RecruitingHormone Receptor-positive Breast CancerHormone Receptor Positive HER-2 Negative Breast CancerMetastatic Breast Cancer
Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
Eligible age
18+ yrs
Accepts
Women
Locations
7 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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
Sponsor: Ellipses Pharma
You may qualify if…
- ✓ 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:
You may not qualify if…
- ✕ 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
Where it's recruiting
Connecticut
New Haven
Florida
Tampa
Massachusetts
Boston
Michigan
Detroit
Tennessee
Nashville
Texas
Dallas
Virginia
Fairfax
Source: ClinicalTrials.gov · NCT05573126 · last updated 2026-06-22