EP102 Safety and Efficacy in METTL3 Modulation in Advanced Solid Tumors

ConditionAdvanced Solid Tumor (Phase 1)

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorEpics Therapeutics

About this trial

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.

Eligibility criteria

Qualifiers

ovarian cancer

cervical cancer

endometrial cancer

testicular cancer

Disqualifiers

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.