Study on Elacestrant Alone or with Abemaciclib for Endometrial Cancer

Inclusion Criteria

• Must be 18 years or older.
• Must be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Must have previously received platinum-based chemotherapy and a PD-1 inhibitor.
• Can have had no more than one prior line of chemotherapy for endometrial cancer.
• Can have had one prior line of hormone therapy for endometrial cancer.
• Must not have been treated with a CDK4/6 inhibitor before.
• Must have measurable cancer according to specific criteria.
• Must have advanced or recurrent endometrial cancer that cannot be cured with current treatments.
• Must have specific types of endometrial cancer, such as endometrioid adenocarcinoma or serous adenocarcinoma.
• Must have ER-positive cancer, confirmed by specific tests.
• Must not have certain genetic mutations.
• Must provide a tumor sample for additional testing if not already done.
• Female participants can be postmenopausal, premenopausal, or perimenopausal, with specific criteria for each.
• Must agree to use effective birth control during the study and for a period after.
• Must have completed any prior radiation therapy and recovered from its effects.
• Must have adequate blood and organ function as shown by specific lab tests.

Exclusion Criteria

• Cannot have participated in another clinical trial within the last 30 days.
• Cannot have severe organ dysfunction or rapidly progressing disease.
• Cannot have been treated with certain other cancer drugs before.
• Cannot have uncontrolled high cholesterol.
• Cannot have a history of certain lung diseases.
• Cannot have uncontrolled infections.
• Cannot be pregnant or nursing.
• Cannot have other cancers that might interfere with the study.
• Cannot have had major surgery recently.
• Cannot have conditions that prevent taking oral medication.
• Cannot have known allergies to the study drugs.
• Cannot have severe medical or psychiatric conditions that would interfere with the study.
• Cannot have certain electrolyte imbalances.
• Cannot have untreated or active brain metastases.
• Cannot be taking certain medications that interfere with the study drugs.
• Cannot have any other conditions that might make the study unsafe or affect the results.