Early Access Program for HER2/HER3 Bispecific Antibody MCLA-128 for Patients with Advanced NRG1-Fusion Positive Solid Tumors

Sponsor: Merus N.V.

Expanded Access
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04100694

Provider View

This program offers access to the experimental drug MCLA-128 for patients with advanced solid tumors that have a specific genetic feature called NRG1 fusion. It is for those who cannot join a current clinical trial for this drug.

Patient Parameters

Program Overview

Merus is offering an early access program for patients with advanced solid tumors that have a specific genetic change known as NRG1 fusion. This program provides the drug MCLA-128 to patients who cannot participate in ongoing clinical trials for this treatment. Doctors will evaluate if the potential benefits of the drug outweigh the risks based on each patient's medical history and eligibility. New sites will be added to the program as they apply and are approved. Patients must meet certain criteria to be eligible.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have at least one tumor that can be measured by scans.
  • Have an advanced solid tumor with a confirmed NRG1 fusion, identified through specific lab tests.
  • Must have stopped other cancer treatments for a certain period before starting MCLA-128.
  • Be in good general health with an ECOG performance status of 0 to 2.
  • Have normal organ function at the start of treatment.
  • Women of childbearing age must have a negative pregnancy test.
  • Must be able to provide written consent to participate.
  • Not eligible for any other clinical trials.
  • No conditions that would prevent the safe use of the investigational drug.

Exclusion Criteria

  • Have untreated or symptomatic brain lesions.
  • Have an active, uncontrolled infection.
  • Have cancer that has spread to the brain's lining.
  • Have allergies to MCLA-128 or similar drugs.
  • Have significant heart problems or a low heart function.
  • Have any medical or psychological conditions that would interfere with participation or understanding of the study.

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