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

NCT07209449 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 25-164
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 7

Brief Summary

The researchers are doing this study to find out whether elacestrant is an effective and safe treatment alone or in combination with abemaciclib for people with advanced or recurrent ER+ endometrial cancer.

Conditions

Endometrial Cancer

Keywords

Elacestrant; Abemaciclib; p53 Wild Type; Estrogen Receptor-positive; Advanced or Recurrent; 25-164

Outcome Measures

Primary Outcomes (1)

• objective response rate

  according to RECIST 1.1 criteria. Defined as the percentage of patients with complete response (CR) + partial response (PR)\] after initiating therapy.

  1 year

Study Arms (2)

Abemaciclib plus Elacestrant

EXPERIMENTAL

Patients receiving both drugs should take elacestrant orally once daily with abemaciclib orally in the morning and abemaciclib orally only in the evening at the same time every day.

Drug: Abemaciclib; Drug: Elacestrant

Elacestrant alone

EXPERIMENTAL

Patients receiving elacestrant only should take orally once daily in the morning.

Drug: Elacestrant

Interventions

Abemaciclib DRUG

orally only in the evening

Abemaciclib plus Elacestrant

Elacestrant DRUG

orally once daily in the morning

Abemaciclib plus Elacestrant; Elacestrant alone

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Endometrial Cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years at the time of informed consent.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Patients must have received previous platinum-based chemotherapy and treatment with a PD-1 inhibitor, together or separately, prior to enrolling on this trial.
• Patients may have received no more than 1 prior line of chemotherapy for management of endometrial carcinoma. This includes platinum-based chemotherapy alone or combined with a PD-1 inhibitor, small molecule agents, and chemotherapy in combination with radiation therapy. A washout period of 14 days is required for chemotherapy °Adjuvant chemotherapy completed ≥ 12 months prior will not be counted toward prior therapy
• Patients may have received ≤ one prior line of endocrine therapy for management of endometrial carcinoma.
• No prior treatment with a CDK4/6 inhibitor
• Measurable disease per RECIST v 1.1 criteria
• °Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented, or a biopsy is obtained to confirm persistence of tumor ≥ 90 days following completion of radiation therapy.
• Advanced or recurrent endometrial carcinoma that is refractory to curative therapy.
• Patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, de-differentiated, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma.
• Patient must have ER-positive tumor status either from the most recent sample of advanced/recurrent disease or from an archival tissue.
• °Documentation of ER-positive tumor with ≥ 1% staining by IHC as defined in the 2010 or 2020 American Society for Clinical Oncology recommendations for ER testing (Hammond 2010, Allison 2020)
• p53 wt by IHC or TP53 wt by next generation sequencing platform either from the most recent sample of advanced/recurrent disease or from an archival tissue.
• No known dMMR or POLE mutation
• If MSK IMPACT mutational profiling or mutational profiling performed in a CLIA laboratory is not already performed, must have tissue available for MSK IMPACT molecular profiling to be performed clinically

You may not qualify if:

• Patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to randomization, or is currently enrolled in any other type of medical research not scientifically or medically compatible with this study.
• Patient who is experiencing a visceral crisis, lymphangitic disease spread, leptomeningeal carcinomatosis. Visceral crisis is not the mere presence of visceral metastases but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of disease.
• Patients who have received prior treatment with elacestrant or other investigational oral SERD, everolimus, temsirolimus, ridaforolimus or another mTOR inhibitor, or any CDK4 and CDK6 inhibitor
• Patients with hyperlipidemia that is not adequately controlled.
• Patients with history of interstitial lung disease (ILD)/pneumonitis or evidence of ILD/pneumonitis on baseline imaging.
• Uncontrolled significant active infections. °HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
• control). Patients with a history of treated CNS metastases are eligible, provided that they meet all of the following criteriaFor patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
• Females who are pregnant or nursing. If with childbearing potential, should have a negative urine pregnancy test at the time of screening.
• Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
• Major surgery within 4 weeks of randomization
• Inability to take oral medication, or history of malabsorption syndrome or any other uncontrolled gastrointestinal condition.
• Known intolerance to either study drug or any of the excipients.
• Any severe medical or psychiatric condition that in the opinion of the investigator(s) would preclude the patient's participation in a clinical study.
• Uncontrolled hypomagnesemia or hypokalemia, defined as values below the lower limit of normal despite optimal electrolyte supplementation or management

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Endometrial Neoplasms; Recurrence

Interventions

abemaciclib; elacestrant

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sminu Bose, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sminu Bose, MD

CONTACT

646-888-5427; boses1@mskcc.org

Vicky Makker, MD

CONTACT

646-888-4224

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a phase 2 single institution parallel two-arm randomized trial

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 7, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (7)