First-in-Human Study of ICT01 in Patients With Advanced Cancer

This study is for adults, aged 18 and over, who have advanced cancer that has come back or spread, and hasn't responded to standard treatments. You'll need to have a confirmed diagnosis of certain types of solid tumours (like bladder, breast, colon, gastric, melanoma, ovarian, prostate, or pancreatic), or blood cancers (like acute myeloid leukaemia, acute lymphocytic leukaemia, or certain lymphomas). You also need to be generally well enough to take part, as judged by your doctor, with a life expectancy of more than three months.

There are some reasons why you might not be able to join the study. For example, if you've recently had other anti-cancer treatments or investigational drugs within the last month, or if you're taking high doses of steroid medication. You also can't have certain rapid-growing diseases or a type of cancer that originates from a specific kind of immune cell (Vγ9Vδ2 T cells). The study team will review your full medical history to confirm if you meet all the requirements.

If you decide to take part, you'll first have some screening tests to check if you're suitable. Once enrolled, you'll receive the study drug, ICT01, which will be given directly into your vein (intravenously). Some participants will receive ICT01 by itself, while others will receive it alongside pembrolizumab (Keytruda). You'll have regular hospital visits for blood tests, scans, and check-ups to monitor your health, how the drug is affecting you, and how your cancer is responding. The number and frequency of these visits will vary depending on which part of the study you are in. You'll remain in the study for as long as the treatment is beneficial and safe, or until you choose to withdraw. The full duration of your participation, including follow-up after treatment, will be explained in detail.