Ireland
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Recruiting Phase 1

EP102 Safety and Efficacy in METTL3 Modulation in Advanced Solid Tumors

NCT07163325 · tracked via the Priya Life Science Spain tracker
Sponsor
Epics Therapeutics
Phase
Phase 1
Started
2025-07-24
Last updated
2026-06-11

Condition(s) studied

Advanced Solid Tumor (Phase 1)

Investigational drug(s) / intervention(s)

EP102

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Participants must have a histological diagnosis of locally advanced or metastatic malignant solid tumors of one of the following cancer types: * ovarian cancer * cervical cancer * endometrial cancer * testicular cancer * cholangiocarcinoma * thyroid cancer * parathyroid cancer * adrenal cancer * pancreatic cancer * non-small-cell lung cancer (NSCLC) * head-and neck cancer * renal cell cancer * urethral cancer * bladder cancer * colorectal cancer * gastric cancer * esophageal cancer * triple-negative breast cancer * thymoma * soft tissue sarcoma * Participants must have failed (i.e. progressed on, or been intolerant to standard treatment), or no standard treatment must exist, or they must have refused standard treatment. All participants must have received at least one prior line of systemic therapy. * Participants must have at least one measurable lesion per RECIST v1.1. * Participant must have a life expectancy of at least 12 weeks. Exclusion Criteria: * Participants with an active severe infection or unexplained fever \> 38.5°C during screening or on the first day of study drug administration are excluded. However, at the Investigator's discretion, participants with tumor-related fever may be enrolled. * Participants with known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection (hepatitis B surface antigen (HBsAg) positive in serum), or active hepatitis C virus (HCV) infection (HCV RNA positive in serum). * Participants with known dysphagia, short-bowel syndrome, gastroparesis, or any condition that may impair the ingestion or gastrointestinal absorption of orally administered drugs. * Pregnant or breastfeeding participants. * Participants who have received IMP or devices in other clinical trials within four weeks before the first dose. * Participants with prior exposure to selective METTL3 inhibitor therapy.

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)

FacilityCityRegionStatus
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
Official registry record

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