NCT07163325

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Epics Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumor (Phase 1)

Interventions

Type	Name	Description
DRUG	EP102	EP102 will be administered orally

Timeline

• Start date: 2025-07-24
• Primary completion: 2027-11-01
• Completion: 2028-11-01
• First posted: 2025-09-09
• Last updated: 2025-09-09

Locations

8 sites across 4 countries: Belgium, Czechia, Netherlands, Spain