A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer

What does the study involve? This clinical trial is split into two phases. Phase I (Module A) is the 'dose escalation' phase. This is where small groups of participants receive UCB4594 at a certain dose level starting with a low dose level. After reviewing the results obtained at each dose level, it will be decided whether or how much to increase the dose for the next group of participants. This part of the study aims to find the best dose to give that does not cause too many side effects. Phase II is the 'dose expansion' phase. This starts when the dose escalation phase has worked out the best dose of UCB4594 to give. In this part of the trial UCB4594 will be given alone (Module B) or in combination with other anti-cancer drugs (Module C). This will allow us to find out more about how the drug is working and whether UCB4594 affects cancer. Details for Module C of the dose expansion phase will be added when the types of cancer and anti-cancer drugs are defined. What are the possible benefits and risks of participating? UCB4594 is a new drug that has never been given to humans before. Possible risks and benefits are based on laboratory tests and experience with similar drugs but there is not yet any information about the effects of UCB4594 in humans. Participants in the trial will be monitored closely to find out the effects of UCB4594.