Actively Recruiting
Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
Led by Ellipses Pharma · Updated on 2026-03-20
95
Participants Needed
14
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women 18 years or older at the time of informed consent
- Histologically confirmed diagnosis of metastatic or locally advanced breast adenocarcinoma
- Availability of archival tumor tissue or willingness to provide a fresh biopsy
- Biopsy-proven androgen receptor positive (AR+) and estrogen receptor positive (ER+) breast cancer
- AR+ defined as 6% or greater nuclei staining by immunohistochemistry depending on study module
- HER2-negative breast cancer confirmed by fluorescence in situ hybridisation or immunohistochemistry
- Postmenopausal status defined by age, amenorrhea, hormone levels, or prior bilateral oophorectomy
- For Module B: progression on two or fewer prior lines of endocrine therapy including prior CDK4/6 inhibitor
You will not qualify if you...
- Recent anti-cancer or investigational drug treatment within specified time frames before study drug
- Use of testosterone, methyltestosterone, oxandrolone, oxymetholone, danazol, fluoxymesterone, or similar androgenic agents
- Radiation therapy within 14 days prior to study drug or planned radiation during study without approval
- Unresolved or unstable serious toxic side effects from prior treatments
- Prolonged QT interval or history of certain heart conditions
- Heart rhythm abnormalities except rate-controlled atrial fibrillation
- Use of medications that prolong QT interval and cannot be discontinued
- Congestive heart failure Grades II-IV
- Recent myocardial infarction or unstable angina within 6 months
- Use of strong CYP3A4 inhibitors or inducers before study drug
- Prior treatment with selected combination agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Yale School of Medicine
New Haven, Connecticut, United States, 06520
Completed
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
4
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
5
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
6
Texas Oncology Baylor University Medical Center
Dallas, Texas, United States, 75246
Actively Recruiting
7
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
8
Hospital 12 de Octubre
Usera, Madrid, Spain, 28041
Actively Recruiting
9
Hospital Universitari Vall d'Hebron (VHIO)
Barcelona, Spain, 08035
Actively Recruiting
10
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
11
NEXT Oncology Hospital Quironsalud
Madrid, Spain, 28223
Actively Recruiting
12
Sarah Cannon Research Institute UK
London, London, United Kingdom, W1G 6AD
Actively Recruiting
13
The Christie NHS Foundation Trust
Manchester, Wilmslow Rd, United Kingdom, M20 4BX
Actively Recruiting
14
The Clatterbridge Cancer Centre
Liverpool, United Kingdom, CH63 4JY
Actively Recruiting
Research Team
C
Clinical Trials Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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