Hormone Receptor-positive Breast CancerPhase 1/2NCT05573126
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 Phase 1/2 study testing EP0062, Elacestrant and Everolimus in people with Hormone Receptor-positive Breast Cancer and Hormone Receptor Positive HER-2 Negative Breast Cancer, run by Ellipses Pharma at 14 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hormone Receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- EP0062, Elacestrant and Everolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 11 Jan 2023to Feb 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 18 years or older at the time of informed consent
- 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
- 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
- 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
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- 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
- Postmenopausal, as defined by at least one of the following:
- Age over 60 years
- 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)
- FSH and oestradiol in the postmenopausal ranges (as per local practice) in women aged <55 years who have undergone hysterectomy
- Prior bilateral oophorectomy
- Module B arm 1: patients who have progressed on ≤ 2 prior lines of endocrine therapy, including a prior CDK4/6 inhibitor.
- Module B arm 2: patients who have progressed on ≤ 2 prior lines of endocrine therapy in advanced/metastatic setting, including prior CDK4/6 inhibitor
- 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.
Who cannot join
- 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 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
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- Currently taking testosterone, methyltestosterone, oxandrolone, oxymetholone, danazol, fluoxymesterone, testosterone-like agents (e.g., dehydroepiandrosterone, androstenedione, and other androgenic compounds, including herbals), or antiandrogens
- 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
- 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
- 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
- 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
- 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
- Congestive heart failure Grades II-IV according to the New York Heart Association at the time of screening
- Myocardial infarction or unstable angina within the previous 6 months
- 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
- Prior treatment with selected combination agent
Trial locations and contacts
14 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 3 countries
United States7 sites, 6 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Texas Oncology Baylor University Medical Center
Dallas, Texas, 75246
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
- Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
- Completed
Yale School of Medicine
New Haven, Connecticut, 06520
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Spain4 sites, 4 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron (VHIO)
Barcelona, 08035
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
- Recruiting
NEXT Oncology Hospital Quironsalud
Madrid, 28223
- Recruiting
Hospital 12 de Octubre
Usera, Madrid, 28041
United Kingdom3 sites, 3 recruiting
- Recruiting
The Clatterbridge Cancer Centre
Liverpool, CH63 4JY
- Recruiting
Sarah Cannon Research Institute UK
London, London, W1G 6AD
- Recruiting
The Christie NHS Foundation Trust
Manchester, Wilmslow Rd, M20 4BX
About this study
Official title: 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
Read the 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).
- Conditions
- Hormone Receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer
- Being tested
- EP0062, Elacestrant, Everolimus, Abemaciclib, Fulvestrant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP0062Drug
EP0062 is an orally administered investigational selective androgen receptor modulator (SARM)
ElacestrantDrug
Oral SERD
EverolimusDrug
mTOR Inhibitor
AbemaciclibDrug
CDK4/6 inhibitor
FulvestrantDrug
Oral SERD
ExemestaneDrug
aromatase inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Module A - EP0062 Dose Finding | Experimental | Patients are assigned to dose level cohorts to identify optimal dose and assess safety, tolerability and PK profile. Receives: Drug: EP0062 |
| Module B - EP0062+ standard of care targeted therapy (elacestrant). | Experimental | 3-6 patients enrolled, with possible expansion up to 25 patients. Receives: Drug: EP0062; Drug: Elacestrant |
| Module B - EP0062+ standard of care targeted therapy (everolimus/exemestane) | Experimental | 3-6 patients enrolled, with possible expansion up to 25 patients. Receives: Drug: EP0062; Drug: Everolimus; Drug: Exemestane |
| Module B: EP0062 in combination with Abemaciclib and Fulvestrant | Experimental | 3-6 patients enrolled, with possible expansion up to 25 patients. Receives: Drug: EP0062; Drug: Abemaciclib; Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs) during Cycle 1 of EP0062 treatment
Module A
Measured: first 28 days
Maximum tolerated dose (MTD) and doses for evaluation in the expansion cohorts
Module A
Measured: 1 year
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Module A/B
Measured: up to 30 days after the end of treatment
Recommended clinical (dose (s) for combination therapy
Module B
Measured: 1 year
