Study on Zenocutuzumab (MCLA-128) for Patients with Solid Tumors with NRG1 Fusion

Sponsor: Merus N.V.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT02912949

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, Zenocutuzumab (MCLA-128), in patients with solid tumors that have a specific genetic change called NRG1 fusion. The study aims to find out how well the drug works and how the body responds to it.

Patient Parameters

Program Overview

This study is exploring a new treatment called Zenocutuzumab (MCLA-128) for patients with solid tumors that have a genetic change known as NRG1 fusion. The trial is being conducted in multiple locations and involves two main parts. The first part, which is already completed, focused on finding the right dose. The second part is looking at how safe and effective the drug is in different groups of patients, including those with lung cancer, pancreatic cancer, and other solid tumors with NRG1 fusion. Participants will go through a screening period, receive treatment in 28-day cycles, and have follow-up visits to monitor their health and the treatment's effects.

Description

This study is divided into two parts. The first part, which is completed, was about finding the right dose of Zenocutuzumab (MCLA-128). The second part is testing the drug in new groups of patients:

  • Group F: Patients with non-small cell lung cancer (NSCLC) with NRG1 fusion.
  • Group G: Patients with pancreatic cancer with NRG1 fusion.
  • Group H: Patients with other solid tumors with NRG1 fusion.

The study will look at how safe the drug is and how well it works in these patients. It will measure how many patients have a complete or partial response to the treatment or have stable disease for at least 24 weeks. The study includes a screening period, treatment cycles of 28 days, and follow-up visits for up to two years to check on participants' health and survival.

Eligibility Criteria

Inclusion Criteria

  • Have at least one tumor that can be measured by scans or tests.
  • Be in good overall health with a performance status score of 0 to 2.
  • Have a life expectancy of at least 12 weeks.
  • Have recovered from any side effects of previous cancer treatments to a mild level.
  • Have not received any cancer treatment or investigational drugs within a certain time before starting the study.
  • Have recovered from major surgery or complications to a mild level.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Be able to provide a tumor sample for analysis.
  • Not be pregnant or nursing, and agree to use effective birth control during and for six months after the study.
  • Have received standard treatment for their cancer type or have no other satisfactory treatment options.
  • Have a solid tumor with NRG1 fusion identified through specific genetic tests.

Exclusion Criteria

  • Be pregnant or breastfeeding.
  • Have an active, uncontrolled infection or unexplained fever.
  • Be allergic to any components of Zenocutuzumab (MCLA-128).
  • Have known HIV, active Hepatitis B without treatment, or Hepatitis C unless treated and with undetectable viral loads.
  • Have unstable or symptomatic brain metastases.
  • Have cancer spread to the membranes around the brain and spinal cord.
  • Have a heart function below 50% or significant heart disease.
  • Have another cancer unless treated with curative intent over two years ago.
  • Have any medical or psychological condition that may interfere with participation in the study.

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