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 who are 18 years of age or older.
• People who are able to understand what the study involves and have signed an approved consent form.
• People who have been diagnosed with a specific type of brain tumour called IDH wild-type glioblastoma (GBM), gliosarcoma, or epithelioid glioblastoma, confirmed by laboratory testing of tumour tissue. IDH-mutant glioma does not meet this criterion.
• People whose brain tumour has come back or continued to grow after receiving standard radiation treatment and temozolomide chemotherapy (if their tumour has a certain genetic marker called MGMT methylation), or after radiation alone (if the tumour does not have that marker).
• People who have not received any additional treatment for their returning tumour beyond the standard first treatment.
• People who may have had surgery for a returning tumour, provided the surgery was at least 2 weeks before joining the trial and an MRI was done within 48 hours after surgery.
• People who have not had radiotherapy in the 3 months before their tumour was confirmed to have progressed.
• People who are willing to avoid using a device called Optune (tumour-treating field therapy) during the trial.
• People who have been on a stable or decreasing dose of steroids for at least 7 days before their baseline MRI scan.
• People who have recovered from side effects of previous treatments, with most side effects at a mild level or gone entirely (some nerve-related side effects and hair loss may still be present).
• People who are reasonably physically functional in daily life (confirm with trial site regarding the specific performance scale used).
• People who have a life expectancy of at least 6 months.
• People whose liver function blood test results are within an acceptable range.
• People whose kidney function is within an acceptable range.
• People whose blood counts (white blood cells, platelets, and haemoglobin) are within acceptable levels without needing blood-support treatments.
• Women who could become pregnant must have a negative pregnancy blood test before joining, and all participants must agree to use effective contraception from the time of joining until 6 months after the last dose.
• People who have tumour tissue available for central laboratory review and biomarker testing.
• People who have measurable tumour (either returning or remaining) visible on imaging at the time of joining.
• People whose tumour tissue shows a high level of a protein called Trop-2 (confirmed by a specific central laboratory review).

Who may not be able to join:

• People who have previously been treated with bevacizumab or other medicines that target a pathway called VEGF.
• People who are currently taking warfarin or similar blood-thinning medicines and are unable to switch to a different type of blood thinner before starting the trial.
• People who have signs of active bleeding inside the brain or tumour on recent scans (minor, resolving bleeding may be acceptable — confirm with trial site).
• People who are unable to have an MRI scan (for example, those with a pacemaker).
• People who have taken certain seizure medications that affect liver enzymes within the past 14 days (confirm with trial site for specific medication names).
• People who are pregnant or breastfeeding.
• People who have certain serious ongoing health conditions, including poorly controlled high blood pressure, a wound or fracture that is not healing, significant heart rhythm problems, untreated underactive thyroid, an unhealed abscess in the rectal area, an uncontrolled active infection, heart failure or unstable chest pain within the past 3 months, any history of abnormal heart rhythm or heart block, or a stroke or mini-stroke within the past 6 months.
• People who have previously received certain non-standard forms of radiation therapy (such as radiation implants or radioactive injections), though a type called stereotactic radiosurgery may be acceptable (confirm with trial site).
• People who have received certain other cancer treatments too recently before joining — the required waiting periods vary depending on the type of treatment received (confirm with trial site).
• People who have previously been treated with carmustine wafers (a type of chemotherapy placed directly in the brain during surgery).
• People who have signs that the tumour has spread to the lining of the brain or spinal cord.

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