Phase 1/2 Safety and Efficacy Study of NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors

NUV-868 is a small molecule bromodomain 2 (BD2)-selective bromodomain and extra-terminal domain (BET) inhibitor. The BET family of proteins have critical biological functions and are found to be altered in many human cancers.

In this study, the sponsor and investigators want to learn:
• How much of the study drug can be given alone and in combination with Olaparib or Enzalutamide with an acceptable level of side effects
• The effects of the study drug alone and in combination with Olaparib or Enzalutamide (good and bad)
• How much of the study drug is absorbed into the blood and how fast it is removed
• How the study drug is acting on your body
• If research tests can be used in the future to predict who will benefit from the study drug when given alone or in combination with Olaparib or Enzalutamide

This is a dose escalation/expansion study of the study drug alone or in combination with Olaparib or Enzalutamide. In the dose escalation part of the study, the amount of the study drug given will be increased in each group of research participants, to find the most appropriate dose for further study. In the dose expansion part of the study, a larger number of people receive the study drug dose determined to be appropriate in the dose escalation part of the study.

The study treatment will be given in cycles. Each cycle is 28 days. You will receive the study drug as capsules/tablets by mouth, once daily.

If you are enrolled in Regimen 1, you will be taking the study drug with Olaparib. Olaparib will be taken as capsules/tablets by mouth two times a day and taken about 12 hours apart.