Phase 2 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 have been diagnosed with a specific type of aggressive brain tumour (WHO grade 4, IDH wild-type glioma) that has come back after standard treatments such as radiation, chemotherapy, and/or tumour-treating fields, with no more than two recurrences confirmed.
• People who have had surgery or a laser heat treatment for the returned tumour before joining, provided at least 4 weeks have passed since the procedure and all complications have resolved.
• People who are at least 18 years old.
• People who are able to carry out most basic daily activities independently, as measured by a standard medical scale (Karnofsky Performance Status of 60% or higher).
• People whose blood counts and organ function fall within acceptable ranges, including adequate levels of white blood cells, platelets, haemoglobin, liver enzymes, kidney function, and protein in urine (confirm specific values with trial site).
• People whose heart rhythm measurement (QTcF) is below a certain threshold on an ECG, or whose alternative heart measurement (JT interval) meets criteria if a standard reading is not reliable (confirm with trial site).
• People who agree to use reliable contraception during the trial and for 4 months after treatment ends, and who agree to inform their treating doctor immediately if pregnancy occurs or is suspected during this time.
• People whose side effects from any previous cancer treatments have settled down to a mild level or disappeared before starting the trial, and who have waited at least 4 weeks after any major surgery.
• People whose steroid and anti-seizure medication doses have been stable or reducing for at least 7 days before starting the trial (for one specific treatment arm, a maximum daily steroid dose limit applies — confirm with trial site).
• People who are willing and able to give informed written consent, or who have a legally authorised representative who can do so on their behalf.

Who may not be able to join:

• People whose brain tumour got worse while they were receiving anti-VEGF treatments (such as bevacizumab), or who had to stop such treatments due to serious side effects (limited exceptions may apply — confirm with trial site).
• People who have received certain previous cancer treatments too recently, including investigational drugs, immunotherapy, chemotherapy, or targeted therapy, within specified time periods before joining (confirm exact timeframes with trial site).
• People who have used aspirin, anti-inflammatory pain medicines (such as ibuprofen), or blood-thinning medications at full treatment doses within 7 days before starting the trial (some low-dose preventive blood thinners may be allowed — confirm with trial site).
• People with a history of bleeding inside the brain or between the brain and skull, active bleeding disorders, stomach or bowel bleeding, abnormal connections between organs (fistulas), bowel obstruction, or inflammatory bowel disease.
• People with a history of serious unprovoked blood clots.
• People with certain heart or blood pressure conditions in the past 5 years, including heart failure, uncontrolled high blood pressure, past hypertensive crisis, pulmonary hypertension, heart attack, uncontrolled irregular heartbeat, or unstable chest pain (individual review may be possible — confirm with trial site).
• People with significant blood vessel problems, such as a large aortic aneurysm requiring surgery or a recent blood clot in an artery, within the past 6 months.
• People joining one specific treatment arm who have previously received experimental treatments targeting a particular immune protein called CD137 (4-1BB).
• People joining one specific treatment arm who have been on immune-suppressing medications (other than steroids) within 7 days before starting, unless certain exceptions apply (confirm with trial site).
• People who have previously had an organ transplant or bone marrow transplant.
• People joining one specific treatment arm who have received a live vaccine within 30 days before starting the trial.
• People with another current or past cancer that could affect the safety or results of this trial.
• People with a known allergy to substances chemically similar to the trial drugs CTX-009 or CTX-471.
• People with seizures that are not currently under control.
• People with serious uncontrolled illnesses such as active infections, uncontrolled high blood pressure, open wounds, or uncontrolled irregular heartbeat.
• People who are pregnant or breastfeeding, or who test positive on a pregnancy test within the required timeframe before starting.
• People living with HIV who are not on effective treatment or who have a detectable level of virus in their blood.
• People with chronic hepatitis B infection where the virus is still detectable despite treatment.
• People with a history of hepatitis C infection that has not been cured or is still detectable.

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