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

NCT05573126 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2026-03-20

No results posted yet for this study

Summary

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

Conditions

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

Sponsors & Collaborators

  • Ellipses Pharma

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-11
Primary Completion
2028-02-29
Completion
2028-02-29
FDA Drug
Yes

Countries

  • United States
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05573126 on ClinicalTrials.gov