Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors

To be considered for this study, you need to be at least 18 years old. You must have oesophageal cancer (including certain types like adenocarcinoma or squamous cell cancer, or cancer at the junction of the food pipe and stomach) or pancreatic cancer that is advanced and cannot be removed by surgery, and you must not have had any previous drug treatments for this advanced cancer.

Your cancer also needs to be measurable, meaning doctors can see and track its size. You should be fairly well and active in your daily life (doctors use a score called ECOG 0 or 1 for this) and your body's organs, such as your liver and kidneys, need to be working properly. You also need to be able to take medicines by mouth.

There are some reasons why you wouldn't be able to join. For example, if your cancer could be cured by surgery or radiotherapy, or if you have certain types of cancer that can be treated with other specific drugs (like HER-2 positive cancer). Also, if you’ve had similar types of drugs to futibatinib or pembrolizumab before, or have certain other medical conditions like another active cancer, some heart, eye, or immune system problems, or certain infections like HIV or hepatitis, you wouldn't be able to take part. Women who are pregnant or breastfeeding also cannot join.

If you join this study, you will receive the new drug futibatinib by mouth, along with pembrolizumab (which is given through a drip) and standard chemotherapy (also given through a drip). The exact chemotherapy drugs you receive will depend on whether you have oesophageal or pancreatic cancer. For example, if you have oesophageal cancer, you might get a combination like Cisplatin and 5-FU, or Oxaliplatin, Leucovorin, and 5-FU. If you have pancreatic cancer, you'd likely get a combination including Oxaliplatin, Leucovorin, 5-FU, and Irinotecan.

Initially, you'll receive all these treatments together (this is called the 'induction phase'). After a period, if the treatment is working well, you will continue with futibatinib and pembrolizumab without the chemotherapy (this is called the 'consolidation phase'). You will have regular hospital visits for treatments, blood tests, scans, and check-ups to monitor your health, how the treatment is working, and any side effects. The exact number and frequency of visits will be explained by the study team. The total duration of your participation will vary depending on how you respond to the treatment.