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
This trial does not accept healthy volunteersQualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
EP102
DrugEP102 will be administered orally
Treatment groups
48 Participants
are divided into 5 treatment groupsGroup A: EP102 Dose level 1Experimental treatment 1 intervention
Group B: EP102 Dose level 2Experimental treatment 1 intervention
Group C: EP102 Dose level 3Experimental treatment 1 intervention
Group D: EP102 Dose level 4Experimental treatment 1 intervention
Group E: EP102 Dose level 5Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Up to 21 Days after first administration2
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
Time frame
Up to 21 Days after first administration3
Explore the maximum tolerated dose (MTD) and recommended doses of EP102 monotherapy for subsequent studie
Incidence of Dose Limiting Toxicities (DLT)
Time frame
Up to 21 Days after first administrationSecondary outcomes
1
To characterize the pharmacokinetic (PK) profile of EP102
Peak Plasma Concentration (Cmax)
Time frame
Up to 21 days after first administration2
To characterize the pharmacokinetic (PK) profile of EP102
Area under the plasma concentration versus time curve (AUC)
Time frame
Up to 21 Days after first administration3
To characterize the pharmacokinetic (PK) profile of EP102
EP102 Halflife (t1/2)
Time frame
Up to 21 Days after first administration4
To characterize the pharmacokinetic (PK) profile of EP102
Clearance (Cl)
Time frame
Up to 21 Days after first administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov