Discovery, Optimization, and Preclinical Pharmacology of EP652, a METTL3 Inhibitor with Efficacy in Liquid and Solid Tumor Models.
Guillaume Dutheuil, Killian Oukoloff, Julien Korac...
https://pubmed.ncbi.nlm.nih.gov/39883878Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID07163325
A Phase 1 Study of Oral EP102 Monotherapy to Assess Safety, Dosage, and Activity in Advanced Solid Tumors
Led by Epics Therapeutics · Updated on 2025-09-09
48
Participants Needed
8
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating EP102, an investigational drug, in people with advanced solid tumors who have no standard treatment options or have not responded to prior therapies. This first-in-human study aims to find the highest safe dose of EP102, understand its safety and how the body processes the drug, and explore its potential anti-tumor effects. The findings will guide dosing for future research. Participants will receive EP102 taken by mouth in varying doses to identify the maximum tolerated dose and recommended doses for future studies. This open-label study involves dose escalation across several levels. The treatment period includes up to 21 days after the first dose for safety and pharmacokinetic assessments. During the study, participants will undergo regular evaluations including safety monitoring, blood tests to track how EP102 is absorbed and processed, and assessments of tumor response using standard criteria. Researchers will observe participants for up to 21 days after starting treatment to evaluate safety, pharmacodynamics, and preliminary anti-tumor activity. Additional follow-up extends until the study ends to monitor ongoing effects.
CONDITIONS
Brief Title
EP102 Safety and Efficacy in METTL3 Modulation in Advanced Solid Tumors
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Diagnosed with locally advanced or metastatic malignant solid tumors of specific cancer types including ovarian, cervical, endometrial, testicular, cholangiocarcinoma, thyroid, parathyroid, adrenal, pancreatic, non-small-cell lung, head and neck, renal cell, urethral, bladder, colorectal, gastric, esophageal, triple-negative breast, thymoma, or soft tissue sarcoma
- Have failed standard treatment, have no standard treatment available, or have refused standard treatment
- Received at least one prior line of systemic therapy
- Have at least one measurable lesion per RECIST v1.1
- Life expectancy of at least 12 weeks
You will not qualify if you...
- Active severe infection or unexplained fever above 38.5°C during screening or first study drug day, except tumor-related fever as judged by investigator
- Known HIV infection, active hepatitis B or C infection
- Known difficulty swallowing, short-bowel syndrome, gastroparesis, or conditions impairing oral drug absorption
- Pregnant or breastfeeding
- Received investigational medicinal products or devices in other trials within 4 weeks before first dose
- Prior exposure to selective METTL3 inhibitor therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 21 days after first administration
Participants receive oral EP102 monotherapy at escalating dose levels to assess safety, dosage, and activity.
Daily dosing with visits as scheduled for safety and pharmacokinetic assessments
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
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Research Team
C
Clinical Trial Liaison
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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