A Phase 2 Study of Elacestrant Alone or With Abemaciclib in People With Endometrial Cancer

Full Title

A Phase II Study of Elacestrant in Combination with Abemaciclib or Elacestrant Alone In p53 Wild Type, Estrogen Receptor-positive Advanced or RecurrenT Endometrial Cancer (ELITE)

Purpose

Researchers want to see if elacestrant alone or with abemaciclib works well against endometrial cancer. The people in this study have endometrial cancer that has spread or come back. Their cancers have a protein called the estrogen receptor (ER) and they have a normal version of the p53 gene. This gene stops cancer from growing.

Elacestrant blocks and breaks down ER, which plays a role in the growth and development of certain cancers. Abemaciclib blocks proteins called CDKs, which control cell division. By blocking CDKs, abemaciclib may help slow or stop the growth of your cancer.

If you take part in this study, you will take elacestrant alone or with abemaciclib. Both drugs are taken orally (by mouth).

Who Can Join

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

  • Have ER-positive endometrial cancer that has spread or come back.
  • Have normal p53.
  • Have cancer that persists despite prior treatment with immunotherapy and platinum-based 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 or to see if you can join this study, please call Dr. Angela Green’s office at 646-888-6792.

Protocol

25-164

Phase

Phase II (phase 2)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT07209449