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Study on the Safety and Effects of Vosilasarm Alone and in Combination for Patients with Relapsed Advanced or Metastatic Breast Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as breast cancer, specifically in patients whose cancer has returned or spread to other parts of the body. The study is investigating a new treatment called EP0062, which is a tablet taken by mouth. EP0062 is also known by its chemical name, vosilasarm, and is a type of medication called an oral selective androgen receptor modulator. This trial aims to understand how safe and tolerable EP0062 is when used alone and in combination with other treatments.

The study is divided into two parts. In the first part, researchers will determine the best dose of EP0062 when used by itself. In the second part, they will explore how EP0062 works when combined with other standard treatments for breast cancer. The goal is to find the most effective and safe way to use EP0062 for patients with AR-positive, HER2-negative, and ER-positive breast cancer. These terms refer to specific characteristics of the cancer cells that can influence how the cancer behaves and responds to treatment.

Throughout the study, participants will be closely monitored for any side effects and how their cancer responds to the treatment. The trial will help determine the optimal dose of EP0062 and assess its potential benefits for patients with advanced breast cancer. This research is important for developing new treatment options for individuals with this type of cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be informed about the trial's objectives and procedures. Written informed consent is required before any study-specific procedures begin.

  2. Step 2

    Module a: initial treatment phase

    The patient will receive the medication EP0062 in the form of a tablet for oral use. The specific dosage and frequency will be determined by the study team based on safety and tolerability assessments.

    The primary goal during this phase is to evaluate the safety and tolerability of EP0062 and to determine the optimal dose for further evaluation.

  3. Step 3

    Module a: monitoring and assessment

    Throughout the treatment, the patient will be monitored for any dose-limiting toxicities and adverse events. This monitoring will occur during the first 28-day cycle of treatment.

    Regular assessments will be conducted to measure the patient's response to the treatment, including objective response rate, duration of response, and progression-free survival.

  4. Step 4

    Module b: combination therapy phase

    If the patient qualifies, they may proceed to Module B, where EP0062 will be administered in combination with other standard-of-care therapies.

    The focus in this phase is to evaluate the safety and tolerability of the combination therapy and to recommend clinical doses for this approach.

  5. Step 5

    Module b: ongoing monitoring

    Similar to Module A, the patient will be closely monitored for adverse events and the effectiveness of the combination therapy will be assessed.

    Key measures include the objective response rate, duration of response, and overall survival.

  6. Step 6

    Completion of the study

    The study is estimated to conclude by August 31, 2026. Upon completion, the patient will undergo final assessments to evaluate the overall impact of the treatment.

Who can join the trial?

16 criteria

  • Women who are 18 years or older.
  • Must have a confirmed diagnosis of **breast cancer** that has spread or is advanced, and no standard treatment is available or suitable.
  • Must have **AR+ HER2- and ER+ breast cancer**, confirmed by a biopsy. If a new biopsy is not possible, an older sample can be used if it's not more than 10 years old.
  • Must have a good general health status, as measured by a scale called **ECOG performance status**, with a score of 0 to 1.
  • Must be **postmenopausal**, based on specific criteria.
  • For Module A: Must have received certain types of hormone therapy for advanced cancer, including a combination with a **CDK 4/6 inhibitor**. For Module B: Must be suitable for combination treatment as standard care.
  • Must have received some form of **chemotherapy** for advanced cancer.
  • Must have **endocrine-therapy sensitive breast cancer**, meaning it responded well to hormone treatments in the past.
  • Must have measurable disease, which means the cancer can be measured or seen on scans.
  • Must have an estimated life expectancy of more than 3 months.
  • All other medical conditions must be stable and well-managed for at least 28 days before starting the study drug.
  • Must have adequate blood and organ function, based on specific criteria.
  • Must have a **left ventricular ejection fraction** greater than 50%, which is a measure of heart function.
  • Must be willing and able to participate in all study evaluations and procedures.
  • Must be able to understand and sign a consent form before any study-specific procedures.
  • For Module B: Must be able to receive combination treatments that are standard care, following all guidelines and precautions.

Who cannot join the trial?

4 criteria

  • Patients who are not female cannot participate in the study.
  • Patients who do not have breast cancer cannot participate in the study.
  • Patients who are not within the specified age range cannot participate in the study. The age range is typically defined in the study details.
  • Patients who are part of a vulnerable population, which means groups that may need special protection, are not included in this study.
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Investigated drugs

EP0062 is a new medication being studied for its safety and effectiveness in treating patients with a specific type of breast cancer that is relapsed, locally advanced, or metastatic. This type of breast cancer is characterized by being positive for androgen receptors (AR+), negative for human epidermal growth factor receptor 2 (HER2-), and positive for estrogen receptors (ER+). The study aims to find the best dose of EP0062 when used alone and to assess its safety when used in combination with other treatments.

What is already known about the treatment

EP0062 – EP0062 is an investigational medication currently being studied in a clinical trial for its potential use in treating breast cancer, specifically in patients with relapsed locally advanced or metastatic AR+/HER2-/ER+ breast cancer. It is administered as a monotherapy and in combination with other treatments, with the aim of determining its safety, tolerability, and optimal dosing. The medication is in the early stages of clinical research, focusing on its pharmacokinetics and efficacy. EP0062 is believed to work by targeting specific molecular pathways involved in cancer cell growth, although its exact mechanism of action is still under investigation. It falls under the pharmacological classification of targeted cancer therapies.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor that can often be felt as a lump. It typically begins in the ducts or lobules of the breast and can spread to other parts of the body if not managed. The progression of breast cancer can vary, with some types growing slowly and others more rapidly. It is often categorized by stages, which describe the size of the tumor and the extent of its spread. Early detection is crucial for managing the disease effectively. Breast cancer can affect both men and women, although it is much more common in women.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-507738-26-00Protocol codeEP0062-101Estimated enrolment60 patientsSponsorEllipses Pharma Limited

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