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Looking for participantsPhase1/Phase2

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

Sponsor: Ellipses Pharma

NCT ID: NCT05573126

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
EP0062 (drug), Elacestrant (drug), Everolimus (drug), Abemaciclib (drug)
How long the study runs
Study runs about 61 months (dates as stated)
About the drug or intervention
EP0062 — drug: EP0062 is an orally administered investigational selective androgen receptor modulator (SARM) · Elacestrant — drug: Oral SERD · Everolimus — drug: mTOR Inhibitor · Abemaciclib — drug: CDK4/6 inhibitor · Fulvestrant — drug: Oral SERD · Exemestane — drug: aromatase inhibitor
Patient visit burden
Not specified by the sponsor

In plain English

This early-stage (Phase 1/2) study is testing a new drug called EP0062, on its own and in combination with other treatments, in women with advanced or spread (metastatic) breast cancer that is hormone receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-negative). It is funded by Ellipses Pharma.

Who can take part

  • Women aged 18 or over
  • Breast cancer that has spread or is locally advanced, and no standard treatment is available, suitable, or wanted by the patient
  • A stored tumour sample is available, or the patient can have a new biopsy if not
  • Cancer tests positive for androgen receptors (AR+) and oestrogen receptors (ER+), with minimum levels of AR staining depending on the study part
  • Cancer tests negative for HER2
  • Patients must be past the menopause (rules based on age, periods stopping, hormone blood tests, or having had both ovaries removed)
  • For some parts of the study, patients must have already been treated with hormone therapy and/or a CDK4/6 inhibitor drug that stopped working

Who may not be able to

  • Recent cancer treatment before the study starts (chemotherapy, tamoxifen, aromatase inhibitors, fulvestrant, or other experimental drugs within set time limits)
  • Currently taking testosterone or similar hormones, or anti-androgen medicines
  • Radiotherapy within 14 days before starting, or planned during the study (short palliative courses may be allowed)
  • Ongoing serious side effects from earlier treatment, other than tiredness, hair loss, or certain nerve problems
  • Certain heart conditions, including a long QT interval on a heart trace, some heart rhythm problems, heart failure, or a recent heart attack or unstable angina
  • Taking certain medicines that affect the QT interval or that strongly affect how the body processes the study drug, if they cannot be stopped or swapped
  • Previous treatment with the selected combination drug

What taking part involves

  • • Taking the study drug EP0062, either on its own or in combination with another treatment
  • • Having tests such as heart traces (ECG) and tumour biopsies
  • • Attending study visits at a hospital or clinic for checks and treatment

Time commitment: Not stated — ask the trial team about how long the study lasts, how many visits are needed, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
Female
Number of participants
95
Started
2023-01-11
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for hormone receptor-positive breast cancer
  • • Phase1/Phase2 - 95 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with hormone receptor-positive breast cancer
  • • Female only

Where?

  • • London - Sarah Cannon Research Institute UK
  • • Manchester - The Christie NHS Foundation Trust
  • • Liverpool - The Clatterbridge Cancer Centre

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

More detail

EP0062 is being investigated in this modular, interventional, open label, Phase 1/2 dose finding, optimisation and expansion study to determine the optimal dose of EP0062 given as monotherapy and for evaluation in combination with standard-of-care therapies in patients with Relapsed Locally Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer. Module A (phase 1 dose finding) has completed and an optimal dose has been selected for module B (phase 2 expansion).

Hormone Receptor-positive Breast CancerHormone Receptor Positive HER-2 Negative Breast CancerMetastatic Breast Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Female only

Biomarkers mentioned

ERHER2defined as negative

What the study is looking for

  • ✓Women 18 years or older at the time of agreement to take part
  • ✓Biopsy-proven AR+ and ER+ breast cancer
  • ✓For Module A, AR+ breast cancer is defined as ≥ 10% AR nuclei staining by central immunohistochemistry (IHC) using...
  • ✓For Modules B and C, AR+ breast cancer is defined as ≥ 30% AR nuclei staining by central IHC using the Ventana assay
  • ✓Postmenopausal, as defined by at least one of the following:

