Phase 2 Brain Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged between 18 and 70 years old
• People whose general health and ability to carry out daily activities meets a minimum level of functioning (confirm with trial site)
• People newly diagnosed with a high-grade brain tumour in one specific area on one side of the brain, confirmed by MRI
• People with a returning brain tumour (glioblastoma/GBM) that has shown its first sign of growth on scans, who have previously been treated with standard surgery and combined radiation and chemotherapy, and who have a confirmed past diagnosis of GBM
• Newly diagnosed patients who are considered suitable for six weeks of combined radiation and chemotherapy, followed by six months of additional chemotherapy (known as the Stupp protocol)
• People for whom surgery to reduce the tumour is recommended as part of their care
• People who are able to swallow tablets or capsules
• People who are willing to avoid live vaccines during the study
• People whose organs (such as kidneys and liver) are functioning adequately (confirm with trial site)
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before the study start date
• All participants must agree to either avoid sexual activity that could lead to pregnancy, or use highly effective contraception throughout the study
• People who are willing and able to give their informed consent to take part

Who may not be able to join:

• People who are pregnant, breastfeeding, or planning to become pregnant during the study
• People with a weakened immune system, or an active autoimmune disease that requires ongoing medical treatment
• People with an active viral, bacterial, or fungal infection requiring antiviral or antibiotic treatment within 7 days before surgery
• People who have received a live vaccine within 28 days before the study start date
• People who have used medicines that suppress or alter the immune system within 28 days before the study start date
• People with a history of tuberculosis, or whose chest X-ray or CT scan shows signs of a past tuberculosis infection
• People who have previously received gene therapy treatment
• People with a significant history of a brain or nervous system disorder that the investigator considers would prevent safe participation (confirm with trial site)
• People who have had major surgery within 28 days before the study start date (a small biopsy procedure is permitted)
• People with a known allergy or medical reason preventing the use of valaciclovir, gadolinium, or the components of the study drug TGX-007
• People who are unable to have an MRI scan with gadolinium contrast dye
• People with any condition expected to interfere with the planned timing of their surgery
• People who have had a non-brain tumour cancer within the past 3 years (with some exceptions for certain treated skin, cervical, or prostate cancers — confirm with trial site)
• People with any other significant illness or condition that the investigator believes could put them at risk or affect their ability to participate
• People who have taken part in another clinical trial involving an experimental treatment within the past 12 weeks, or within 5 half-lives of that treatment, whichever is longer
• People for whom personal, family, social, or geographic circumstances may make it difficult to follow the study schedule and requirements
• People who are unwilling to allow their general practitioner to be informed of their participation in the study
• For newly diagnosed patients only: People who have received any prior treatment for glioma, or who intend to use tumour treating fields during the study
• For patients with a returning tumour only: People who still have side effects from previous cancer treatments or radiotherapy that have not improved to a mild level, or who intend to use tumour treating fields during the study

Important: Always verify eligibility with the trial site directly before applying.