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
• People who have been diagnosed (confirmed by tissue testing) with one of the following brain tumours: Glioblastoma (IDH-wildtype), or a Grade 3 or 4 astrocytoma with an IDH1 or IDH2 mutation (based on 2021 WHO classification)
• People whose tumour is measurable on scans (confirm with trial site for exact definition)
• People whose brain tumour has grown or returned after previous treatment with radiation and chemotherapy
• People with a life expectancy of at least 3 months
• People in a specific sub-group (Group C only) who are already planned to have radiosurgery and surgical removal of the tumour as part of their normal care
• People who are reasonably physically active and able to care for themselves, with limited or no restriction in daily activities (this is measured using a standard medical scale called ECOG Performance Status 0, 1, or 2 — confirm with trial site)
• People whose recent blood test results (taken within 15 days before joining) meet all of the following: sufficient red blood cells, white blood cells, infection-fighting cells (neutrophils), and platelets; liver function within acceptable ranges; and blood clotting results within acceptable ranges (or within the target range if already on blood-thinning medication)
• People whose kidneys are functioning at a sufficient level, based on a calculation using age, weight, and a blood test result (confirm with trial site for exact threshold)
• People who are not currently pregnant, confirmed by a negative pregnancy test taken within 7 days before joining (applies to those who could become pregnant)
• People who are willing to take protective measures against light exposure during the study and for two weeks after their last dose of the study drug WSD0628
• People who are willing and able to give written consent to participate
• People who are willing to return to the enrolling hospital or clinic for follow-up visits during the active monitoring phase of the study
• People who are willing to provide tissue samples for research purposes as required by the study

Who may not be able to join:

• People who are currently pregnant
• People who are currently breastfeeding
• People who could become pregnant, or who could father a child, and are not willing to use adequate contraception during the study
• People with serious uncontrolled illnesses, including active infections, unstable heart conditions, uncontrolled heart rhythm problems, or mental health or personal circumstances that would make it difficult to follow the study requirements
• People with certain heart-related concerns, including: a significantly prolonged heart electrical interval (QTc greater than 480 milliseconds) on repeated testing; a history of certain risk factors for a dangerous heart rhythm condition called Torsades de Pointes (such as heart failure, low potassium, or a family history of Long QT Syndrome); current use of medications that affect heart rhythm in this way; or a heart attack within the past 6 months, or heart failure requiring ongoing treatment for serious heart rhythm problems
• People with a known blood clotting disorder that increases bleeding risk, or a history of serious bleeding, including significant bleeding within or around the brain tumour
• People currently taking certain seizure medications known as enzyme-inducing anticonvulsants within two weeks of joining (note: people who have recently switched to a different type of seizure medication may still be eligible — confirm with trial site)
• People taking more than 8 mg per day of the steroid dexamethasone (or an equivalent dose of another steroid) at the time of joining
• People who have had radiation therapy within 26 weeks (approximately 6 months) before joining (including a specific type called gamma tiles)
• People who have had chemotherapy, immunotherapy, or any other experimental treatment within 4 weeks before joining, or certain specific chemotherapy drugs (carmustine/BCNU or lomustine/CCNU) within 6 weeks before joining
• People with a history of a lung condition called interstitial lung disease, including cases caused by a drug or by radiation treatment requiring steroid therapy, or any currently active interstitial lung disease
• People with a known allergy or serious sensitivity to WSD0628 or to medications with a similar structure or type
• People who have persistent nausea and vomiting that cannot be controlled, ongoing digestive conditions, an inability to swallow tablets or capsules, or who have had significant bowel surgery that may prevent the study drug from being properly absorbed
• People with uncontrolled high blood pressure
• People with a history of severe brain injury or stroke
• People who are currently taking part in another clinical trial that involves a treatment for their brain tumour

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