Gene Therapy for Brain Cancer
(ADePT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new gene therapy called TGX-007 for people with glioblastoma, a type of brain cancer. The goal is to determine its safety and effectiveness. TGX-007 uses a harmless virus to deliver two treatments: one targets cancer cells, and the other boosts the immune system to fight the cancer. The trial seeks participants who have recently been diagnosed with glioblastoma or whose cancer has returned, and who can undergo surgery and chemoradiotherapy. Participants will receive the gene therapy directly into the tumor and take an oral medication before standard surgery.
As a Phase 1 trial, this research focuses on understanding how TGX-007 works in people, offering participants the chance to be among the first to receive this innovative treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot use immunosuppressant or immune modulatory medicines within 28 days before starting the trial. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that TGX-007 is likely to be safe for humans?
Research has shown that TGX-007, a gene therapy for brain cancer, remains in the early testing stages, providing limited information about its safety in humans. It uses an adeno-associated virus (AAV) to deliver the therapy, a method generally considered safe and used in other gene therapies. In animal studies, TGX-007 demonstrated promising results, achieving a high cure rate in mice without major safety issues.
As the trial is in its early phases, researchers focus primarily on finding a safe dose and closely monitor for any side effects. Currently, detailed information about side effects in humans is unavailable. The treatment also includes valacyclovir, an approved drug that is usually well-tolerated.
Overall, while TGX-007 has shown promise in early research, the current trial will help determine its safety and tolerability for people with glioblastoma.12345Why do researchers think this study treatment might be promising for brain cancer?
Most treatments for brain cancer, like chemotherapy and radiation, work by targeting rapidly dividing cells but often damage healthy cells too. TGX-007 is unique because it uses gene therapy to deliver genetic material directly into tumor cells, aiming to kill cancer cells with more precision and fewer side effects. Researchers are excited about TGX-007 because it represents a targeted approach, potentially reducing harm to healthy tissues and improving outcomes for patients with high-grade gliomas and recurrent glioblastoma. By homing in on cancer cells specifically, this method could change the game in treating aggressive brain cancers.
What evidence suggests that TGX-007 might be an effective treatment for glioblastoma?
Research has shown that TGX-007, a gene therapy for brain cancer, could effectively treat glioblastoma. In studies with mice, 85% of those treated with TGX-007 were cured, while all untreated mice died within 50 days. This trial will explore TGX-007 in different contexts: a dose-finding phase and expansions for newly diagnosed high-grade glioma and recurrent glioblastoma patients. This treatment uses a safe virus to deliver two important components: one that converts a harmless substance into an active drug to kill tumor cells, and another that strengthens the immune system to fight the cancer. Although these results come from early research, they suggest TGX-007 may effectively target and destroy cancer cells while also boosting the body's natural defenses.12678
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
Citations
DDDR-48. An AAV-1 mediated dual-payload gene therapy for ...
85% of mice treated with TGX-007 were cured; all control mice died within 50 days. Treated mice were re-exposed to tumorigenic cells at 20 weeks ...
Gene Therapy for Brain Cancer (ADePT Trial)
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 ...
2024 Achievements and 2025 Outlook
Lead Programme: Glioblastoma (GBM) – TGX-007. Curative preclinical results. Manufacturing milestone achieved. Ready to enter the clinic in 2025.
4.
braintumourresearch.org
braintumourresearch.org/blogs/latest-news/blog-new-trial-for-brain-tumour-patients-to-start-in-early-2026-what-is-it-and-how-will-it-work?srsltid=AfmBOorehyA72tofChwTAAI-8Erj0djs9tc7kOEMJvtyTyUt2ScGQpWQBlog: New trial for brain tumour patients to start in early 2026
Glioblastoma is one of the most difficult cancers to treat. It is incredibly aggressive with a prognosis of just 12-18 months. This new ...
5.
prnewswire.com
prnewswire.com/news-releases/viralgen-collaborates-with-trogenix-to-advance-aav-gene-therapy-for-glioblastoma-302445018.htmlViralgen collaborates with Trogenix to advance AAV gene ...
"Glioblastoma, the most common form of brain cancer, is a devastating disease with very poor prognosis and few treatment options for patients.
6.
viralgen.com
viralgen.com/news/viralgen-collaborates-with-trogenix-to-advance-aav-gene-therapy-for-gliobastomaViralgen collaborates with Trogenix to advance AAV gene ...
... TGX-007 is now advancing toward clinical evaluation, and, ultimately, to patients in need. “Glioblastoma, the most common form of brain cancer ...
7.
braintumourresearch.org
braintumourresearch.org/blogs/latest-news/blog-new-trial-for-brain-tumour-patients-to-start-in-early-2026-what-is-it-and-how-will-it-work?srsltid=AfmBOorYHmbRTfa9sNC2GkEPaenKK4uuATaw0dBiWzBeM6EiDPDl-TQZBlog: New trial for brain tumour patients to start in early 2026
This pioneering treatment is initially being tested in glioblastoma, with the aim of a clinical trial opening in early 2026. It is hoped that ...
8.
tessajowellbraincancermission.org
tessajowellbraincancermission.org/wp-content/uploads/2024/09/BTR-NTA-Non-confidential-summaries-1.pdfBTR-NTA Non-confidential summaries
of their therapies, TGX-007, reviewed by the BTR-NTA Committee. TGX-007 is a viral immunotherapy technology that uses synthetic super enhancers to control ...
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