Secondary outcomes (10)
Plasma pharmacokinetic (PK) parameters - Half life
Measured: 1, 2, 4, 8, 24 and 48 hours during cycle 1
Plasma pharmacokinetic (PK) parameters - Cmax
Measured: 1, 2, 4, 8, 24 and 48 hours during cycle 1
Plasma pharmacokinetic (PK) parameters - Area under the curve (exposure)
Measured: 1, 2, 4, 8, 24 and 48 hours during cycle 1
Tumour response
Measured: screening and every 8 weeks up to 12 months
Clinical Benefit Rate (CBR)
Measured: every 8 weeks up to 12 months
Objective Response Rate (ORR)
Measured: every 8 weeks up to 12 months
Duration of Response (DOR)
Measured: every 8 weeks up to 12 months
Progression-free survival (PFS)
Measured: every 8 weeks up to 12 months
Overall Survival (OS)
Measured: 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
Measured: every 8 weeks up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start11 Jan 2023
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Receptor-positive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ellipses Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573126
- Sponsor's protocol ID
- EP0062-101
- Status last verified
- Jun 2026
- First submitted
- 3 Oct 2022
- Last updated
- 22 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05573126
- Acronym / sponsor ID
- EP0062-101
- Conditions
- Hormone Receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Ellipses PharmaIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Module A - EP0062 Dose Finding | Experimental | Drug: EP0062Patients are assigned to dose level cohorts to identify optimal dose and assess safety, tolerability and PK profile. |
| Module B - EP0062+ standard of care targeted therapy (elacestrant). | Experimental | Drug: EP0062, Drug: Elacestrant3-6 patients enrolled, with possible expansion up to 25 patients. |
| Module B - EP0062+ standard of care targeted therapy (everolimus/exemestane) | Experimental | Drug: EP0062, Drug: Everolimus, Drug: Exemestane3-6 patients enrolled, with possible expansion up to 25 patients. |
| Module B: EP0062 in combination with Abemaciclib and Fulvestrant | Experimental | Drug: EP0062, Drug: Abemaciclib, Drug: Fulvestrant3-6 patients enrolled, with possible expansion up to 25 patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Women 18 years or older at the time of informed consent
- 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
- 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
- Biopsy-proven AR+ and ER+ breast cancer
- 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
Key exclusion criteria (16 listed)
- Prior anti-cancer or investigational drug treatment within the following time windows:
- Currently taking testosterone, methyltestosterone, oxandrolone, oxymetholone, danazol, fluoxymesterone, testosterone-like agents (e.g., dehydroepiandrosterone, androstenedione, and other androgenic compounds, including herbals), or antiandrogens
- 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
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EP0062EP0062 is an orally administered investigational selective androgen receptor modulator (SARM) | Drug | Module A - EP0062 Dose Finding, Module B - EP0062+ standard of care targeted therapy (elacestrant)., Module B - EP0062+ standard of care targeted therapy (everolimus/exemestane), Module B: EP0062 in combination with Abemaciclib and Fulvestrant |
| ElacestrantOral SERD | Drug | Module B - EP0062+ standard of care targeted therapy (elacestrant). |
| EverolimusmTOR Inhibitor | Drug | Module B - EP0062+ standard of care targeted therapy (everolimus/exemestane) |
| AbemaciclibCDK4/6 inhibitor | Drug | Module B: EP0062 in combination with Abemaciclib and Fulvestrant |
| FulvestrantOral SERD | Drug | Module B: EP0062 in combination with Abemaciclib and Fulvestrant |
| Exemestanearomatase inhibitor | Drug | Module B - EP0062+ standard of care targeted therapy (everolimus/exemestane) |
Primary outcome
Incidence of dose-limiting toxicities (DLTs) during Cycle 1 of EP0062 treatment
Time frame: first 28 days
Module A
Maximum tolerated dose (MTD) and doses for evaluation in the expansion cohorts
Time frame: 1 year
Module A
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
Recommended clinical (dose (s) for combination therapy
Time frame: 1 year
Module B
10 secondary outcomes
Plasma pharmacokinetic (PK) parameters - Half life
Time frame: 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
Plasma pharmacokinetic (PK) parameters - Area under the curve (exposure)
Time frame: 1, 2, 4, 8, 24 and 48 hours during cycle 1
Tumour response
Time frame: screening and every 8 weeks up to 12 months
Clinical Benefit Rate (CBR)
Time frame: every 8 weeks up to 12 months
Objective Response Rate (ORR)
Time frame: every 8 weeks up to 12 months
Duration of Response (DOR)
Time frame: every 8 weeks up to 12 months
Progression-free survival (PFS)
Time frame: every 8 weeks up to 12 months
Overall Survival (OS)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EP0062, Elacestrant and Everolimus in people with Hormone Receptor-positive Breast Cancer and Hormone Receptor Positive HER-2 Negative Breast Cancer, run by Ellipses Pharma at 14 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Team (+44 (0)20 3743 0992, Enquiries@ellipses.life), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (DLTs) during Cycle 1 of EP0062 treatment (time frame: first 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.