Ph 2 Elacestrant in ER Positive Uterine Sarcomas

NCT07467772 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 25-822
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the efficacy and safety of elacestrant, in participants with advanced estrogen receptor (ER)-positive uterine sarcomas. The name of the study drug involved in this research study is:

• Elacestrant (a type of selective estrogen receptor degrader)

Conditions

Uterine Sarcoma; Uterine Leiomyosarcoma; Endometrial Stromal Sarcoma; ESS; Perivascular Epithelioid Cell Tumors; Uterine Adenosarcoma; Uterine PEComa; Estrogen Receptor Positive Tumor; uLMS

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR)

  ORR is defined as proportion of participants achieving partial response (PR) or better on treatment per the Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1 (Eisenhauer et al. Eur J Ca 2009; section 11.0).

  Observed on treatment plus 30 days; Disease assessed on treatment every 8 (+/- 3 days) weeks for the first 14 cycles, then every 12 (+/- 3 days) weeks thereafter with longest follow-up estimated as 12 months.

• Treatment-Related Grade 3-4 Adverse Event (AE) Rate

  Percentage of participants who experience an AE of grade 3 or 4 with treatment attribution of possible, probable or definite per Common Toxicity Adverse Event Criteria (CTCAE) version 5 on treatment.

  Assessed continuously on treatment plus 30 days with longest follow-up estimated as 13 months.

Study Arms (1)

Elacestrant

EXPERIMENTAL

30 participants will be enrolled and will complete the following: * Baseline visit * Cycle 1 through End of Treatment (28 day cycles) --Days 1 - 28: predetermined dose of Elacestrant 1x daily * End of treatment visit * 30 day post-treatment follow up * Long term follow every 3 months

Drug: Elacestrant

Interventions

Elacestrant DRUG

Selective estrogen receptor degrader, tablet taken orally per protocol.

Also known as: RAD1901, Elacestrant Hydrochloride, Elacestrant Dihydrochloride, ASYM-122762, RAD1901 Dihydrochloride

Elacestrant

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must have histologically confirmed uterine sarcoma of one of the following subtypes: uterine leiomyosarcoma (uLMS), endometrial stromal sarcoma (ESS), uterine adenosarcoma, or uterine PEComa.
• Tumor must have moderate to strong immunohistochemical expression in ≥75% of tumor cells of estrogen receptor (ER) as assessed by institutional pathology review.
• Participants must have locally advanced or metastatic disease that is not amenable to surgery.
• Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.
• Age ≥18 years at the time of consent
• ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
• Participants must have adequate organ and marrow function as defined below:
• Hemoglobin ≥ 8.0 g/dL
• absolute neutrophil count ≥1,000/mcL
• platelets ≥100,000/mcL
• total bilirubin ≤1.5 × institutional upper limit of normal (ULN)
• AST(SGOT)/ALT(SGPT) ≤3.0 × institutional ULN (unless liver metastases are present in which case it must be ≤ 5 × ULN)
• glomerular filtration rate (GFR) ≥60 mL/min/1.73 m2
• Human immunodeficiency virus (HIV)-infected participants on effective non-CYP3A4 interacting (see Section 3.2.3) anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
• For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

You may not qualify if:

• Participants who are receiving any other investigational agents.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to elacestrant.
• Rapidly progressive, symptomatic, visceral spread of disease placing participant at risk of
• life- threatening complications in the short term.
• Participants with uncontrolled intercurrent illness, including but not limited to active infection, uncontrolled diabetes, cardiac disease, hypertension or conditions that in the opinion of the investigator would compromise participant safety or study participation
• Participants with psychiatric illness/social situations that would limit compliance with study requirements.
• Treatment with strong CYP3A inducers/inhibitors within 2 weeks before first study treatment administration or five elimination half-lives, whichever is longest and cannot be replaced. See Appendix B for a list of medications that are CYP3A inducers/inhibitors.
• Female participants who are pregnant or nursing.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Stemline Therapeutics, Inc.: collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Sarcoma, Endometrial Stromal; Perivascular Epithelioid Cell Neoplasms; Adenosarcoma of the uterus

Interventions

elacestrant; RAD1901

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Endometrial Stromal Tumors; Sarcoma; Neoplasms, Connective and Soft Tissue; Endometrial Neoplasms; Uterine Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases

Study Officials

• Suzanne George, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzanne George, MD

CONTACT

617-632-5204; suzanne_george@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: March 12, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Beffer office for Dana -Farber Innovations(BODFI) at innovations@dfci.harvard.edu

Locations

US (1)