The Phase I/II eNRGy trial: Zenocutuzumab in patients with cancers harboring NRG1 gene fusions
Our partner journal Future Oncology has recently published an overview of a Clinical Trial Protocol, which highlights the Phase I/II eNRGy trial. This multicenter trial is exploring zenocutuzumab, an investigational bispecific IgG1 antibody that inhibits NRG1-activated HER2/HER3 oncogenic signaling, in patients with cancers harboring NRG1 gene fusions.
Abstract
Neuregulin 1 (NRG1) fusions are oncogenic drivers that have been detected in non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), and other solid tumors. NRG1 fusions are rare, occurring in less than 1% of solid tumors. Patients with NRG1 fusion positive (NRG1+) cancer have limited therapeutic options. Zenocutuzumab is a novel, bispecific IgG1 antibody that targets both HER2 and HER3 proteins and inhibits NRG1 binding through a ‘Dock & Block®‘ mechanism of action. Here, we describe the rationale and design of the Phase II component of the eNRGy trial, part of the overall open-label Phase I/II, multicenter trial exploring the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity of zenocutuzumab in patients with NRG1+ NSCLC, PDAC, or other solid tumors.
Plain language summary
eNRGy: a clinical trial of zenocutuzumab for cancer caused by NRG1 gene fusions:
NRG1 gene fusions are rare mutations that cause cancer cells to grow. These fusions are found in many different types of cancer. Tumors with NRG1 gene fusions do not respond well to standard treatment options. Zenocutuzumab, or Zeno, is a treatment that is being tested to see if it can stop cancer that is growing because of NRG1 gene fusions. Here, we describe the reasoning for and design of an ongoing clinical trial (eNRGy) designed to study the efficacy (how well it works) and safety of Zeno in patients with cancer that has NRG1 gene fusions. The eNRGy trial is recruiting patients with cancer that has NRG1 gene fusions, including non-small cell lung cancer, pancreatic cancer, and others. Patients who join this trial will receive Zeno once every 2 weeks until their cancer grows. The main goal (primary end point) of this trial is to determine the percentage of patients whose tumors decrease in size by 30% or more. The eNRGy trial is currently enrolling patients.
For more information, refer to ClinicalTrials.gov (Identifier: NCT02912949), visit https://nrg1.com/, or call 1-833-NRG-1234.