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EP102 Safety and Efficacy in METTL3 Modulation in Advanced Solid Tumors
Sponsor: Epics Therapeutics
Summary
This the first-in-human (FIH) study for the Investigational Medicinal Product (IMP) EP102, is designed to explore the maximum tolerated dose (MTD), the overall safety profile, its pharmacokinetic (PK) / pharmacodynamic (PD) profile, and an exploratory evaluation of antitumor activity in participants with advanced solid tumors, who have no available standard therapy or who have failed standard therapies. This study will inform on recommended doses for further studies, e.g. dose optimization studies and / or efficacy and safety studies.
Official title: A Phase 1 Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered EP102 Monotherapy in Participants With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2025-07-24
Completion Date
2028-11
Last Updated
2025-09-09
Healthy Volunteers
No
Conditions
Interventions
EP102
EP102 will be administered orally
Locations (8)
Institut Jules Bordet
Brussels, Belgium
Cliniques universitaires Saint-Luc
Brussels, Belgium
Masaryk Memorial Cancer Institute
Brno, Czechia
Olomouc University Hospital
Olomouc, Czechia
Netherlands Cancer Institute (NKI)
Amsterdam, Netherlands
Hospital Universitari Vall d'Hebron - Vall d'Hebron Institute of Oncology
Barcelona, Spain
START Madrid - CIOCC
Madrid, Spain
Hospital Universitario de Santiago de Compostela
Santiago de Compostela, Spain