NCT05573126 · Ellipses Pharma
Phase 1/2 Study to Evaluate Vosilasarm (EP0062) as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
What this study is about
The aim of this study is to identify the optimal dose for Vosilasarm (EP0062) as treatment given alone and in combination with standard-of-care therapies to assess its Safety, Tolerability, how the drug moves through the body, and effectiveness in Patients with Relapsed Locally Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
View original scientific description
The aim of this study is to identify the optimal dose for Vosilasarm (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
Interventions
DRUG
EP0062
EP0062 is an orally administered investigational selective androgen receptor modulator (SARM)
DRUG
Elacestrant
Oral SERD
DRUG
Everolimus
mTOR Inhibitor
DRUG
Abemaciclib
CDK4/6 inhibitor
DRUG
Fulvestrant
Oral SERD
DRUG
Exemestane
aromatase inhibitor
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 an
Where
- New Haven, Connecticut
- Tampa, Florida
- Boston, Massachusetts
- Detroit, Michigan
- Nashville, Tennessee
- Dallas, Texas
- Fairfax, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations