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A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)

Exploring Zenocutuzumab for tumors with NRG1 fusion.

Recruiting
18 years and older
All
Phase 2

This study is testing a new drug called **zenocutuzumab (MCLA-128)** for people with specific solid tumors containing an **NRG1 fusion**, a change in genes that can cause cancer. The study has two parts: the first part is done, and the second part is looking at how safe and effective the drug is for patients with certain cancers like lung and pancreatic cancer. This study is open-label, which means all participants know they're getting zenocutuzumab. The study lasts up to two years, with different stages: a **screening period** (up to 28 days), a **treatment period** (28-day cycles), and a **follow-up period** (for up to two years). Patients must meet certain health criteria to join, like having a life expectancy of at least 12 weeks and not being pregnant. They should have tumors with NRG1 fusion confirmed by special tests. Patients should have already tried standard treatments for their cancer type. The study excludes people with certain infections or other serious health issues.

  • Study duration is up to 2 years with regular monitoring.
  • Participants must have specific gene changes in tumors.
  • Patients will receive zenocutuzumab and be closely monitored.
Study details
    Solid Tumours Harboring NRG1 Fusion
    NSCLC Harboring NRG1 Fusion
    Pancreatic Cancer Harboring NRG1 Fusion
    NRG1 Fusion

NCT02912949

Merus N.V.

4 January 2025

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