EP102 Safety and Efficacy in METTL3 Modulation in Advanced Solid Tumors
Recruiting now · Phase 1
Conditions studied: Advanced Solid Tumor (Phase 1)
In brief
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.
Key facts
- Study ID
- NCT07163325
- Run by
- Epics Therapeutics
- People needed
- 48
- Starts
- 2025-07-24
- Expected to finish
- 2028-11-01
- Last updated by the study team
- 2026-06-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Institut Jules Bordet — Brussels, Belgium (enrolling)
- Cliniques universitaires Saint-Luc — Brussels, Belgium (enrolling)
- Universitair Ziekenhuis Gent (UZ Gent) - Drug Research Unit Gent (DRUG) — Ghent, Belgium (enrolling)
- Leuven Cancer Institute (LKI) — Leuven, Belgium (enrolling)
- Masaryk Memorial Cancer Institute — Brno, Czechia (enrolling)
- Olomouc University Hospital — Olomouc, Czechia (enrolling)
- Netherlands Cancer Institute (NKI) — Amsterdam, Netherlands (enrolling)
- University Medical Center Groningen, University of Groningen Department of Medical Oncology — Groningen, Netherlands (enrolling)
- Hospital Universitari Vall d'Hebron - Vall d'Hebron Institute of Oncology — Barcelona, Spain (enrolling)
- START Madrid - CIOCC — Madrid, Spain (enrolling)
- Hospital Universitario de Santiago de Compostela — Santiago de Compostela, Spain (enrolling)
Full record on ClinicalTrials.gov
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