Study on Lurbinectedin for Treating FET-Fused Tumors

Sponsor: Children's Hospital of Philadelphia

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05918640

Provider View

This clinical trial is testing the safety and effectiveness of a drug called lurbinectedin for treating people with recurring or returning solid tumors, including Ewing sarcoma.

Patient Parameters

Program Overview

The aim of this study is to see if lurbinectedin, a drug, can safely and effectively treat solid tumors that have come back or not responded to previous treatments. This includes tumors like Ewing sarcoma, which are driven by specific genetic changes. Researchers want to find out if lurbinectedin can target these changes and help reduce the tumors.

Description

This study is exploring the use of lurbinectedin as a targeted treatment for tumors with specific genetic changes known as FET fusions. These include changes in genes like EWSR1, FUS, and TAF15, which are involved in certain cancers such as Ewing sarcoma. Lurbinectedin has shown promise in lab tests by blocking these genetic changes, which may help shrink tumors. The study will test if lurbinectedin can effectively target these changes in patients and improve their condition.

Eligibility Criteria

Inclusion Criteria

  • Must be 10 years or older.
  • Have a confirmed diagnosis of a solid tumor that has returned or not responded to initial treatment, with specific genetic changes (FET fusion) confirmed by lab tests.
  • For Phase 1: Must have at least one measurable tumor or a tumor that can be evaluated by scans.
  • For Phase 2: Must have a confirmed diagnosis of Ewing sarcoma with specific genetic changes.
  • Must meet certain health requirements, including:
    • Liver function within specified limits.
    • Kidney function within specified limits.
    • Bone marrow function within specified limits.
    • Heart function within specified limits.
  • Must provide written informed consent.
  • Must agree to use effective birth control during the study and for a specified time after.
  • Must be willing to undergo a tumor biopsy if 18 years or older.
  • Must have recovered from previous treatments to a certain level.
  • Must have waited a specified time after previous treatments before starting the study.

Exclusion Criteria

  • Have had previous treatment with trabectedin or lurbinectedin.
  • Have known brain metastases.
  • Have a known bleeding disorder.
  • Are pregnant or breastfeeding.
  • Are currently receiving another investigational drug or anticancer treatment.
  • Are taking supplements or medications that could affect the liver or interact with the study drug.
  • Have a significant unrelated illness or uncontrolled infection.
  • Are unable to comply with study requirements or safety monitoring.
  • Have active viral hepatitis (Hepatitis A, B, or C).

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