Clinical trials are ongoing for cancer patients who have solid tumors that have a specific genetic abnormality called an NRG1 Fusion.
eNRGy Clinical Trial for Zenocutuzumab (MCLA-128)

If you are a patient with a solid tumor with an NRG1 fusion or a physician treating a patient with NRG1 fusion positive cancer, please call 1-833-NRG-1234 for more information about zenocutuzumab (MCLA-128) and the MCLA-128-CL01 clinical trial.

A Phase 1/2 clinical trial is ongoing for zenocutuzumab (MCLA-128), an experimental cancer medicine, being studied in cancer patients who have solid tumors that have an NRG1 Fusion.

Zenocutuzumab (MCLA-128) is an intravenous (IV) medication that is given through a tube infused in a vein in a patient’s arm every 2 weeks, administering an infusion that typically lasts from 2-4 hours. At this time, there is no approved therapy for the specific treatment of NRG1 Fusion-positive solid tumors.

Global Clinical Trial Locations

For the eNRGy study of zenocutuzumab (MCLA-128) in cancer patients with NRG1 Fusions, there are more than 60 medical centers around the world that are enrolling patients. The map below provides details about clinical trial locations for the eNRGy study.

For patients with cancer harboring NRG1 fusions that are otherwise unable to participate in an applicable clinical trial, they may be eligible to participate in the Early Access program for zenocutuzumab (MCLA-128).

eNRGy Clinical Trial Facts

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

ClinicialTrials.gov
clinicaltrials.gov/ct2/show/NCT02912949

Abbreviated Eligibility Requirements

  • Be 18 years or older
  • Have a solid tumor harboring the NRG1
    gene fusion
  • All genders

Trial Locations
Asia, Europe, United States, Canada and Israel

Indications

  • Pancreatic cancer harboring NRG1
    fusion
  • Non-small cell lung cancer harboring
    NRG1 fusion
  • Solid tumors harboring NRG1 fusion

Trial Purpose
To assess the magnitude of anti-tumor
activity of zenocutuzumab (MCLA-128) in patients with
NRG1 fusion. (Overall Response Rate)

Participation Questions
1-833-NRG-1234

Identifier Number(s)
MCLA-128-CL01
2014-003277-42 (EudraCT #)

NCT#
NCT02912949
NCT04100694

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Jonna S, Feldman RA, Swensen J, et al. http://clincancerres.aacrjournals.org/content/early/2019/04/13/1078-0432.CCR-19-0160 Detection of NRG1 gene fusions in solid tumors [published online April 15, 2019]. Clin Cancer Res. doi: 10.1158/1078-0432.CCR-19-0160
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Definition of a clinical trial:
Clinical trials in cancer are research studies where people volunteer to receive experimental medications to see if they are safe and effective in treating their type of cancer. Information is collected to determine how the medication works and how the patient feels while taking the medication. The information collected on all patients is combined at the end of the study and if the medication is shown to be safe and effective, it could result in the medication being approved for treatment of patients with that type of cancer. For more information about clinical trials, please visit U.S. National Institutes of Health, National Library of Medicine – ClinicalTrials.gov
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Definition of Early Access:
A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called expanded access or compassionate use. There are different early access types. For more information generally, see FDA Expanded Access: Information for Patients. And for more information regarding early/expanded access related to MCLA-128 and NRG1 fusion, see https://clinicaltrials.gov/ct2/show/NCT04100694?cond=NRG1+fusion&rank=1
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