A Phase 1/2 study in Patients with Relapsed Locally Advanced or Metastatic Breast Cancer
Research type
Research Study
Full 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
IRAS ID
1007542
Contact name
Andrew Mazur
Contact email
Sponsor organisation
Ellipses Pharma Limited
Eudract number
2022-002895-35
Research summary
This study is investigating the safety and effectiveness of a new formulation of the experimental treatment, EP0062, in patients with
breast cancer that contains a specific protein, and which has relapsed or spread. The study consists of three parts:
Part 1 is a dose escalation part, during which increasing dose levels of EP0062 will be tested to investigate if they are safely
tolerated. Up to two dose levels which are found to be the best during this phase of testing will then be used in Parts 2 and 3. In Part
1, we will also investigate what the body does to the drug (known as pharmacokinetics).
In Part 2, we will continue to investigate the safety and tolerability of EP0062 at the dose(s) selected in Part 1 and also evaluate the
effects of EP0062 on cancer.
In Part 3, we will assess the safety of the new formulation of EP0062 in combination with other established therapies to see if they
are safe and tolerated and to determine the best dose of EP0062 to be used in combinations.
Approximately 128 patients will be enrolled in the study in about 9 sites in the US and UK.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
23/NE/0121
Date of REC Opinion
13 Oct 2023
REC opinion
Further Information Favourable Opinion