A Phase 1/2 Study of NUV-868 Alone and With Olaparib or Enzalutamide in People With Advanced Prostate Cancer

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Full Title

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

Purpose

Prostate cancers initially need the male hormone testosterone to grow. Hormone therapies that lower testosterone are among the best treatments for prostate cancers that spread to other organs (metastasized). The benefits of hormone treatments do not last, however. Over time, many prostate cancers continue to grow even with hormonal therapies; these are called “castration-resistant prostate cancers” (CRPC). 

Researchers want to find the best dose of NUV-868 to give with other treatments in people with metastatic CRPC. NUV-868 blocks the action of a protein called BRD4 that tells cancer cells to grow. If you join this study, you will receive NUV-868 with one of two other drugs: either olaparib or enzalutamide. All three medications are taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have metastatic CRPC.
  • Have recovered from the serious side effects of prior treatments before getting the study therapy.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information and to see if you can join this study, please call Dr. Wassim Abida’s office at 646-422-4633.

Protocol

23-095

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05252390