A phase II trial of CY-101 in participants with adrenocortical cancer

This study is looking for around 41 people aged 16 or older who have adrenocortical cancer (ACC) that has spread and cannot be removed by surgery. You would need to have already received one or two other treatments for this advanced cancer, and it's important that your cancer has recently shown signs of growing. You must also have a life expectancy of at least 12 weeks and be generally well enough to take part.

To join, you need to have at least one cancerous area that can be measured to see if the treatment is working. This area should also be suitable for direct injection. It's also important to have some tissue available from a past biopsy or surgery for further testing. You won't be able to join if you've had certain other treatments like chemotherapy or radiotherapy in the last 28 days, although continued treatment with a drug called mitotane may be allowed under specific conditions.

If you decide to take part, the trial will happen in two main stages. In the first stage, a smaller number of participants will receive different doses of CY-101 to help researchers find the best and safest dose. In the second stage, more people will receive this chosen dose to gather more information about how well it works and its effects.

CY-101 will be given directly into your cancer spots (known as lesions) using a needle. This is called an intratumoural injection. These injections will often be guided by scans like ultrasound or CT scans to make sure the drug goes into the right place. You will need to make regular visits to the hospital for these injections, along with tests like blood tests, scans (CT and PET scans), and possibly further biopsies. These close check-ups are to monitor your health, see how the treatment is working, and identify any side effects. The study is planned to run from March 2026 to July 2032.