| 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. © 2024 The Authors. |
| Keywords: |
protein kinase b; adult; cancer chemotherapy; middle aged; gene mutation; genetics; clinical trial; solid tumor; pancreas cancer; endometrium cancer; neoplasm; neoplasms; colorectal cancer; cell proliferation; metabolism; cell survival; pharmacodynamics; phase 2 clinical trial; breast cancer; gene amplification; gene expression; carcinoma, non-small-cell lung; lung neoplasms; epidermal growth factor receptor 2; carcinoma, pancreatic ductal; lung cancer; dexamethasone; antineoplastic activity; cytotoxicity; pathology; monoclonal antibody; lung tumor; immunotherapy; screening; paracetamol; multicenter study; immunogenicity; gene fusion; oncogene proteins, fusion; ovary carcinoma; receptor, erbb-2; phase 1 clinical trial; immunoglobulin g1; drug therapy; epidermal growth factor receptor 3; her2; non small cell lung cancer; nsclc; neu differentiation factor; neuregulin-1; pancreatic ductal carcinoma; receptor, erbb-3; antibodies, monoclonal, humanized; high throughput sequencing; afatinib; estimated glomerular filtration rate; her3; humans; human; male; female; article; rna sequencing; seribantumab; immunological antineoplastic agent; antineoplastic agents, immunological; alanine aminotransferase level; aspartate aminotransferase level; pdac; nrg1 fusion; zenocutuzumab; nrg1 protein, human; dexchlorpheniramine; oncogene fusion protein; enrgy trial; nrg1+; recruiting; zeno
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