Phase 1/2 Study of EP0062 for Patients with Advanced or Metastatic Androgen Receptor Positive Breast Cancer

Sponsor: Ellipses Pharma

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05573126

Provider View

This clinical trial is testing a new drug, EP0062, to find the best dose and evaluate its safety and effectiveness in women with advanced or metastatic breast cancer that is positive for androgen receptors and estrogen receptors, but negative for HER2.

Patient Parameters

Program Overview

The purpose of this study is to determine the best dose of EP0062 when used alone and to assess its safety, how well it is tolerated, how it moves through the body, and its effectiveness in treating women with advanced or metastatic breast cancer that is positive for androgen receptors (AR+) and estrogen receptors (ER+), but negative for HER2.

Description

Vosilasarm (EP0062) is being investigated in this modular, interventional, open label, Phase 1/2 dose finding, optimisation and expansion study to determine the optimal dose of Vosilasarm given as monotherapy and for evaluation in combination with standard-of-care therapies in patients with Relapsed Locally Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer. Module A (phase 1 dose finding) has completed and an optimal dose has been selected for module B (phase 2 expansion).

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older.
  • Diagnosed with advanced or metastatic breast cancer that has returned or spread, and no standard treatment is available or suitable.
  • Able to provide a previous tumor sample or willing to undergo a new biopsy if needed.
  • Cancer must be AR+ and ER+.
    • For some parts of the study, AR+ is defined as at least 10% AR staining.
    • For other parts, AR+ is defined as at least 30% AR staining.
  • Cancer must be HER2-negative.
  • Must be postmenopausal, which can be confirmed by:
    • Being over 60 years old.
    • Having no periods for over a year and having certain hormone levels.
    • Having certain hormone levels if under 55 and had a hysterectomy.
    • Having had both ovaries removed.

Exclusion Criteria

  • Recent treatment with certain cancer drugs:
    • Chemotherapy within 21 days before starting the study drug.
    • Other cancer drugs within a specific time frame before starting the study drug.
    • Hormone therapies like tamoxifen within 14 days before starting the study drug.
  • Currently taking certain hormone or testosterone-like medications.
  • Recent radiation therapy within 14 days before starting the study drug, unless approved for short-term relief.
  • Unresolved serious side effects from previous treatments.
  • Certain heart conditions or abnormal heart rhythms.
  • Taking medications that affect heart rhythm that cannot be stopped before starting the study drug.
  • Severe heart failure or recent heart attack or unstable chest pain.
  • Taking medications that strongly affect liver enzymes within a specific time frame before starting the study drug.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.