EP102 Safety and Efficacy in METTL3 Modulation in Advanced Solid Tumors

Not Applicable

Recruiting

• Conditions: Advanced Solid Tumor (Phase 1)
• Interventions: Drug: EP102

• Registration Number: NCT07163325
• Lead Sponsor: Epics Therapeutics

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) / 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-07-24
• Status Verified: 2025-08
• Study First Submitted: 2025-08-05
• Study First Submitted QC: 2025-09-01
• Last Update Submitted: 2025-09-01
• Study First Posted: 2025-09-09
• Last Update Posted: 2025-09-09
• Primary Completion: 2027-11
• Study Completion: 2028-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
EP102 Dose level 1	EP102	-
EP102 Dose level 2	EP102	-
EP102 Dose level 3	EP102	-
EP102 Dose level 4	EP102	-
EP102 Dose level 5	EP102	-

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
To preliminarily evaluate the anti-tumor activity pharmacodynamic (PD) of EP102 monotherapy	Up to 21 days after administration and up until study end	Efficacy evaluations for confirmed and unconfirmed tumor responses: determined according to RECIST v1.1 criteria
To characterize the pharmacokinetic (PK) profile of EP102	Up to 21 Days after first administration	Volume of Distribution (Vd)

Trial Locations

Locations (8)

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Belgium

Masaryk Memorial Cancer Institute; 🇨🇿 Brno, Czechia

Olomouc University Hospital; 🇨🇿 Olomouc, Czechia

Netherlands Cancer Institute (NKI); 🇳🇱 Amsterdam, Netherlands

Hospital Universitari Vall d'Hebron - Vall d'Hebron Institute of Oncology; 🇪🇸 Barcelona, Spain

START Madrid - CIOCC; 🇪🇸 Madrid, Spain

Hospital Universitario de Santiago de Compostela; 🇪🇸 Santiago de Compostela, Spain