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Gene fusion in NRG1

NRG1 fusion

Active trials
6
Recruiting now
3
FDA approvals
3
EU approvals
0
Companies
4

Trials that select patients by NRG1 fusion, the therapies approved for it, and who is developing what. Seen most often in NSCLC, pancreatic.

Added in v3.0. Matches on this page are included in our accuracy checks (about 9 in 10 correct across all pages) but have had fewer checks than the original pages. Every trial shows the words that matched.

Trials as of 2026-10-27. No new trials, status changes or approvals since 2026-10-20. Earlier weeks. Follow this page. .

Active trials by phase
Phase 1: 3 active trials13Phase 1/2: 1 active trials1/21Phase 2: 2 active trials22
Trials started per year (2026 so far)
2010: 0 trials started20102011: 0 trials started2012: 0 trials started2013: 0 trials started2014: 0 trials started2015: 1 trials started20152016: 0 trials started2017: 0 trials started2018: 0 trials started2019: 1 trials started2020: 1 trials started20202021: 3 trials started32022: 2 trials started2023: 1 trials started2024: 2 trials started2025: 1 trials started2026: 0 trials started2026

Approved therapies

Approvals in the United States (FDA) and the European Union (EMA), one row per drug, regimen and tumour type. Where we have them, the pivotal trial's results and side effects are shown under each therapy, from the official label. Results from different trials are not directly comparable: patients, earlier treatments and comparators differ.

Results side by side

The pivotal trials behind the approvals below, on one scale. Trials differ in patients, earlier treatment and comparator, so this is a map of the evidence, not a ranking.

Response rates Share of patients whose tumours shrank by at least 30%, with 95% confidence interval where reported.
NSCLC
zenocutuzumab eNRGy (NSCLC cohort) 33%
cholangiocarcinoma
zenocutuzumab eNRGy (cholangiocarcinoma cohort) 37%
pancreatic
zenocutuzumab eNRGy (pancreatic cohort) 40%
TherapyTumourUnited StatesEuropean Union
zenocutuzumab
FDA, 2024
advanced, unresectable or metastatic, NRG1 gene fusion, after prior systemic therapy FDA accelerated approval 04/12/2024. Source
Bizengrizenocutuzumab page 		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
Bizengrizenocutuzumab page 		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
Bizengrizenocutuzumab page 		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

Drugs in active trials

Targeted drugs, antibody-drug conjugates and immunotherapies in active trials on this page, approved ones first, then by the furthest phase reached. Chemotherapy and supportive medicines are left out. "Not yet classified" means an early drug known only by its code.

6 of 6 drugs shown

DrugTypeActive trialsFurthest phaseLead sponsors
zenocutuzumab FDAHER2 x HER3 HER2/HER3 bispecific antibody 1 Phase 2 Partner Therapeutics
HMBD-001HER3 anti-HER3 antibody 2 Phase 1/2 Hummingbird Bioscience
enzalutamideandrogen receptor androgen receptor inhibitor 1 Phase 1/2 Academic only
patritumab deruxtecanHER3 HER3 ADC 1 Phase 2 Academic only
CGT4255 Not yet classified 1 Phase 1 Cogent Biosciences
SYS6023 Not yet classified 1 Phase 1 CSPC

Upcoming readouts

Active phase 2 and 3 trials whose primary completion date falls in the next 12 months: the date the main results are due to be collected, according to the sponsor. Results are usually published months later, and these dates often slip.

DueTrialPhaseDrugsSponsor
2026-12 A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)NCT02912949 · 250 patients Phase 2 zenocutuzumab Partner Therapeutics
2027-04 Patritumab Deruxtecan in Patients With Solid Tumor Harboring an NRG1 FusionNCT06383884 · 30 patients Phase 2 patritumab deruxtecan Samsung Medical Center

Companies

Industry sponsors leading active trials, by number of trials. Each square is one trial, shaded by phase.

  1. Partner Therapeutics 1
  2. CSPC 1
  3. Cogent Biosciences 1
  4. Hummingbird Bioscience 1

Trials

Matched automatically from registry text, so a few trials may only mention NRG1 fusion rather than require it. Check the quoted criterion, and the registry entry before relying on a match.

6 of 12 trials shown

  1. Patritumab Deruxtecan in Patients With Solid Tumor Harboring an NRG1 Fusion

    Recruiting Phase 2 Samsung Medical Center Started 2024Primary completion 2027-04 NCT06383884

    patritumab deruxtecan

    Documentation of NRG1 fusion detected from tumor tissue or blood sample, including but not limited to TruSightOncology…

    Solid Tumor, Adult

  2. A Phase I/IIa Trial of HMBD-001 in Advanced HER3 Positive Solid Tumours

    Active, not recruiting Phase 1/2 Cancer Research UK Started 2021Primary completion 2025-11 NCT05057013

    HMBD-001enzalutamide

    Participants with a confirmed existing NRG1 fusion rearrangement or HER amplification will also be considered eligible.

    Bladder Cancer, Triple Negative Breast Cancer, Castration-resistant Prostate Cancer, Cervical Cancer

  3. 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…

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

  4. A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors

    Recruiting Phase 1 Cogent Biosciences Started 2025Primary completion 2028-05 NCT07361562

    CGT4255

    …etastatic, and/or unresectable solid tumor with documented ERBB2-activating alteration or NRG1 gene fusion in blood and/or tumor or HER2 overexpression in tumor

    Advanced Solid Tumor, Adult, ERBB2 Altered Breast Cancer, ERBB2 Gene Amplification, HER2 Overexpression

  5. A Clinical Study of SYS6023 in Patients With Advanced Solid Tumors

    Recruiting Phase 1 CSPC Started 2024Primary completion 2026-10 NCT07110883

    SYS6023

    …NSCLC, prostate cancer, etc.) which may potentially benefit from this treatment, or known NRG1 fusion tumors, both of which have previously treated with at least one line of systemic therapy.

    Advanced Solid Tumor

  6. Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation

    Active, not recruiting Phase 1 Hummingbird Bioscience Started 2023Primary completion 2031-03 NCT05919537

    HMBD-001docetaxelnab-paclitaxelgemcitabine

    Arms A, B and C: Cancer harboring an NRG1 gene fusion with EGF-like domain

    Non-Small Cell Lung Cancer, Pancreatic Cancer, Locally Advanced Solid Tumor, Metastatic Solid Tumor