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

March 18, 2026 updated by: Ellipses Pharma

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

95

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron (VHIO)
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28223
        • Recruiting
        • NEXT Oncology Hospital Quironsalud
    • Madrid
  • United Kingdom
      • Liverpool, United Kingdom, CH63 4JY
        • Recruiting
        • The Clatterbridge Cancer Centre
        • Contact:
    • London
    • Wilmslow Rd
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Completed
        • Yale School of Medicine
    • Florida
      • Tampa, Florida, United States, 33612
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
          • Phone Number: 617-726-6500
    • Michigan
      • Detroit, Michigan, United States, 48202
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
    • Virginia
      • Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Module A - EP0062 Dose Finding
Patients are assigned to dose level cohorts to identify optimal dose and assess safety, tolerability and PK profile.
Drug: EP0062
EP0062 is an orally administered investigational selective androgen receptor modulator (SARM)
Experimental: Module B - EP0062+ standard of care targeted therapy (elacestrant).
3-6 patients enrolled, with possible expansion up to 25 patients.
Drug: EP0062
EP0062 is an orally administered investigational selective androgen receptor modulator (SARM)
Drug: Elacestrant
Oral SERD
Experimental: Module B - EP0062+ standard of care targeted therapy (everolimus/exemestrane)
3-6 patients enrolled, with possible expansion up to 25 patients.
Drug: EP0062
EP0062 is an orally administered investigational selective androgen receptor modulator (SARM)
Drug: Everolimus
mTOR Inhibitor
Drug: Exemestane
aromatase inhibitor
Experimental: Module B: EP0062 in combination with Abemaciclib and Fulvestrant
3-6 patients enrolled, with possible expansion up to 25 patients.
Drug: EP0062
EP0062 is an orally administered investigational selective androgen receptor modulator (SARM)
Drug: Abemaciclib
CDK4/6 inhibitor
Drug: Fulvestrant
Oral SERD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of dose-limiting toxicities (DLTs) during Cycle 1 of EP0062 treatment
Time Frame: first 28 days
Module A
first 28 days
Maximum tolerated dose (MTD) and doses for evaluation in the expansion cohorts
Time Frame: 1 year
Module A
1 year
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time Frame: up to 30 days after the end of treatment
Module A/B
up to 30 days after the end of treatment
Recommended clinical (dose (s) for combination therapy
Time Frame: 1 year
Module B
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma pharmacokinetic (PK) parameters - Half life
Time Frame: 1, 2, 4, 8, 24 and 48 hours during cycle 1
1, 2, 4, 8, 24 and 48 hours during cycle 1
Plasma pharmacokinetic (PK) parameters - Cmax
Time Frame: 1, 2, 4, 8, 24 and 48 hours during cycle 1
1, 2, 4, 8, 24 and 48 hours during cycle 1
Plasma pharmacokinetic (PK) parameters - Area under the curve (exposure)
Time Frame: 1, 2, 4, 8, 24 and 48 hours during cycle 1
1, 2, 4, 8, 24 and 48 hours during cycle 1
Tumour response
Time Frame: screening and every 8 weeks up to 12 months
screening and every 8 weeks up to 12 months
Clinical Benefit Rate (CBR)
Time Frame: every 8 weeks up to 12 months
every 8 weeks up to 12 months
Objective Response Rate (ORR)
Time Frame: every 8 weeks up to 12 months
every 8 weeks up to 12 months
Duration of Response (DOR)
Time Frame: every 8 weeks up to 12 months
every 8 weeks up to 12 months
Progression-free survival (PFS)
Time Frame: every 8 weeks up to 12 months
every 8 weeks up to 12 months
Overall Survival (OS)
Time Frame: every 8 weeks up to 12 months
every 8 weeks up to 12 months
Relationship between EP0062 efficacy parameters and the level of Androgen Receptor expression and Androgen Receptor : Oestrogen Receptor ratio
Time Frame: every 8 weeks up to 12 months
every 8 weeks up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ellipses Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2023

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

October 3, 2022

First Submitted That Met QC Criteria

October 5, 2022

First Posted (Actual)

October 10, 2022

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EP0062-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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