RecruitingPhase 1NCT07163325

EP102 Safety and Efficacy in METTL3 Modulation in Advanced Solid Tumors

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


Sponsor

Epics Therapeutics

Enrollment

48 participants

Start Date

Jul 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called EP102 for people with advanced solid tumor (phase 1). The study is currently recruiting participants at 11 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEP102

EP102 will be administered orally


Locations(11)

Institut Jules Bordet

Brussels, Belgium

Cliniques universitaires Saint-Luc

Brussels, Belgium

Universitair Ziekenhuis Gent (UZ Gent) - Drug Research Unit Gent (DRUG)

Ghent, Belgium

Leuven Cancer Institute (LKI)

Leuven, Belgium

Masaryk Memorial Cancer Institute

Brno, Czechia

Olomouc University Hospital

Olomouc, Czechia

Netherlands Cancer Institute (NKI)

Amsterdam, Netherlands

University Medical Center Groningen, University of Groningen Department of Medical Oncology

Groningen, 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

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NCT07163325


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