RecruitingPhase 1 / Phase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests EP0062 alone and with standard treatments to find the best dose and learn how safe it is and how well it works. It is for women past menopause whose breast cancer has come back and has grown nearby or spread to other parts of the body. The cancer must be AR-positive and ER-positive, with hormone-binding proteins, and HER2-negative.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 18 or older.
  • Breast cancer confirmed by a tissue test that has grown nearby or spread. No usual treatment is available or suitable, or the patient has declined it.
  • A stored tumor sample is available. A new tissue sample is needed if there is no stored sample or only a stored bone sample.
  • Cancer tests positive for androgen receptors (AR) and estrogen receptors (ER). The AR test must be positive in at least 10% of cells for Module A or 30% for Modules B and C.
  • Cancer tests negative for HER2, a protein that helps cancer cells grow. An unclear result needs a second test to confirm it is negative.
  • Past menopause under the study’s rules, based on age, periods and hormone tests, or surgery to remove both ovaries.
  • Module B, arms 1 and 2: Cancer worsened after no more than two rounds of hormone treatment, including a CDK4/6 inhibitor, a drug that blocks cancer growth. Arm 2 requires those treatments to have been for advanced or spreading cancer.
  • Module B, arm 3: Cancer worsened on a CDK4/6 inhibitor plus an aromatase inhibitor, which lowers estrogen, as the first treatment; or cancer returned during or after a CDK4/6 inhibitor plus hormone treatment given to prevent its return.

Who can't join

  • Recent cancer treatment: chemotherapy within 21 days; tamoxifen or aromatase inhibitors within 14 days; or fulvestrant or similar study drugs within 21 days. Other study cancer drugs have waiting periods based on the drug type and how long it stays in the body.
  • Currently taking testosterone, testosterone-like drugs or herbs, or drugs that block these hormones.
  • Radiation within 14 days before study treatment and planned radiation during the study. Some radiation to ease symptoms is allowed, including within the prior 6 weeks; short courses during the study need approval.
  • Lasting or unstable moderate or worse side effects from earlier chemotherapy or radiation. Tiredness, hair loss, and moderate nerve damage from chemotherapy are exceptions.
  • Certain abnormal heart rhythms or electrical test results, or a personal or close family history of certain dangerous rhythms or sudden death. Atrial fibrillation with a controlled heart rate is allowed.
  • Heart failure in the study’s listed severity groups, or a heart attack or unstable chest pain within the past 6 months.
  • Medicines that affect heart rhythm and cannot be stopped or replaced in time, or recent medicines that strongly change how the liver protein CYP3A4 handles drugs. The waiting period is at least 14 days and may be longer.
  • Previous treatment with the selected drug that would be combined with EP0062.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (7)

CT

FL

MA

MI

TN

TX

VA