ClinicaliQ Trial Snapshot
- 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 • Phase I • Oncology • NCT05573126.
- What is being tested: EP0062, a novel therapeutic agent, is being evaluated as a single agent and in combination with standard-of-care treatments to determine optimal dosing, safety profile, and anti-tumour efficacy in advanced breast cancer.
- Patient eligibility overview: The trial recruits patients with relapsed, locally advanced, or metastatic breast cancer that is androgen receptor-positive (AR+), HER-2 negative (HER-2-), and oestrogen receptor-positive (ER+), representing a specific molecular subtype requiring targeted investigation.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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
Eligibility Snapshot
- : 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.