drug valaciclovir into an active drug that can kill tumour cells and the other is interleukin 12 (IL-12), which activates the body's immune system to recognise and fight the tumour.
Patients newly diagnosed with glioblastoma suitable for standard of care surgery and chemoradiotherapy or patients with recurrent glioblastoma suitable for further surgery may be eligible for the study. Patients will receive TGX-007 by a direct intratumoural injection and will then take the pro-drug valacyclovir orally for up to 21 days before proceeding to standard of care surgery.
The study is split into two phases. Phase I will treat patients at different dose levels of TGX-007 to identify the Optimal Biological Dose that will be used to further expand the study into Phase II. Phase II will expand the number of patients treated at the selected OBD to investigate how effective TGX-007 is at treating newly diagnosed and recurrent GBM.
Approximately 68 people aged 18-70 will take part in the study.
Are You a Good Fit for This Trial?
This trial is for adults aged 18-70 with high-grade glioma, either newly diagnosed and suitable for surgery and chemoradiotherapy or those experiencing their first recurrence after standard treatment. Participants must be able to take oral medication, avoid live vaccines, have good organ function, and women of childbearing age need a negative pregnancy test.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Finding
Phase I will treat patients at different dose levels of TGX-007 to identify the Optimal Biological Dose
Treatment
Patients receive TGX-007 by direct intratumoural injection and take valacyclovir orally for up to 21 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TGX-007
Trial Overview
The study tests TGX-007 gene therapy delivered via an AAV vector carrying HSV-tk to kill tumor cells and IL-12 to boost the immune response against tumors. It's given by injection into the tumor followed by valaciclovir pills. The trial has two phases: finding the best dose (Phase I) then testing its effectiveness (Phase II).
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Expansion in recurrent glioblastoma patients at the Optimal Biological Dose.
Expansion in Newly Diagnosed High Grade Glioma patients at the Optimal Biological Dose.
Dose escalation (with dose levels -1, 1, 2)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Trogenix ltd
Lead Sponsor
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