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Phase 1/2 Study to Evaluate EP0062 in Patients With Relapsed Locally Advanced or Metastatic Androgen Receptor Positive (AR+)/HER2-/ER+ Breast Cancer

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ClinicalTrials.gov Identifier: NCT05573126
Recruitment Status : Not yet recruiting
First Posted : October 10, 2022
Last Update Posted : October 10, 2022
Sponsor:
Information provided by (Responsible Party):
Ellipses Pharma

Brief Summary:
The aim of this study is to identify the optimal dose for EP0062 as monotherapy and to assess its Safety, Tolerability, Pharmacokinetics, and Efficacy in Patients with Relapsed Locally Advanced or Metastatic AR+/HER2-/ER+ Breast Cancer

Condition or disease Intervention/treatment Phase
Hormone Receptor-positive Breast Cancer Hormone Receptor Positive HER-2 Negative Breast Cancer Metastatic Breast Cancer Drug: EP0062 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Modular, Open-Label, Multi-Centre Phase 1/2 Dose-Finding, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0062 in Patients With Relapsed Locally Advanced or Metastatic AR+/HER2-/ER+ Breast Cancer
Estimated Study Start Date : December 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : March 2025


Arm Intervention/treatment
Experimental: Module B - EP0062 Dose level 1
Patients randomised to one of the 2 expansion doses selected from Module A, with up to 30 patients included per dose level, to further characterise the safety and efficacy of EP0062.
Drug: EP0062
EP0062 is an orally administered investigational selective androgen receptor modulator (SARM)

Experimental: Module B - EP0062 Dose level 2
Patients randomised to one of the 2 expansion doses selected from Module A, with up to 30 patients included per dose level, to further characterise the safety and efficacy of EP0062.
Drug: EP0062
EP0062 is an orally administered investigational selective androgen receptor modulator (SARM)




Primary Outcome Measures :
  1. Incidence of dose-limiting toxicities (DLTs) during Cycle 1 of EP0062 treatment [ Time Frame: first 28 days ]
    Module A

  2. Maximum tolerated dose (MTD) and doses for evaluation in the expansion cohorts [ Time Frame: 1 year ]
    Module A

  3. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: up to 30 days after the end of treatment ]

Secondary Outcome Measures :
  1. Plasma pharmacokinetic (PK) parameters - Half life [ Time Frame: 1, 2, 4, 8, 24 and 48 hours during cycle 1 ]
  2. Plasma pharmacokinetic (PK) parameters - Cmax [ Time Frame: 1, 2, 4, 8, 24 and 48 hours during cycle 1 ]
  3. Plasma pharmacokinetic (PK) parameters - Area under the curve (exposure) [ Time Frame: 1, 2, 4, 8, 24 and 48 hours during cycle 1 ]
  4. Tumour response [ Time Frame: screening and every 8 weeks up to 12 months ]
  5. Clinical Benefit Rate (CBR) [ Time Frame: every 8 weeks up to 12 months ]
  6. Objective Response Rate (ORR) [ Time Frame: every 8 weeks up to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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:

    1. Age over 60 years
    2. Amenorrhea > 12 months at the time of informed consent and an intact uterus, with follicle-stimulating hormone (FSH) and oestradiol in the postmenopausal ranges (as per local practice)
    3. FSH and oestradiol in the postmenopausal ranges (as per local practice) in women aged <55 years who have undergone hysterectomy
    4. Prior bilateral oophorectomy

Exclusion Criteria:

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
  4. Unresolved or unstable serious toxic side effects of prior chemotherapy or radiotherapy, i.e., ≥ Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except fatigue, alopecia, and Grade 2 chemotherapy-induced neuropathy
  5. Confirmed Corrected QT Interval by Fridericia (QTcF) > 470 ms on screening ECG, or history of torsades de pointes (TdP), or history of congenital long QT syndrome, or immediate family history of long QT syndrome, unexplained sudden death at a young age, or sudden cardiac death
  6. Any other clinically important abnormalities in rhythm, conduction, or morphology on resting ECG (e.g., complete left bundle branch block, third-degree heart block); rate-controlled atrial fibrillation is permitted
  7. Concomitant medications that prolong the corrected QT interval and/or increase the risk for TdP that cannot be discontinued or substituted with another drug within 5 half-lives or 14 days before the first dose of study drug, whichever is longer
  8. Congestive heart failure Grades II-IV according to the New York Heart Association at the time of screening
  9. Myocardial infarction or unstable angina within the previous 6 months
  10. Patients receiving medications that are known to be strong inhibitors or inducers of CYP3A4 within 5 half-lives or 14 days, whichever is longer, before the first dose of study drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05573126


Contacts
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Contact: Andrew Mazur +44 (0)20 3743 0992 andrew@ellipses.life

Locations
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United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Ellipses Pharma
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Responsible Party: Ellipses Pharma
ClinicalTrials.gov Identifier: NCT05573126    
Other Study ID Numbers: EP0062-101
First Posted: October 10, 2022    Key Record Dates
Last Update Posted: October 10, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases