EP102 Safety and Efficacy in METTL3 Modulation in Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
EP102: EP102 will be administered orally
Study 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
Primary outcome measure(s)
- To assess the safety and tolerability of EP102 monotherapy — Up to 21 Days after first administration
The incidence of adverse drug reactions (ADRs) and serious adverse drug reactions (SARs) during study period - To assess the safety and tolerability of EP102 monotherapy — Up to 21 Days after first administration
The incidence of all treatment-emergent AEs and treatment-emergent serious adverse events (SAEs) during study period - Explore the maximum tolerated dose (MTD) and recommended doses of EP102 monotherapy for subsequent studie — Up to 21 Days after first administration
Incidence of Dose Limiting Toxicities (DLT)
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| Institut Jules Bordet | Brussels | Belgium | Recruiting |
| Cliniques universitaires Saint-Luc | Brussels | Belgium | Recruiting |
| Universitair Ziekenhuis Gent (UZ Gent) - Drug Research Unit Gent (DRUG) | Ghent | Belgium | Recruiting |
| Leuven Cancer Institute (LKI) | Leuven | Belgium | Recruiting |
| Masaryk Memorial Cancer Institute | Brno | Czechia | Recruiting |
| Olomouc University Hospital | Olomouc | Czechia | Recruiting |
| Netherlands Cancer Institute (NKI) | Amsterdam | Netherlands | Recruiting |
| University Medical Center Groningen, University of Groningen Department of Medical Oncology | Groningen | Netherlands | Recruiting |
| Hospital Universitari Vall d'Hebron - Vall d'Hebron Institute of Oncology | Barcelona | Spain | Recruiting |
| START Madrid - CIOCC | Madrid | Spain | Recruiting |
| Hospital Universitario de Santiago de Compostela | Santiago de Compostela | Spain | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07163325 on ClinicalTrials.gov ↗ ← All trials in Spain