An Open-label Dose Escalation/Expansion Trial to Evaluate the Safety and Anti-tumor Activity of TEV-56278 Alone or in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors

To join this study, you would generally need to have a confirmed diagnosis of certain types of solid tumours that are advanced or have spread. Doctors would usually consider you if your cancer has either not responded well to standard treatments, or if those treatments cause too many side effects, or if your doctor thinks other treatments aren't suitable for you.

You would also need to be expected to live for at least 12 weeks at the start of the study. If you are a woman who could become pregnant, you would need to agree to use effective contraception throughout the study and for a period afterwards. Men who are sexually active with women who could become pregnant would also need to use condoms and not donate sperm during the study and for a period afterwards.

There are also some reasons why you might not be able to join. For example, if you've recently had other cancer treatments like chemotherapy or radiotherapy, or certain types of surgery. You also wouldn't be able to join if you have certain conditions, such as a weakened immune system, active autoimmune diseases, known brain tumours or cancer in the fluid around your brain, serious infections, or serious heart or lung conditions. The study team will check all your health details to see if this study is right for you.

If you join this study, you'll receive the study medication, TEV-56278 (either on its own or with pembrolizumab), for up to 12 months. During this time, you will have regular visits to the clinic so the study team can monitor your health, check for any side effects, and see how the treatment is working. This will involve physical examinations, blood tests, and scans. After you finish the treatment, you'll have a follow-up period for up to another 12 months to continue checking on your health.

The total time you would be involved in the study, from starting treatment to the end of your follow-up, could be up to 25 months. If the treatment seems to be helping and is safe for you after the initial 12 months, you might be offered the chance to continue receiving the study medicine for up to another 12 months, if suitable.