A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

To join this study, you would generally need to have advanced or spreading solid cancer that includes specific types like ovarian, pancreatic, or bowel cancer. You must be at least 18 years old. Importantly, if your cancer has a specific genetic change (like a BRCA mutation) and there’s an approved medicine called a PARP inhibitor for it, you would typically need to have tried that treatment first, unless there's a medical reason why you couldn't.

Also, you would need to be reasonably well and able to carry out most of your daily activities. Your body systems, like your blood, kidneys, and liver, need to be working properly. If you've had cancer treatments recently, like chemotherapy or radiation, you’d need to have finished those treatments a certain amount of time beforehand and recovered from any strong side effects. The doctors would also need to be able to measure your cancer to see if the treatment is working.

Crucially, you should be willing and able to come to all the study appointments and follow the study instructions carefully. If you are a woman who could become pregnant, or a man with a partner who could become pregnant, you would need to use effective birth control during and for some time after the study.

Taking part in this study would involve regular visits to the clinic. You would receive the study drug, ART0380, either on its own or together with gemcitabine or irinotecan, depending on which part of the study you are in. These treatments would be given according to a set schedule. Doctors will closely monitor your health throughout with regular check-ups, blood tests, and scans to see how you are responding to the treatment and to check for any side effects.

Before you start, and at different times during the study, you would have medical exams, blood and urine tests, and imaging scans (like CT scans) to assess your cancer and general health. You would also be asked to provide a sample of your tumour tissue (either from a past biopsy or a new one) for testing. You will need to use effective contraception if you are able to have children. The total length of your participation would depend on how your cancer responds to the treatment and what the study doctors decide is best for you, but generally you would be expected to commit to the study for at least 12 weeks.