EP102 Safety and Efficacy in METTL3 Modulation in Advanced Solid Tumors

NCT07163325 | Recruiting Phase 1 DMC

• 1 other identifier: EP102-101
• Study Type: interventional
• Target: 48
• Locations: 4 countries
• Sites: 8

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.

Conditions

Advanced Solid Tumor (Phase 1)

Keywords

Advanced Solid Tumors; EP102

Outcome Measures

Primary Outcomes (3)

• To assess the safety and tolerability of EP102 monotherapy

  The incidence of adverse drug reactions (ADRs) and serious adverse drug reactions (SARs) during study period

  Up to 21 Days after first administration

• To assess the safety and tolerability of EP102 monotherapy

  The incidence of all treatment-emergent AEs and treatment-emergent serious adverse events (SAEs) during study period

  Up to 21 Days after first administration

• Explore the maximum tolerated dose (MTD) and recommended doses of EP102 monotherapy for subsequent studie

  Incidence of Dose Limiting Toxicities (DLT)

  Up to 21 Days after first administration

Secondary Outcomes (6)

• To characterize the pharmacokinetic (PK) profile of EP102

  Up to 21 days after first administration

• To characterize the pharmacokinetic (PK) profile of EP102

  Up to 21 Days after first administration

• To characterize the pharmacokinetic (PK) profile of EP102

  Up to 21 Days after first administration

• To characterize the pharmacokinetic (PK) profile of EP102

  Up to 21 Days after first administration

• To characterize the pharmacokinetic (PK) profile of EP102

  Up to 21 Days after first administration

Study Arms (5)

EP102 Dose level 1

EXPERIMENTAL

Drug: EP102

EP102 Dose level 2

EXPERIMENTAL

Drug: EP102

EP102 Dose level 3

EXPERIMENTAL

Drug: EP102

EP102 Dose level 4

EXPERIMENTAL

Drug: EP102

EP102 Dose level 5

EXPERIMENTAL

Drug: EP102

Interventions

EP102 DRUG

EP102 will be administered orally

EP102 Dose level 1; EP102 Dose level 2; EP102 Dose level 3; EP102 Dose level 4; EP102 Dose level 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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.

Sponsors & Collaborators

• Epics Therapeutics: lead

Study Sites (8)

Institut Jules Bordet

Brussels, 1070, Belgium

RECRUITING

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

Masaryk Memorial Cancer Institute

Brno, 656 53, Czechia

RECRUITING

Olomouc University Hospital

Olomouc, 77900, Czechia

RECRUITING

Netherlands Cancer Institute (NKI)

Amsterdam, 1066 CX, Netherlands

RECRUITING

Hospital Universitari Vall d'Hebron - Vall d'Hebron Institute of Oncology

Barcelona, 8035, Spain

RECRUITING

START Madrid - CIOCC

Madrid, 28050, Spain

RECRUITING

Hospital Universitario de Santiago de Compostela

Santiago de Compostela, 15706, Spain

RECRUITING

Related Publications (1)

• Dutheuil G, Oukoloff K, Korac J, Lenoir F, El Bousmaqui M, Probst N, Lapin A, Nakhabina G, Sorlet C, Parmentier N, Karila D, Ghavtadze N, Casault P, Claridge S, Sapmaz S, Slater MJ, Fraser GL. Discovery, Optimization, and Preclinical Pharmacology of EP652, a METTL3 Inhibitor with Efficacy in Liquid and Solid Tumor Models. J Med Chem. 2025 Feb 13;68(3):2981-3003. doi: 10.1021/acs.jmedchem.4c02225. Epub 2025 Jan 30.

  PMID: 39883878 BACKGROUND

Central Study Contacts

Clinical Trial Liaison

CONTACT

+32 71 348 500; info@epicstx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will follow a Bayesian optimal interval (BOIN) design.

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: September 9, 2025
• Study Start: July 24, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: September 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The sponsor will establish when the IPD will be shared after the analysis of the study results
• Access Criteria: The sponsor will establish the IPD access criteria after the analysis of the study results

Locations

CZ (2); NL (1); BE (2); ES (3)