The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

This study is looking for people aged 18 or older with locally advanced or metastatic (spreading) solid cancers. Very occasionally, teenagers between 12 and 17 might be considered, but only after careful review by the study team. An important requirement is that your cancer must have a specific genetic change called a TP53 Y220C mutation.

You should have already received at least one course of cancer treatment, and your cancer should have progressed. Your general health and ability to perform daily activities should be good (known as an ECOG status of 0 or 1), and your organs, like your liver and kidneys, need to be working adequately. If you're joining the part of the study that uses rezatapopt by itself (monotherapy), they will also need to be able to measure your cancer on scans.

There are also some reasons why you might not be able to join. For example, if you've recently had other cancer treatments or radiotherapy, or if you have certain heart conditions, a history of stroke, or uncontrolled infections like Hepatitis B or C. People with certain brain tumors or uncontrolled spread to the brain, or issues that might affect how you absorb oral medication, would also likely be excluded. The study also cannot include individuals with another active cancer, unless it's a very specific type like treated cervical changes or certain skin cancers.

Taking part in this study would involve regular visits to the clinic to receive the study drug, rezatapopt, which is taken by mouth. If you are in the part of the study where rezatapopt is combined with pembrolizumab, pembrolizumab would be given intravenously (through a drip).

During your visits, you would have various assessments, including blood tests, physical examinations, and scans to monitor your cancer and assess how you are feeling. The frequency of visits and tests would be clearly explained by the study team. You would be closely monitored for any side effects or changes in your health.

The total duration of your participation would depend on how you respond to the treatment and the phase of the study you are in. You would continue to receive the study drug as long as it is helping and you are tolerating it well. Even after stopping the treatment, there would be follow-up visits or contacts to monitor your long-term health and the effects of the treatment.