Phase 1 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 who are willing to sign a consent form agreeing to take part in the study.
• People who have been diagnosed with a specific aggressive brain tumour (CNS WHO grade 4 glioma), confirmed by a tissue biopsy, whose tumour has come back or grown after standard treatment as shown on an MRI scan, and for whom surgery is not planned.
• People aged 18 or older, of any gender.
• People whose doctors expect them to live for at least 12 weeks.
• People who have at least one measurable tumour in the brain, assessed using a specific measurement system called RANO criteria.
• People who have a good general level of functioning, as measured by a scale called the Karnofsky Performance Scale (KPS score of 70 or above), meaning they are able to care for themselves and carry out some normal activity.
• People whose blood, liver, and kidney test results are within acceptable ranges before joining, and who have not needed blood transfusions, platelet transfusions, or growth factor injections in the week before starting treatment (specific thresholds apply — confirm with trial site).
• People of childbearing potential, or people whose partners are of childbearing potential, who agree to use effective contraception from signing the consent form until 6 months after the last dose of study treatment.

Who may not be able to join:

• People who have previously received any treatment targeting TIGIT, PD-1, PD-L1, or CTLA-4 (certain types of immunotherapy).
• People who currently have another cancer requiring active treatment, with the exception of certain fully treated skin cancers or early-stage cervical conditions.
• People who have an autoimmune disease, a history of autoimmune disease, or related symptoms.
• People who are unable to have an MRI scan, for example due to a pacemaker, non-removable metal dental work, or severe claustrophobia.
• People who have received chemotherapy, radiotherapy, immunotherapy, targeted therapy, or other anti-tumour treatments within 28 days before the first study dose (or within a shorter window depending on the specific drug), or who have taken part in another clinical trial within 28 days before the first study dose. People who received a specific type of chemotherapy drug called nitrosourea within the past 42 days also cannot join.
• People whose tumour affects the brainstem, spinal cord, or has spread to the membranes surrounding the brain and spinal cord.
• People who have taken corticosteroid medicines (such as dexamethasone at a daily dose above 3 mg, or an equivalent amount of another steroid) within the month before joining the trial.
• People who still have significant side effects (grade 2 or higher on a standard toxicity scale) from previous cancer treatments, unless those side effects are considered safe by the treating doctor, such as hair loss, certain nerve-related effects, or a thyroid condition managed with medication.
• People who have received a live vaccine within 4 weeks before the first study dose, or who plan to receive one during the trial.
• People who currently have an active infection, such as a bacterial infection, tuberculosis, or a lung infection.
• People who have active or uncontrolled hepatitis B, hepatitis C, HIV, or a syphilis infection (confirm specific testing requirements with trial site).
• People with poorly controlled heart conditions, including uncontrolled high blood pressure, unstable chest pain, a heart attack within the past 6 months, or certain abnormal heart rhythms.
• People with more severe heart failure, classified as grade III or IV by a standard heart function scale (NYHA classification).
• People who have a known allergy to the study drug or its ingredients, to antibody-based medicines, or to certain other therapeutic proteins, or who have had a severe allergic reaction in the past.
• People with a diagnosed neurological or psychiatric condition, such as dementia, that may make it difficult to follow the trial requirements.
• People with epilepsy and/or raised pressure in the brain that cannot be adequately controlled with medication.
• Women who are pregnant or breastfeeding.
• People whom the trial doctors consider unsuitable for any other reason.

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