Status:
RECRUITING
EP102 Safety and Efficacy in METTL3 Modulation in Advanced Solid Tumors
Lead Sponsor:
Epics Therapeutics
Conditions:
Advanced Solid Tumor (Phase 1)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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)...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT07163325
Start Date
July 24 2025
End Date
November 1 2028
Last Update
September 9 2025
Active Locations (8)
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1
Institut Jules Bordet
Brussels, Belgium, 1070
2
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
3
Masaryk Memorial Cancer Institute
Brno, Czechia, 656 53
4
Olomouc University Hospital
Olomouc, Czechia, 77900