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:

• Adults aged 18 or older at the time of giving consent to participate
• People who have been diagnosed with a Grade 3 or Grade 4 glioma (a type of brain tumour), confirmed by a tissue sample test
• People whose brain tumour has come back or continued to grow after previous treatment
• People who have had no more than two previous rounds of treatment for their condition
• People who finished radiotherapy (radiation treatment) at least 3 months before joining, unless the tumour has grown and the affected area was outside the radiation zone (confirm with trial site)
• People who have waited a sufficient period since their last cancer treatment before having the required baseline brain scan — the exact waiting period depends on the type of treatment previously received (confirm with trial site)
• People who have recovered from most or all side effects of previous treatments before starting the study
• People taking steroid medications (such as dexamethasone or prednisone) who are on a stable or reducing dose within certain limits for at least the 7 days before starting the study treatment
• People who experience seizures, but only if their seizures are well-controlled on a steady medication regimen
• People with a good general level of physical functioning (able to carry out daily activities with no or minimal limitations)
• People who are able to swallow tablets or capsules
• People with adequate blood counts and healthy liver and kidney function
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before the first dose, and must use highly effective contraception during the study and for at least 3 months after the last dose
• Men whose partners could become pregnant must be willing to use condoms combined with a second form of contraception during the study and for at least 3 months after the last dose

Who may not be able to join:

• People who are unable to have a contrast-enhanced MRI brain scan using a gadolinium-based dye (for example, due to an allergy or kidney concerns)
• People with a history of another cancer, unless complete remission was achieved at least 3 years before joining and no additional cancer treatment (other than certain hormone therapies or bone-strengthening medications) is needed during the study
• People with a known active or uncontrolled infection, or an unexplained fever above 38°C in the 3 days before starting the study treatment
• People who have had a major surgical procedure (unrelated to the tumour) or a serious injury within 28 days before signing consent
• People who have recently received an experimental treatment (one not yet approved by a regulatory authority) within 4 weeks or 5 half-lives — whichever is longer — before the baseline brain scan

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