A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Adults With Locally Advanced or Metastatic Solid Tumours Exposed to Immune Checkpoint Inhibitor Therapies

To join this study, you need to be at least 18 years old and have a solid tumour that has either grown locally or spread to other parts of your body, and your cancer must be measurable. You should generally be able to manage your daily activities and have recovered from most side effects of any previous cancer treatments. Certain long-lasting side effects, like mild nerve problems or hair loss, might still allow you to participate. You will also need to be able to understand and sign the consent form.

There are certain reasons why you might not be able to join. For example, if you have untreated or active brain tumours, or if you've had severe reactions to other similar cancer treatments in the past. People with certain severe heart conditions, a history of autoimmune diseases (where the body's immune system attacks itself), or certain brain-related health issues (like a stroke within the last year) would also not be eligible.

If you decide to take part, you'll first have a screening period that could last up to 28 days, which involves at least one visit to the study centre to check if the study is right for you. If you're eligible, you'll then start receiving the study drug, IPN01203. For the first two months, you'll have about 15 visits, and after that, you'll visit the centre about three times a month. These visits continue for as long as the treatment is helping you and you're not experiencing severe side effects.

During your time in the study, you'll have blood samples taken, provide urine samples, have physical check-ups, and other medical assessments. It's important to note you can continue some of your other medications, but the study team will need to know all the details. You'll stay in the study until the treatment is no longer helping, you experience side effects that are too difficult to manage, you decide to stop, or the study ends. There will also be a final check-up visit about a month after your last dose, and another safety check-up visit about three months after your last dose, or before you start any new cancer treatment.