Phase 1 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:

• Adults aged 19 years or older at the time of agreeing to participate
• People who have been diagnosed with glioblastoma (GBM) according to World Health Organization criteria
• People whose GBM has come back or gotten worse after receiving the standard initial treatment
• People who have one or more tumour areas that can be measured or assessed using standard brain tumour response guidelines
• People who are generally able to carry out daily activities with no or minimal limitations, based on a standard medical rating scale (ECOG score of 0 or 1)
• People taking steroid medications whose dose has been stable and has not needed to be increased for at least 2 weeks before starting the trial treatment
• Women who could potentially become pregnant must agree to use acceptable contraception until 6 months after finishing the trial treatment, and must have evidence confirming they are not currently pregnant
• Men who have not had a vasectomy must agree to use acceptable contraception themselves, and ensure their partner does also, until 3 months after finishing the trial treatment
• People who have been fully informed about the trial, choose to take part voluntarily, and provide written consent

Who may not be able to join:

• People who have already received chemotherapy specifically for recurrent (returned) glioblastoma after their initial standard treatment
• People who have not yet recovered from side effects of previous cancer treatments
• People who have had major gastrointestinal surgery that could make swallowing or absorbing oral medication difficult or impossible
• People who had major surgery requiring general anaesthesia within 4 weeks before the screening visit
• People with a history of another type of cancer, except for certain early-stage or treated skin, cervical, thyroid, or stomach cancers (confirm with trial site)
• People with certain inherited conditions affecting how the body processes specific substances, such as galactose intolerance
• People with known allergies to any ingredient in the trial drug BEY1107 or to temozolomide (a standard brain cancer drug)
• People with known allergies to a drug called dacarbazine
• People with cardiovascular (heart or blood vessel) disease identified at screening
• People with active hepatitis B, hepatitis C, or HIV
• People with a current serious or acute infection
• People currently taking rifampin, phenytoin, or antifungal medications from the azole class
• People who have taken part in another clinical trial and received an investigational drug within 4 weeks before screening
• People with inadequate bone marrow, kidney, or liver function
• Women who are pregnant, breastfeeding, or who have a positive pregnancy test at screening
• People whose treating doctor estimates they have less than 12 weeks life expectancy
• People who the trial investigator determines are not suitable for any other reason

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