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 have been confirmed to have cancer through a tissue or cell sample test.
• Depending on which part of the trial a person joins: people with any solid tumour type (dose escalation phase); people with a brain cancer called glioblastoma, or GBM (Cohort 1); people with a specific type of breast cancer called triple-negative breast cancer, or TNBC (Cohort 2); or people with certain other solid tumour types selected by the trial committee based on research data (Cohort 3).
• People whose cancer has been shown on scans to be getting worse after at least one previous treatment for advanced or metastatic disease.
• People for whom no standard effective treatment options are available.
• People aged 18 to 80 years old.
• People who are well enough to carry out daily activities, as measured by standard medical scoring tools (confirm with trial site for exact score requirements).
• People who have recovered from most side effects of previous cancer treatments.
• People (other than GBM patients) who have tumour tissue that can be safely biopsied more than once.
• GBM patients who have been on a stable dose of steroid medication for more than 5 days before their baseline brain scan.
• People whose cancer can be measured on scans, according to standard medical guidelines (specific criteria differ for GBM and non-GBM patients — confirm with trial site).
• People whose blood cell counts, liver function, kidney function, and blood clotting levels all meet the minimum levels required by the trial (confirm with trial site for exact values).
• People who have signed a written consent form before any trial-related assessments begin.
• People with a life expectancy of at least 3 months.
• Women who could become pregnant must have a negative pregnancy test within 28 days before starting treatment, with a second confirmatory test within 72 hours before starting (if the first test was done earlier than that).
• Women who are not postmenopausal (defined as at least 12 months without a period, not caused by treatment) or permanently surgically sterile must agree to use a highly effective form of contraception throughout the trial and for at least 6 months after the last dose.
• Male participants must agree to either remain sexually abstinent or use a condom throughout treatment and for at least 90 days after the last dose.
• People who are able to take the study medication at home and use the provided device correctly.

Who may not be able to join:

• People who have had major surgery, chemotherapy, intensive radiotherapy, or other anti-cancer treatments within the 4 weeks before starting the trial.
• People (other than GBM patients) who have active cancer spread to the brain or spinal cord, unless that spread was fully treated and has been clinically stable for at least 3 months, and the person has been off steroids and anti-seizure medications before day one of treatment.
• GBM patients whose disease got worse within three months of their last radiotherapy treatment.
• People who are unable or unwilling to swallow medication.
• People with digestive system conditions that could significantly affect how the study medication is absorbed, such as uncontrolled nausea, vomiting, diarrhoea, or conditions affecting nutrient absorption.
• People who have had another cancer within the past 3 years, with the exception of certain adequately treated skin cancers or cervical carcinoma in situ.
• People with significant liver disease, including active hepatitis (viral, alcohol-related, or other types) or cirrhosis.
• People with a history of HIV infection, or active hepatitis B or C infection (some people with past or resolved hepatitis B or C may still be eligible — confirm with trial site).
• People who have had a severe infection within 4 weeks before joining the trial.
• People with a history of significant nervous system disorders or psychiatric conditions that, in the investigator's judgment, would affect their ability to consent or follow the study requirements.
• People with a heart pumping function below the minimum level required by the trial, as measured by heart scans.
• People with other severe or uncontrolled illness.
• People who have taken certain medications that affect how the liver processes drugs (CYP3A4/5 inhibitors) within a specific timeframe before starting, or who are unable or unwilling to avoid such medications during the trial (confirm with trial site for specific medications and timeframes).
• People with a known allergy or sensitivity to any component of the study drug.
• Women who are pregnant or breastfeeding.
• For people enrolling in France only: people who have had their personal liberty restricted, people not affiliated with a social security scheme, and adults under legal protection or unable to give informed consent.

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