Who cannot take part

  • ✗Patients with any of the following will not be included in the study:
  • ✗Prior anti-cancer or investigational drug treatment within the following time windows:
  • ✗Any drug treatment within 21 days prior to the first dose of the study treatment
  • ✗Any non-drug treatment investigational anti-cancer drug \< 5 half-lives (28 days for biologics) or \< 14 days for...
  • ✗Tamoxifen and aromatase inhibitors within 14 days prior to the first dose of the study treatment
See the full criteria
Inclusion Criteria: 1. Women 18 years or older at the time of informed consent 2. Histologically proven diagnosis of breast cancer with evidence of metastatic or locally advanced breast adenocarcinoma as defined by the American Joint Committee on Cancer/Union for International Cancer Control/Tumour Node Metastases (AJCC/UICC TNM) staging classification (8th Ed, 2017) and where no conventional therapy is available or considered appropriate by the Investigator or is declined by the patient 3. Availability of archival tumour sample (formalin-fixed, paraffin-embedded block(s) or slides from a primary tumour or biopsy of a metastatic tumour lesion or lesions); in the absence of an archival tumour sample, or if only archival bone tissue is available, a fresh biopsy will need to be collected 4. Biopsy-proven AR+ and ER+ breast cancer * For Module A, AR+ breast cancer is defined as ≥ 10% AR nuclei staining by central immunohistochemistry (IHC) using the Ventana assay * For Modules B and C, AR+ breast cancer is defined as ≥ 30% AR nuclei staining by central IHC using the Ventana assay 5. HER2-negative breast cancer, defined as negative by fluorescence in situ hybridisation (FISH) or IHC score of 0 or 1+. If IHC is equivocal at 2+, a negative FISH test (HER2/Amplification of the centromeric region of chromosome 17)CEP17 ratio of \<2.0) is required 6. Postmenopausal, as defined by at least one of the following: 1. Age over 60 years 2. Amenorrhea \> 12 months at the time of informed consent and an intact uterus, with follicle-stimulating hormone (FSH) and oestradiol in the postmenopausal ranges (as per local practice) 3. FSH and oestradiol in the postmenopausal ranges (as per local practice) in women aged \<55 years who have undergone hysterectomy 4. Prior bilateral oophorectomy 7. Module B arm 1: patients who have progressed on ≤ 2 prior lines of endocrine therapy, including a prior CDK4/6 inhibitor. 8. Module B arm 2: patients who have progressed on ≤ 2 prior lines of endocrine therapy in advanced/metastatic setting, including prior CDK4/6 inhibitor 9. Module B arm 3: patients who have progressed on treatment with a prior CDK4/6 inhibitor plus an aromatase inhibitor as initial therapy or recurrence on/after treatment with a CDK4/6 inhibitor plus endocrine therapy in the adjuvant setting. Exclusion Criteria: Patients with any of the following will not be included in the study: 1. Prior anti-cancer or investigational drug treatment within the following time windows: * Any chemotherapy within 21 days prior to the first dose of study drug * Any non-chemotherapy investigational anti-cancer drug \< 5 half-lives (28 days for biologics) or \< 14 days for small-molecule therapeutics or if half-life is not known * Tamoxifen and aromatase inhibitors within 14 days prior to the first dose of study drug * Fulvestrant or other investigational Selective Estrogen Receptor Degraders (SERDs) within 21 days prior to first dose of study drug 2. Currently taking testosterone, methyltestosterone, oxandrolone, oxymetholone, danazol, fluoxymesterone, testosterone-like agents (e.g., dehydroepiandrosterone, androstenedione, and other androgenic compounds, including herbals), or antiandrogens 3. Radiation therapy within 14 days prior to the first dose of study drug and scheduled to have radiation therapy during participation in this study. Short courses of palliative radiation therapy during the study might be allowed following discussion with and approval by the Medical Monitor. Palliative radiotherapy within 6 weeks prior to first dose of study drug is permitted 4. Unresolved or unstable serious toxic side effects of prior chemotherapy or radiotherapy, i.e., ≥ Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except fatigue, alopecia, and Grade 2 chemotherapy-induced neuropathy 5. Confirmed Corrected QT Interval by Fridericia (QTcF) \> 470 ms on screening ECG, or history of torsades de pointes (TdP), or history of congenital long QT syndrome, or immediate family history of long QT syndrome, unexplained sudden death at a young age, or sudden cardiac death 6. Any other clinically important abnormalities in rhythm, conduction, or morphology on resting ECG (e.g., complete left bundle branch block, third-degree heart block); rate-controlled atrial fibrillation is permitted 7. Concomitant medications that prolong the corrected QT interval and/or increase the risk for TdP that cannot be discontinued or substituted with another drug within 5 half-lives or 14 days before the first dose of study drug, whichever is longer 8. Congestive heart failure Grades II-IV according to the New York Heart Association at the time of screening 9. Myocardial infarction or unstable angina within the previous 6 months 10. Patients receiving medications that are known to be strong inhibitors or inducers of CYP3A4 within 5 half-lives or 14 days, whichever is longer, before the first dose of study drug 11. Prior treatment with selected combination agent

Where Is This Study? (3 UK sites)

Sarah Cannon Research Institute UK

London W1G 6AD, United Kingdom

Recruiting

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

The Clatterbridge Cancer Centre

Liverpool CH63 4JY, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Maria Maguire

maria.maguire2@nhs.net0151 556 5321

How to Get in Touch

Clinical Trials Team

Sponsor contact

CONTACT

+44 (0)20 3743 0992 Enquiries@ellipses.life
Data sourced from ClinicalTrials.gov · Last verified: 2026-06