ClinicaliQ Trial Snapshot
- Study of an AAV Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma — Recruiting • Phase I • Oncology • NCT07346144.
- What is being tested: TGX-007, an AAV-mediated dual-payload gene therapy delivered directly into brain tumours to establish safety, optimal biological dose, and efficacy in patients with newly diagnosed or recurrent glioblastoma.
- Patient eligibility overview: The trial recruits adult patients with high-grade glioma, specifically those with newly diagnosed or recurrent glioblastoma who meet standard oncological criteria for enrolment (full eligibility determined by individual trial sites).
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- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
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What This Trial Is Studying
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…
Eligibility Snapshot
- : * Aged 18-70 years * Karnofsky performance status ≥70 * Newly diagnosed patients: Unifocal, unilateral high-grade glioma based on MRI * Recurrent patients: First radiological progression (as determined by the multidisciplinary team [MDT]) of GBM previously treated with standard care surgery and chemoradiotherapy. Patients must have a prior confirmed histological/molecular diagnosis of GBM * Newly diagnosed patient: suitable for six weeks of chemoradiotherapy followed by six months of adjuvant temozolomide (Stupp protocol) * Debulking surgery is indicated for optimal patient care * Able to swallow oral medication * Willing to avoid live vaccines * Adequate organ function * Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to Day 0. * All patients must agree to practice true abstinence or to use highly effective contraception * Patient is willing and able to give informed consent for participation in the study
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.