Early 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 diagnosed with glioblastoma (GBM) according to 2021 WHO criteria whose cancer has continued to grow or returned after standard treatment, including surgery (or biopsy if full surgery was not safe) and combined chemotherapy and radiation therapy.
• People diagnosed with cancer that has spread to the brain (brain metastases) and requires surgery, whether or not previously treated, where the cancer elsewhere in the body is well-controlled or not detectable, as determined by their oncologist.
• People who have brain tumour tissue available from a previous biopsy or surgery, or who are able to provide a new biopsy sample.
• People who have at least one measurable tumour in the brain before surgery, visible on a scan with contrast dye, measuring at least 1 cm in two directions.
• People aged 18 or older at the time of signing consent.
• People who are reasonably functional in daily life, as measured by a standard medical scale called the ECOG scale (score of 0, 1, or 2) (confirm with trial site).
• People whose blood counts, liver, kidney, and other organ functions meet the specific healthy levels required by the trial, as confirmed by laboratory tests.
• Women who could become pregnant and who have a confirmed negative pregnancy blood test within 24 hours of the first treatment, and who agree to use a highly effective form of contraception for at least 28 days before treatment and for 8 months after the last dose.
• Women who are no longer able to become pregnant due to surgery, medical treatment, or natural menopause.
• Men who agree not to donate sperm during the study and for 5 months after the last dose, and who either abstain from heterosexual intercourse or use a condom, with their female partner also using an additional highly effective contraceptive method, from the start of the study through to 5 months after the last dose.
• Women who are able to become pregnant who agree not to breastfeed and not to donate eggs from the time of screening, throughout the study, and for 8 months after the last dose.
• People who are willing and able to follow all required visits, tests, and procedures throughout the study.
• People who understand the study information and have given written informed consent to participate voluntarily.

Who may not be able to join:

• People whose cancer has spread to the lining of the brain and spinal cord (leptomeningeal metastasis) or who have pressure on the spinal cord.
• People who are unable to have an MRI scan of the brain with contrast dye injected into a vein.
• People with a known active serious bacterial, fungal, or certain viral infection, including HIV, active hepatitis B or C.
• People who have had a serious infection in the 4 weeks before the first treatment dose, or who are currently on intravenous (IV) antibiotics within 2 weeks before the first dose (preventive antibiotic use is generally allowed).
• People with another severe or uncontrolled medical or psychiatric condition that, in the investigator's judgement, would make participation unsafe or make it difficult to follow the study requirements.
• People who still have significant side effects from previous treatments (above a mild level) at the time of starting the study, with some specific exceptions allowed (confirm with trial site).
• People who have previously received certain specific drugs that target a protein called B7-H3, including orlotamab, enoblituzumab, or similar agents.
• People who have taken an experimental drug within 4 weeks before the first dose.
• People who have received chemotherapy or other anti-cancer drugs within 14 days before the first dose.
• People who have received a monoclonal antibody treatment within 28 days before the first dose.
• People who have used immune-suppressing medications within 30 days before the first dose, or who require long-term steroid treatment (with some specific exceptions, confirm with trial site).
• People who have used certain medications that affect how the study drug is processed by the body (specific enzyme and drug-transport inhibitors) within 7 days before the first dose (confirm with trial site).
• People who have received a blood transfusion or certain blood-boosting injections within 14 days before enrollment.
• People who have had major surgery within 4 weeks before the first dose that, in the investigator's judgement, would create unacceptable safety risks.
• People who have had significant bleeding or a strong tendency to bleed within 1 month before the first dose.
• People with a known allergy or severe reaction to any component of the study drug (GSK5764227) or its ingredients, or a history of severe allergic reactions to similar types of drugs.
• People who have had a bone marrow transplant or solid organ transplant at any point in the past.
• People with current or past lung inflammation (interstitial lung disease or pneumonitis) that required high-dose steroid treatment.
• People with a history of moderate to severe lung disease.
• People with serious or poorly controlled high blood pressure, including a history of hypertensive crisis, or blood pressure readings at or above 160/100 mmHg during screening.
• People with significant heart rhythm problems, abnormal heart electrical readings (ECG), a high risk of certain heart rhythm disturbances, or a heart pumping function below 50%.
• People with severe or active heart or blood vessel conditions, such as a heart attack, unstable chest pain, heart failure, stroke, or serious blood clots in the past 3 to 6 months (timeframes vary by condition — confirm with trial site).
• People with a known active infection requiring treatment, or known HIV.
• People with laboratory evidence of hepatitis B infection at screening or within 3 months before the first dose.
• People with a positive hepatitis C antibody test at screening or within 3 months before the first dose (people with a past resolved hepatitis C infection may still be eligible if a follow-up test confirms the virus is no longer present).
• People with a positive hepatitis C RNA (virus) test at screening or within 3 months before the first dose.
• People with cirrhosis or unstable liver or bile duct disease, as determined by the investigator (some stable liver conditions are permitted — confirm with trial site).
• People with a history of autoimmune disease that required systemic (whole-body) treatment within the 2 years before screening (some replacement therapies such as thyroid hormone are not considered exclusionary — confirm with trial site).
• People with active kidney problems, such as requiring dialysis or any significant kidney condition that could affect safety.
• People who are unable or unwilling to follow all the required study activities and follow-up procedures.
• People who have received a vaccination or had a hypersensitivity reaction of any level within 4 weeks before the first dose.
• People who have received a live vaccine within 30 days before the first dose.
• People who are pregnant or currently breastfeeding.
• People who have donated more than 500 mL (approximately 1 pint) of blood or blood products within 1 month before the first dose.

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