A modular, Phase I/II of EP0031 in Patients with Advanced RET-altered Malignancies
Research type
Research Study
Full title
A Modular, Open-label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of EP0031 in Patients with Advanced RET-altered Malignancies.
IRAS ID
1006061
Contact name
Liz Clark
Contact email
Sponsor organisation
Ellipses Pharma Limited
Eudract number
2022-001258-43
Clinicaltrials.gov Identifier
Research summary
This is the first study of EP0031 to be performed in humans in the UK (there is an ongoing Phase I/II study in China – NCT05265091). All patients in the study need to have a cancer with an abnormal RET gene. The purpose of the first part of the study is to find a dose of EP0031 that can be administered safely to patients with different kinds of solid tumours. In the second part of the study, patients will be divided up into groups depending on whether they have had a first general RET-specific inhibitor like pralsetinib or selpercatinib or not and also according to what kind of cancer they have: lung cancer, thyroid cancer, or other cancers. The main purpose of the second part of the study is to see whether EP0031 has an anti-cancer effect. All patients will take EP0031 every day by mouth for the duration of the study. Patients will stop taking EP0031 if their cancer grows significantly or they experience intolerable side effects. To be enrolled in the study, patients need to meet the study’s inclusion and exclusion criteria and sign informed consent. About 265 patients will take part in this research trial. This is a commercial trial fully funded by the sponsor, Ellipses Pharma Limited who are based in the United Kingdom.
REC name
East of England - Essex Research Ethics Committee
REC reference
23/EE/0177
Date of REC Opinion
7 Sep 2023
REC opinion
Further Information Favourable Opinion