Advanced Solid Tumor (Phase 1)
Conditions
Keywords
Advanced Solid Tumors, EP102
Brief 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.
Interventions
DRUGEP102
EP102 will be administered orally
Sponsors
Epics Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study will follow a Bayesian optimal interval (BOIN) design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety and tolerability of EP102 monotherapy | Up to 21 Days after first administration | The incidence of adverse drug reactions (ADRs) and serious adverse drug reactions (SARs) during study period |
| Explore the maximum tolerated dose (MTD) and recommended doses of EP102 monotherapy for subsequent studie | Up to 21 Days after first administration | Incidence of Dose Limiting Toxicities (DLT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To characterize the pharmacokinetic (PK) profile of EP102 | Up to 21 days after first administration | Peak Plasma Concentration (Cmax) |
| To preliminarily evaluate the anti-tumor activity pharmacodynamic (PD) of EP102 monotherapy | Up to 21 days after administration and up until study end | Efficacy evaluations for confirmed and unconfirmed tumor responses: determined according to RECIST v1.1 criteria |
Countries
Belgium, Czechia, Netherlands, Spain
Contacts
CONTACTClinical Trial Liaison
Outcome results
None listed