Clinical trial · Interventional
EP102 Safety and Efficacy in METTL3 Modulation in Advanced Solid Tumors
A Phase 1 Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered EP102 Monotherapy in Participants With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor (Phase 1) | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EP102 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- EP102 Dose level 1
- interventionNames
- Drug: EP102
- type
- EXPERIMENTAL
- label
- EP102 Dose level 2
- interventionNames
- Drug: EP102
- type
- EXPERIMENTAL
- label
- EP102 Dose level 3
- interventionNames
- Drug: EP102
- type
- EXPERIMENTAL
- label
- EP102 Dose level 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDDutheuil 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
- DERIVEDAbbad L, Chatziantoniou C. Discovering New Therapies for Kidney Fibrosis: The Promise of Epigenetic and Epitranscriptomic Modulation. J Am Soc Nephrol. 2026 Jul 1;37(7):1367-1369. doi: 10.1681/ASN.0000001136. Epub 2026 May 28. No abstract available. PMID 42210870