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

Study Identifier:
EP102-101
CT.gov Identifier:
NCT07163325
EudraCT Identifier:
202552000000
EU Trial (CTIS) Number:
2025-521305-40-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

Considering participating in a START clinical trial?

Get Started

Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: EP102 Dose level 1 Drug: EP102
    • Read More
  • Drug: Experimental: EP102 Dose level 2 Drug: EP102
  • Drug: Experimental: EP102 Dose level 3 Drug: EP102
  • Drug: Experimental: EP102 Dose level 4 Drug: EP102
  • Drug: Experimental: EP102 Dose level 5 Drug: EP102
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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.

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Emiliano Calvo
    Status
    Recruitment on Hold
    Condition(s) Treated at Site
    Solid Tumor