EP102 Safety and Efficacy in METTL3 Modulation in Advanced Solid Tumors
NCT ID: NCT07163325
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
48 participants
INTERVENTIONAL
2025-07-24
2028-11-30
Brief Summary
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This study will inform on recommended doses for further studies, e.g. dose optimization studies and / or efficacy and safety studies.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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EP102 Dose level 1
EP102
EP102 will be administered orally
EP102 Dose level 2
EP102
EP102 will be administered orally
EP102 Dose level 3
EP102
EP102 will be administered orally
EP102 Dose level 4
EP102
EP102 will be administered orally
EP102 Dose level 5
EP102
EP102 will be administered orally
Interventions
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EP102
EP102 will be administered orally
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Epics Therapeutics
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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EP102-101
Identifier Type: -
Identifier Source: org_study_id
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