Study on EP0031 for Patients with Advanced RET-altered Cancers

Sponsor: Ellipses Pharma

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05443126

Provider View

This clinical trial is testing a new drug, EP0031, to see if it is safe and effective for patients with advanced cancers that have changes in the RET gene. The study aims to find the best dose and understand how well the drug works.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety, side effects, and effectiveness of a new drug called EP0031 in patients with advanced cancers that have specific changes in the RET gene. Researchers are looking to find the best dose of EP0031 and see if it can help patients whose cancer has not responded to other treatments. EP0031 is designed to target and block the RET gene changes that help cancer grow.

Description

EP0031 is a new drug being tested in a study to find the best dose for adults with advanced cancers that have changes in the RET gene. These changes can make the cancer harder to treat. Currently, there are no approved treatments specifically targeting these RET changes for patients who have not responded to first-generation treatments. EP0031 is thought to work by overcoming the resistance that some cancers have to these earlier treatments. It is a strong and selective inhibitor that targets common RET gene changes, including fusions and mutations. The study is divided into two phases: Phase I focuses on finding the safest dose, while Phase II looks at how well the drug works in shrinking tumors.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older with a confirmed diagnosis of cancer that has changes in the RET gene.
  • Must be informed about other treatment options, including approved therapies targeting RET changes.
  • Must be in good general health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must be able to understand and sign a consent form and participate in all study evaluations and procedures.

Exclusion Criteria

  • Have other major gene changes driving the cancer besides RET.
  • Have spinal cord compression or untreated brain metastases. Patients with stable brain metastases can participate.
  • Have an active infection requiring treatment with antibiotics, antifungals, or antivirals.
  • Have severe or uncontrolled medical or psychiatric conditions.
  • Have chronic kidney disease or have had a kidney transplant.
  • Have active hepatitis B or C infections.
  • Have active HIV infection, unless they have a good immune cell count and no serious infections in the past year.
  • Are taking medications that strongly affect the liver enzyme CYP3A4.
  • Have poor liver or kidney function, or inadequate blood cell counts.
  • Have heart rhythm problems or heart disease, including recent heart attack or unstable chest pain.
  • Have uncontrolled high blood pressure.
  • Have a corneal ulcer at the time of screening.

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