Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors

To join this study, you would generally need to be an adult, aged 18 or older. You must have a confirmed diagnosis of certain advanced solid tumours. This includes specific kinds of head and neck cancer, pancreatic cancer, lung cancer, ovarian cancer (that has not responded to platinum treatment), or certain types of breast cancer (either hormone receptor-positive and HER2-negative that has progressed after a specific prior treatment, or triple-negative breast cancer).

Your cancer must be advanced, meaning that surgery or radiotherapy alone are not seen as a cure, and it should have come back or spread after you’ve had standard treatments. It’s also important that you are generally well enough to take part, meaning you can carry out most normal daily activities. Your body’s organs, such as your blood, liver, and kidneys, must be working well. Doctors would also need to be able to take a sample (biopsy) from your tumour or areas where it has spread, but not from bone.

There are also some reasons why you might not be able to join. For instance, if you have an active infection, severe nausea or vomiting, certain bowel problems, or have previously had another type of cancer, an organ transplant, or severe heart problems. If you have cancer that has spread to your brain causing symptoms, or if you’ve recently had other cancer treatments or certain medications that might interfere with the study drug, you would also not be eligible.

If you decide to take part in this study, you'll be given the study drug, GTAEXS617. Some participants might receive GTAEXS617, while others might receive what's called 'standard of care' (SoC), which means the usual treatment for your condition. The study will involve regular visits to the clinic for various assessments. These will include blood tests, checks of your general health, scans to monitor your cancer, and sometimes repeat tumour biopsies to see how the treatment is affecting the cancer cells. You will be closely monitored for any side effects or changes in your health.

The specific schedule of visits and tests will be explained in detail by the study team. Typically, you'd start with treatment and have regular follow-up appointments. The total length of your participation can vary depending on how you respond to the treatment and your overall health, but it will be made clear to you before you join. There will be initial assessment visits, regular treatment visits, and then follow-up after the treatment period has ended.