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New treatment option for Glioblastoma (GBM)
Official title Study of an AAV Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma
ClinicalTrials.gov ID: NCT07346144
What this study is testing
What is TGX-007?
TGX-007 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for glioblastoma (gbm).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Newly diagnosed patient: suitable for six weeks of chemoradiotherapy followed by six months of adjuvant temozolomide (Stupp protocol)
You likely can't join if
- Patient who is pregnant, lactating or planning pregnancy during the course of the study
- Immunodeficiency or active auto-immune disease requiring systemic therapy.
- Active viral, bacterial or fungal infection requiring concurrent antivirals or antibiotics within 7 days of surgery
- Live vaccine within 28 days prior to Day 0
- Use of immunosuppressant or immune modulatory medicines within 28 days prior to Day 0
- History of tuberculosis infection or chest x-ray or computed tomography (CT) chest showing radiological evidence of previous tuberculosis infection
See the full eligibility criteria
- 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...
- 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
- Patient who is pregnant, lactating or planning pregnancy during the course of the study
- Immunodeficiency or active auto-immune disease requiring systemic therapy.
- Active viral, bacterial or fungal infection requiring concurrent antivirals or antibiotics within 7 days of surgery
- Live vaccine within 28 days prior to Day 0
- Use of immunosuppressant or immune modulatory medicines within 28 days prior to Day 0
- History of tuberculosis infection or chest x-ray or computed tomography (CT) chest showing radiological evidence of previous tuberculosis infection
- Received previous treatment with a gene therapy
- Significant history of a central nervous system disorder that, in the opinion of the Investigator, would preclude enrolment
- Major surgery within 28 days prior to Day 0. A stereotactic biopsy is permitted
- Known hypersensitivity or contraindications to valaciclovir, gadolinium, or any excipients for TGX-007
- Contraindication to MRI with gadolinium
- Any condition expected to interfere with the intended timing of debulking surgery
- Previous non-glioma cancer within 3 years (other than treated squamous/basal cell skin cancer, treated early-stage cervical cancer or treated/biochemically stable, organ confined prostate cancer)
- Any other significant disease or disorder which, in the opinion of the Investigator, may put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability...
- Patients who have participated in another research study involving an investigational product in the past 12 weeks or 5 half-lives of the product
- Any psychological, familial, sociological, or geographical consideration potentially hampering compliance with the study protocol and follow up schedule; these conditions should be discussed with the patient before...
- Unwilling to allow their general practitioner, if appropriate, to be notified of participation in the study Newly diagnosed patients only:
- Any prior therapy for glioma
- Intended use of tumour treating fields Recurrent patients only:
- Prior toxicities from anti-cancer agents or radiotherapy which have not recovered to ≤Grade 1 severity
- Intended use of tumour treating fields
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
- Edinburgh, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States; Edinburgh, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.