Phase 1 Brain Cancer Trial, Recruiting

Written by an AI model from the 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 who are able to understand and sign a consent form before any study procedures begin
• People who are 18 years of age or older, whether male or female
• People who have been diagnosed with glioblastoma (a type of brain tumour) confirmed by laboratory testing of tissue, following brain surgery, based on the 2021 WHO definition — tumours located in the lower back part of the brain are not included
• People who have had surgery for glioblastoma but have not yet received any drug treatment or radiation therapy for this condition
• People who have a Karnofsky Performance Status score of 70 or higher, which is a measure of how well a person is able to carry out daily activities (confirm with trial site)
• People who are planned to start a standard combination of chemotherapy and radiation therapy (known as the Stupp regimen) within 3 to 6 weeks after their brain surgery
• People whose blood counts and organ function meet the required levels at the screening stage, including healthy enough levels of white blood cells, platelets, haemoglobin, liver enzymes, and kidney function (confirm specific values with trial site)
• People who have at least 6 unstained tissue slides or a stored tissue block available from a previous biopsy or surgery
• People who are willing and able to follow all study requirements, including radiation safety guidelines such as possible hospital stays or periods of isolation to protect others from radiation exposure
• People who agree to take adequate precautions to prevent pregnancy during the study, to avoid potential radiation-related risks to an unborn child
• Female participants must have a negative pregnancy test at screening and on the day of dosing, and must not be breastfeeding

Who may not be able to join:

• People who are unable to give signed consent to participate
• People who have previously received any treatment for a glioma (brain tumour) other than surgery
• People who are unable to have a contrast-enhanced MRI scan
• People who plan to use tumour-treating fields (a type of electrical device therapy) before their disease gets worse
• People who have a history of certain long-lasting infections — such as tuberculosis, or widespread fungal or parasitic infections — that may be made worse by steroid treatment
• People with a known allergy to temozolomide (a chemotherapy drug used in this study), any ingredient in the study medication, or any human protein, peptide, or antibody given through a vein
• People with blood clotting conditions that would make it unsafe to have a catheter or similar invasive procedure
• People who have previously been diagnosed with phenylketonuria (an inherited condition affecting how the body processes a certain amino acid)
• People with any medical condition that the trial doctor believes could interfere with participation or pose a risk to their health
• People who have had major surgery (such as heart, chest, or abdominal surgery) or serious injury within 3 weeks before receiving the study treatment — surgery on the brain tumour itself is not counted as an exclusion
• People who are pregnant, breastfeeding, or planning to become pregnant during the study
• People who require ongoing, high-dose steroid or other immune-suppressing medication on a long-term basis — occasional use of steroids for short-term reactions is not an exclusion
• People with active, uncontrolled infections or other serious illnesses that the trial doctor believes would put them at undue risk or prevent them from following the study requirements — people living with HIV may still be considered if they are on a stable anti-retroviral treatment
• People who currently have another cancer, unless they have been free of that cancer without any treatment for at least 2 years
• People who have used growth factors or immune-modifying agents within 7 days before receiving the study treatment
• People with serious wounds, ulcers, or bone fractures that have not healed
• People who need to continue receiving other cancer treatments at the same time as the study treatment
• People who have taken part in another clinical trial involving an investigational medication within 90 days before the planned start of this study
• People with uncontrolled Hashimoto's thyroiditis or Graves' disease (thyroid conditions)
• People who still have unresolved side effects of Grade 1 or higher from their brain surgery at the time of joining the trial (confirm with trial site)

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