marked.bio

HER2/HER3 bispecific antibody · bispecific antibody

zenocutuzumab

1 active trials across 2 of our biomarkers, targeting HER2 x HER3. 3 active approvals for a biomarker on marked.bio.

Also known as MCLA-128, Bizengri.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
zenocutuzumab
FDA, 2024
advanced, unresectable or metastatic, NRG1 gene fusion, after prior systemic therapy FDA accelerated approval 04/12/2024. Source
Bizengri 		NRG1 fusion NSCLC Approved 2024 accelerated Not approved

eNRGy (NSCLC cohort) single-arm, 64 patients
Response 33% (22-46)Lasting 7.4 months

Trial details and side effects
Patients
NRG1 fusion-positive NSCLC after systemic therapy (NCT02912949)
Most common side effects
diarrhoea, musculoskeletal pain, fatigue, nausea, infusion-related reactions, dyspnoea, rash, constipation, vomiting, abdominal pain, oedema
Notes
FDA approval summary (2024); side effects are those in 10% or more of patients. Boxed warning: embryo-fetal toxicity.
Source
FDA approval summary
zenocutuzumab
FDA, 2026
advanced, unresectable or metastatic, NRG1 gene fusion, after prior systemic therapy FDA approval 08/05/2026; the announcement does not say whether the approval is accelerated. Source
Bizengri 		NRG1 fusion cholangiocarcinoma Approved 2026 Not approved

eNRGy (cholangiocarcinoma cohort) single-arm, 19 patients
Response 37% (16-62)Lasting responses lasted 2.8 to 12.9 months

Trial details and side effects
Patients
NRG1 fusion-positive cholangiocarcinoma after systemic therapy (NCT02912949)
Most common side effects
diarrhoea, musculoskeletal pain, fatigue, nausea, infusion-related reactions, dyspnoea, rash, constipation, vomiting, abdominal pain, oedema
Notes
FDA approval summary (2026). Side effects as listed for the drug's main approval (same label).
Source
FDA approval summary
zenocutuzumab
FDA, 2024
advanced, unresectable or metastatic, NRG1 gene fusion, after prior systemic therapy FDA accelerated approval 04/12/2024. Source
Bizengri 		NRG1 fusion pancreatic Approved 2024 accelerated Not approved

eNRGy (pancreatic cohort) single-arm, 30 patients
Response 40% (23-59)Lasting responses lasted 3.7 to 16.6 months

Trial details and side effects
Patients
NRG1 fusion-positive pancreatic adenocarcinoma after systemic therapy (NCT02912949)
Most common side effects
diarrhoea, musculoskeletal pain, fatigue, nausea, infusion-related reactions, dyspnoea, rash, constipation, vomiting, abdominal pain, oedema
Notes
FDA approval summary (2024); side effects pooled across cohorts. Most of these tumours are KRAS wild-type.
Source
FDA approval summary

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
NRG1 fusion 1 2 Phase 2
HER2-low / ultralow (IHC 1+ or 2+/ISH-) 0 1 –

Sponsors

Industry sponsors leading active biomarker-selected trials of zenocutuzumab.

  1. Partner Therapeutics 1

Trials

1 of 3 trials shown

  1. A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)

    Active, not recruiting Phase 2 Partner Therapeutics Started 2015Primary completion 2026-12 NCT02912949

    zenocutuzumab FDA

    Locally-advanced unresectable or metastatic solid tumor malignancy with documented NRG1 gene fusion, identified through molecular assays such as next generation sequencing-based assays \[DN…

    NRG1 fusionSolid Tumours Harboring NRG1 Fusion, NSCLC Harboring NRG1 Fusion, Pancreatic Cancer Harboring NRG1 Fusion, NRG1 Fusion