{"entity":{"id":"nct02912949","kind":"trial","name":"A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)","aka":["eNRGy"],"tldr":"A phase 2 trial of Zenocutuzumab in non-small-cell lung cancer and pancreatic ductal adenocarcinoma, run by Partner Therapeutics, Inc., active and no longer recruiting.","summary":"A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy) is a phase 2 interventional study registered as NCT02912949 by Partner Therapeutics, Inc., with 250 participants enrolled, started 2015-01 and due to reach its primary completion in 2026-12-31. Interventions recorded: zenocutuzumab (MCLA-128).","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02912949","url":"https://clinicaltrials.gov/study/NCT02912949"},{"label":"Schram et al., efficacy of zenocutuzumab in NRG1 fusion-positive cancer (NEJM 2025)","url":"https://doi.org/10.1056/NEJMoa2405008"},{"label":"Bizengri label (openFDA): pancreatic adenocarcinoma study section","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22BIZENGRI%22"},{"label":"eNRGy (New England Journal of Medicine 2025)","url":"https://doi.org/10.1056/NEJMoa2405008"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","pancreatic","kras-wild-type-pdac","metastatic-pdac"],"sections":[],"technologies":["bispecific-antibody"],"targets":["nrg1","her3"],"drugs":["zenocutuzumab"],"companies":["partner-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-enrgy-zenocutuzumab-nrg1-fusion-positive-cancer-nejm-2025"],"journals":[],"dependsOn":[],"notes":["Registrational phase 2 (NEJM 2025): 204 patients with 12 tumour types treated; among 158 evaluable, response 30 percent (median duration 11.1 months, 19 percent ongoing), including 29 percent in lung and 42 percent in pancreatic cancer; median progression-free survival 6.8 months; treatment-related diarrhoea 18 percent, fatigue 12 percent, nausea 11 percent, infusion reactions 14 percent, one discontinuation. FDA accelerated approval for NRG1 fusion-positive pancreatic adenocarcinoma and lung cancer 4 December 2024 (label cohort of 30 pancreatic patients); cholangiocarcinoma added 2026. One UK site (Sarah Cannon Research Institute, London).","NRG1 fusions bind HER3 and drive heterodimerisation with HER2. In this registrational phase 2 study, 204 patients with advanced NRG1 fusion-positive cancer of any type received zenocutuzumab 750 mg intravenously every two weeks. Among 158 with measurable disease enrolled at least 24 weeks before the cutoff, response occurred in 30 percent (95 percent confidence interval 23 to 37), including 27 of 93 with non-small-cell lung cancer (29 percent, 20 to 39) and 15 of 36 with pancreatic cancer (42 percent, 25 to 59), across multiple fusion partners. Adverse events were mostly grade 1 or 2: diarrhoea 18 percent, fatigue 12 percent, nausea 11 percent, infusion-related reactions 14 percent, with one discontinuation (New England Journal of Medicine 2025). The FDA granted accelerated approval on 4 December 2024. There is no NICE appraisal."],"nct":"NCT02912949","phase":"2","setting":"A Phase I/II Study of MCLA-128, a Full Length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients With Solid Tumors (eNRGy)","sponsor":"Partner Therapeutics, Inc.","result":"Objective response 30 percent across 158 evaluable NRG1 fusion-positive cancers, 42 percent (15 of 36) in pancreatic cancer; median duration of response 11.1 months; median progression-free survival 6.8 months.","started":"2015-01","startedType":"actual","yearReported":2025,"enrolled":250,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response, pancreatic cancer","unit":"%","arms":[{"name":"Zenocutuzumab 750 mg every 2 weeks","n":36,"value":42,"note":"15 of 36; 95% CI 25 to 59"}],"source":"https://doi.org/10.1056/NEJMoa2405008"},{"endpoint":"Objective response, all evaluable tumour types","primary":true,"unit":"%","arms":[{"name":"Zenocutuzumab 750 mg every 2 weeks","n":158,"value":30,"note":"95% CI 23 to 37"}],"source":"https://doi.org/10.1056/NEJMoa2405008"}]},"route":"/trials/nct02912949/","neighbours":{"cancer":[{"id":"kras-wild-type-pdac","kind":"cancer","name":"KRAS wild-type pancreatic ductal adenocarcinoma","route":"/cancers/kras-wild-type-pdac/"},{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"metastatic-pdac","kind":"cancer","name":"Metastatic pancreatic ductal adenocarcinoma","route":"/cancers/metastatic-pdac/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"technology":[{"id":"bispecific-antibody","kind":"technology","name":"Bispecific antibodies","route":"/technologies/bispecific-antibody/"}],"target":[{"id":"her3","kind":"target","name":"HER3","route":"/targets/her3/"},{"id":"nrg1","kind":"target","name":"NRG1","route":"/targets/nrg1/"}],"drug":[{"id":"zenocutuzumab","kind":"drug","name":"Zenocutuzumab","route":"/drugs/zenocutuzumab/"}],"company":[{"id":"partner-therapeutics","kind":"company","name":"Partner Therapeutics","route":"/companies/partner-therapeutics/"}],"paper":[{"id":"paper-enrgy-zenocutuzumab-nrg1-fusion-positive-cancer-nejm-2025","kind":"paper","name":"eNRGy: efficacy of zenocutuzumab in NRG1 fusion-positive cancer","route":"/key-papers/paper-enrgy-zenocutuzumab-nrg1-fusion-positive-cancer-nejm-2025/"}]}}