Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Ellipses Pharma
Study ID
NCT05573126
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EP0062 — DRUG
    EP0062 is an orally administered investigational selective androgen receptor modulator (SARM)
  • Elacestrant — DRUG
    Oral SERD
  • Everolimus — DRUG
    mTOR Inhibitor
  • Abemaciclib — DRUG
    CDK4/6 inhibitor
  • Fulvestrant — DRUG
    Oral SERD
  • Exemestane — DRUG
    aromatase inhibitor

Study Details

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

Key Dates

First listed
Oct 10, 2022
Start date
Jan 11, 2023
Status verified
Jun 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
95 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Module A - EP0062 Dose Finding
    Patients are assigned to dose level cohorts to identify optimal dose and assess safety, tolerability and PK profile.
  • Experimental: Module B - EP0062+ standard of care targeted therapy (elacestrant).
    3-6 patients enrolled, with possible expansion up to 25 patients.
  • Experimental: Module B - EP0062+ standard of care targeted therapy (everolimus/exemestane)
    3-6 patients enrolled, with possible expansion up to 25 patients.
  • Experimental: Module B: EP0062 in combination with Abemaciclib and Fulvestrant
    3-6 patients enrolled, with possible expansion up to 25 patients.

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) during Cycle 1 of EP0062 treatment [ Time Frame: first 28 days ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Yale School of MedicineNew HavenConnecticut06520-
Moffitt Cancer CenterTampaFlorida33612-
Massachusetts General HospitalBostonMassachusetts02114-
Henry Ford HospitalDetroitMichigan48202-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Texas Oncology Baylor University Medical CenterDallasTexas75246-
Virginia Cancer SpecialistsFairfaxVirginia22031-

Find similar trials in New Haven, CT

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Yale School of Medicine· New Haven, CTMoffitt Cancer Center· Tampa, FLMassachusetts General Hospital· Boston, MAHenry Ford Hospital· Detroit, MISarah Cannon Research Institute· Nashville, TNTexas Oncology Baylor University Medical Center· Dallas, TX

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