EP102 to target METTL3 in advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Institut Jules Bordet
  Brussels, Belgium Recruiting
• Cliniques universitaires Saint-Luc
  Brussels, Belgium Recruiting
• Universitair Ziekenhuis Gent (UZ Gent) - Drug Research Unit Gent (DRUG)
  Ghent, Belgium Recruiting
• Leuven Cancer Institute (LKI)
  Leuven, Belgium Recruiting
• Masaryk Memorial Cancer Institute
  Brno, Czechia Recruiting
• Olomouc University Hospital
  Olomouc, Czechia Recruiting

Study contacts

• Study coordinator: Clinical Trial Liaison
• Email: info@epicstx.com
• Phone: +32 71 348 500

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• APX-343A alone or with pembrolizumab for advanced solid tumors

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.