Study of EP0062 for Advanced or Metastatic Breast Cancer
This study is testing a new drug called EP0062, alone and with other standard treatments like Elacestrant, Everolimus, Abemaciclib, and Fulvestrant. It's for women aged 18 or older with advanced or metastatic breast cancer that is hormone receptor-positive (AR+/ER+) and HER-2 negative. The main goals are to find the safest and most effective dose of EP0062, and to see how well it works and if it causes any side effects. The study has already completed its first phase to find the best dose, and is now moving into a phase to further test that dose.
- Study design
- This is an open-label, Phase 1/2 study, meaning you and your doctors will know which treatment you are receiving. It aims to enroll 95 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be monitored for side effects for up to 30 days after your treatment ends. The maximum tolerated dose will be assessed for up to 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05573126
Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentEllipses Pharma
~95 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:EP0062ElacestrantEverolimusAbemaciclibFulvestrantExemestane
At a glance
Recruiting sites
13 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose-limiting toxicities (DLTs) during Cycle 1 of EP0062 treatment
Measured over first 28 days
+3 more outcomes measured
Conditions
Where it's being run
14 sites across 12 statesSpain3
Connecticut1
Florida1
Massachusetts1
Michigan1
Tennessee1
Texas1
Virginia1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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:
Exclusion
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
What this trial measures
- Incidence of dose-limiting toxicities (DLTs) during Cycle 1 of EP0062 treatmentfirst 28 days
Module A
- Maximum tolerated dose (MTD) and doses for evaluation in the expansion cohorts1 year
Module A
- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)up to 30 days after the end of treatment
Module A/B
- Recommended clinical (dose (s) for combination therapy1 year
Module B