An Open-label, Dose Escalation, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-676 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced or Metastatic Solid Tumors

This clinical trial is designed to investigate a new medication called TAK-676 for adults who have advanced or metastatic solid tumours. 'Advanced' means the cancer is no longer confined to its original site, and 'metastatic' means it has spread to other parts of the body. The main goal of this study is to carefully check if TAK-676 is safe to use and how well people tolerate it. This is really important, especially since it's a new drug being given to people for the first time.

The study will look at TAK-676 in two main ways: first, as a standalone treatment, and then in combination with another established cancer drug called Pembrolizumab (you might know it as Keytruda). By doing this, researchers hope to understand if combining these drugs could be more effective. They will also be studying how the drug moves through the body (pharmacokinetics) and what effects it has on the cancer (pharmacodynamics). This helps them understand the best way to give the medicine and if it's working as expected.

This trial includes different stages (Phase 1 and Phase 2). In the early stages (Phase 1), a small group of patients will receive increasing doses of TAK-676 to find the highest dose that can be given safely without causing too many severe side effects. Once a safe dose is established, the study will expand (Phase 2) to include more patients to get a better idea of how well the drug works against the cancer and to continue monitoring safety. Other cancer treatments like Cisplatin and Fluorouracil are also part of wider treatment plans, depending on the specific type of solid tumour being treated.