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 aged 18 or older at the time of signing the consent form
• People who have been diagnosed through a tissue biopsy with a specific aggressive brain tumour (WHO Grade IV glioblastoma or astrocytoma) that has come back or continued to grow after radiation treatment, with or without chemotherapy
• People whose tumour has a specific genetic profile — a normal IDH gene and changes to the EGFR gene — confirmed by an approved laboratory test
• People who have had no more than two previous episodes of the tumour returning
• People who are able to have MRI scans, have recent MRI scans available for review, and whose tumour can be measured by MRI within 7 days of starting treatment
• People who have sufficiently recovered from side effects of previous treatments, with enough time passed since each prior treatment type (the required waiting periods vary depending on what treatment was received — confirm with trial site)
• People whose care team has determined that surgery is appropriate, and where the surgeon expects to be able to remove enough tumour tissue safely
• People for whom stored tumour tissue from their original diagnosis surgery is available
• People who are able to carry out basic self-care, with occasional help from others (a standard medical score of 60% or above on a function scale)
• People whose blood counts and organ function meet specific laboratory thresholds, including healthy enough levels of white blood cells, platelets, haemoglobin, kidney function, liver function, and blood clotting (confirm specific values with trial site)
• People whose heart function test (an echocardiogram) is within the normal range within 21 days of starting treatment
• People whose heart rhythm test (an ECG) shows a specific electrical interval measurement below a set threshold, taken within 2 weeks of starting treatment
• People who are able to give written consent to participate
• Women who could become pregnant must have a negative pregnancy test within 7 days before the first dose
• Women who could become pregnant and men must agree to use reliable contraception throughout the study and for a set period after the last dose (30 days for women; 4 months for men)
• People who have no other current cancer, except certain previously treated skin cancers or early-stage cancers that have been fully treated; people with a past cancer history must have been free of that cancer for more than three years
• People who are able to swallow tablets or capsules by mouth

Who may not be able to join:

• People who are currently taking part in another clinical trial involving an experimental treatment
• People who have had a significant allergic reaction to a drug that is chemically similar to the study drug ERAS-801
• People who have previously been treated with drugs that target the EGFR protein, as this may affect how the study drug works and how results are interpreted
• People currently taking certain anti-seizure medications known as enzyme-inducing anti-epileptic drugs (EIAEDs), unless they have stopped taking them at least 10 days before the first dose
• People who have significant problems with their blood, kidneys, or liver
• People who have evidence of significant bleeding in the brain
• People with serious heart or cardiovascular conditions, including a heart attack or unstable chest pain within the past 6 months, significant heart rhythm problems, a prolonged QTcF interval on ECG, uncontrolled high blood pressure, moderate-to-severe heart failure, a pacemaker, or a blood clot in the lungs within the past 30 days
• People with uncontrolled ongoing illness, active infection, or mental health or personal circumstances that the trial team believes would make it difficult to follow the study requirements
• Women who are pregnant, as the study drug's effects on an unborn baby are unknown; women who are breastfeeding are also excluded, as the potential risk to a nursing infant is unknown
• People who are currently taking, or expect to need, certain medications, foods, or herbal supplements known to significantly affect the way the body processes the study drug, within 10 days of joining the study (confirm specific substances with trial site)
• People with active liver or bile duct disease currently requiring antiviral treatment (some exceptions may apply — confirm with trial site)
• People with digestive system conditions that could affect how the study drug is absorbed, including difficulty swallowing pills, absorption disorders, ongoing nausea and vomiting, chronic gut disease, or a history of major bowel surgery with lasting effects
• People currently taking certain medications known as P-glycoprotein inhibitors (confirm specific drugs with trial site)
• People with known psychiatric conditions or substance use disorders that would interfere with their ability to follow the trial requirements

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