Clinical trialPhase 1Recruiting
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
- Outcome
- Ongoing
- Phase
- Phase 1
- Status
- Recruiting
- Study type
- Interventional
- Start
- 24 July 2025
- Expected end
- November 2028
- Enrollment
- 48 participants
- Sites
- 11
- Primary outcomes
- To assess the safety and tolerability of EP102 monotherapy; To assess the safety and tolerability of EP102 monotherapy; Explore the maximum tolerated dose (MTD) and recommended doses of EP102 monotherapy for subsequent studie
- Sponsor
- Industry
- Results posted
- No
- Last update
- 11 June 2026
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Brief summary public domain (ClinicalTrials.gov)
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.