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

Brief description of study

EP0031-101 is an interventional, modular, multi-arm, multi-centre, open-label Phase I/II study to investigate the safety, tolerability, PK, and PD of EP0031, to determine the RP2D of EP0031, and to determine preliminary efficacy of EP0031 in defined patient populations with RET-altered malignancies. The design consists of a core study protocol and individual Modules, as follows: ? Module A: Monotherapy dose escalation and RP2D optimisation in patients with RETaltered solid tumours (including a paired biopsy cohort) ? Module B: Dose-expansion cohorts will be opened to further explore the safety and tolerability and provide preliminary efficacy data in selected patient populations with RET-altered tumours ? Module C: Further dose expansion and initial efficacy investigation in patients who have progressed following first-generation SRI therapy


Clinical Study Identifier: s23-00226
ClinicalTrials.gov Identifier: NCT05443126
Principal Investigator: Salman Rafi Punekar.
Other Investigators: Samantha VanMaanen, Jessica Wang, Elaine Shum, Carol M Lee, Jonathan B Kahn, Gabrielle Fridman, Joshua K Sabari, David Mendoza, Natalia Cherkassky, Sally Lau, Avital Benson, Melissa L Martinez, Zujun Li, Vamsidhar Velcheti.


If you are registered as a volunteer, please log in to contact the study team/express interest in this study.

Contact the research team to learn more about this study.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.