Trials / Recruiting
RecruitingNCT05573126
Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
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 as Monotherapy and in Combination in Patients With Relapsed Locally Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 95 (estimated)
- Sponsor
- Ellipses Pharma · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Detailed description
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 EP0062 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).
Conditions
- Hormone Receptor-positive Breast Cancer
- Hormone Receptor Positive HER-2 Negative Breast Cancer
- Metastatic Breast Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-01-11
- Primary completion
- 2028-02-01
- Completion
- 2028-02-01
- First posted
- 2022-10-10
- Last updated
- 2026-03-20
Locations
14 sites across 3 countries: United States, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05573126. Inclusion in this directory is not an endorsement.