EP102 to target METTL3 in advanced solid tumors
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
This will test EP102, a drug that targets METTL3, in adults with advanced solid tumors who have no standard treatment options or whose cancer progressed after prior therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Epics Therapeutics Industry-sponsored |
| Locations | 8 sites (Brussels and 7 other locations) |
| Trial ID | NCT07163325 on ClinicalTrials.gov |
What this trial studies
This first-in-human, Phase 1 dose-escalation trial gives EP102 to adults with a variety of advanced solid tumors to define the maximum tolerated dose and overall safety profile. The study collects pharmacokinetic (PK) and pharmacodynamic (PD) measurements and enrolls patients with measurable disease who have exhausted or have no standard treatments. Investigators will also perform an exploratory evaluation of antitumor activity using RECIST v1.1 criteria. Results will inform recommended doses for subsequent dose-optimization and efficacy studies.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed locally advanced or metastatic solid tumors of the listed cancer types who have at least one measurable lesion per RECIST v1.1 and have received at least one prior line of systemic therapy or have no available standard treatment.
Not a fit: Patients with cancers not listed, without measurable disease, who still have effective standard treatment options, or who cannot tolerate risks of a first-in-human dose-escalation study are unlikely to benefit.
Why it matters
Potential benefit: If successful, EP102 could offer a new treatment option for patients with advanced solid tumors driven by METTL3-related biology.
How similar studies have performed: Modulating METTL3 is a novel therapeutic approach with encouraging preclinical data but limited prior clinical evidence, and EP102 represents a first-in-human test of this mechanism.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Brussels and 7 other locations
- Institut Jules Bordet — Brussels, Belgium (Recruiting)
- Cliniques universitaires Saint-Luc — Brussels, Belgium (Recruiting)
- Masaryk Memorial Cancer Institute — Brno, Czechia (Recruiting)
- Olomouc University Hospital — Olomouc, Czechia (Recruiting)
- Netherlands Cancer Institute (NKI) — Amsterdam, Netherlands (Recruiting)
- Hospital Universitari Vall d'Hebron - Vall d'Hebron Institute of Oncology — Barcelona, Spain (Recruiting)
- START Madrid - CIOCC — Madrid, Spain (Recruiting)
- Hospital Universitario de Santiago de Compostela — Santiago de Compostela, Spain (Recruiting)
Study contacts
- Study coordinator: Clinical Trial Liaison
- Email: info@epicstx.com
- Phone: +32 71 348 500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.