RecruitingPhase 1Phase 2NCT05573126

Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer

A Modular, Open-Label, Multi-Centre Phase 1/2 Dose-Finding, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0062 as Monotherapy and in Combination in Patients With Relapsed Locally Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer


Sponsor

Ellipses Pharma

Enrollment

95 participants

Start Date

Jan 11, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this study is to identify the optimal dose for EP0062 as monotherapy and in combination with standard-of-care therapies to assess its Safety, Tolerability, Pharmacokinetics, and Efficacy in Patients with Relapsed Locally Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called vosilasarm (EP0062) — alone and in combination with other treatments — for women with advanced or metastatic breast cancer that is hormone receptor-positive (ER+), HER2-negative, and also expresses a protein called androgen receptor (AR+). The goal is to find a safe dose and early signs of effectiveness. **You may be eligible if...** - You are a woman 18 or older - You have been diagnosed with metastatic or locally advanced breast cancer that is ER+, AR+, and HER2-negative - Standard treatments are no longer available, appropriate, or you have declined them - You can provide a tumor tissue sample (from surgery or biopsy) **You may NOT be eligible if...** - You have active brain metastases - Your overall health or organ function does not meet study requirements - You have had certain prior treatments that exclude you from the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEP0062

EP0062 is an orally administered investigational selective androgen receptor modulator (SARM)

DRUGElacestrant

Oral SERD

DRUGEverolimus

mTOR Inhibitor

DRUGAbemaciclib

CDK4/6 inhibitor

DRUGFulvestrant

Oral SERD

DRUGExemestane

aromatase inhibitor


Locations(14)

Yale School of Medicine

New Haven, Connecticut, United States

Moffitt Cancer Center

Tampa, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Texas Oncology Baylor University Medical Center

Dallas, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Hospital 12 de Octubre

Usera, Madrid, Spain

Hospital Universitari Vall d'Hebron (VHIO)

Barcelona, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

NEXT Oncology Hospital Quironsalud

Madrid, Spain

Sarah Cannon Research Institute UK

London, London, United Kingdom

The Christie NHS Foundation Trust

Manchester, Wilmslow Rd, United Kingdom

The Clatterbridge Cancer Centre

Liverpool, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05573126


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