Actively Recruiting
EP102 Safety and Efficacy in METTL3 Modulation in Advanced Solid Tumors
Led by Epics Therapeutics · Updated on 2025-09-09
48
Participants Needed
8
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
EP102 Safety and Efficacy in METTL3 Modulation in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have a confirmed diagnosis of locally advanced or metastatic malignant solid tumors including ovarian, cervical, endometrial, testicular, cholangiocarcinoma, thyroid, parathyroid, adrenal, pancreatic, non-small-cell lung cancer, head and neck, renal cell, urethral, bladder, colorectal, gastric, esophageal, triple-negative breast cancer, thymoma, or soft tissue sarcoma
- Participants must have failed standard treatment, have no standard treatment available, or have refused standard treatment
- Participants must have received at least one prior line of systemic therapy
- Participants must have at least one measurable lesion according to RECIST v1.1
- Participants must have a life expectancy of at least 12 weeks
You will not qualify if you...
- Participants with active severe infection or unexplained fever above 38.5°C during screening or on the first day of drug administration, except tumor-related fever at Investigator's discretion
- Participants with known HIV infection, active hepatitis B (HBsAg positive), or active hepatitis C infection
- Participants with dysphagia, short-bowel syndrome, gastroparesis, or any condition impairing oral drug ingestion or absorption
- Pregnant or breastfeeding participants
- Participants who received investigational medicinal products or devices in other clinical trials within 4 weeks before first dose
- Participants with prior exposure to selective METTL3 inhibitor therapy
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Institut Jules Bordet
Brussels, Belgium, 1070
Actively Recruiting
2
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
3
Masaryk Memorial Cancer Institute
Brno, Czechia, 656 53
Actively Recruiting
4
Olomouc University Hospital
Olomouc, Czechia, 77900
Actively Recruiting
5
Netherlands Cancer Institute (NKI)
Amsterdam, Netherlands, 1066 CX
Actively Recruiting
6
Hospital Universitari Vall d'Hebron - Vall d'Hebron Institute of Oncology
Barcelona, Spain, 8035
Actively Recruiting
7
START Madrid - CIOCC
Madrid, Spain, 28050
Actively Recruiting
8
Hospital Universitario de Santiago de Compostela
Santiago de Compostela, Spain, 15706
Actively Recruiting
Research Team
C
Clinical Trial Liaison
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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