HER2 TKI · small molecule

neratinib

2 active trials across 4 of our biomarkers, targeting HER2. Not approved for any biomarker on marked.bio yet.

Also known as HKI-272, Nerlynx.

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

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
HER2 (ERBB2) activating mutation 2 6 Phase 2
EGFR exon 19 deletion / L858R 0 1 –
KRAS G12C 0 2 –
KRAS G12D 0 2 –

Trials

Status

2 of 8 trials shown

  1. Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers

    Recruiting Phase 2 Vanderbilt-Ingram Cancer Center Started 2024Primary completion 2030-04 NCT05919108

    neratinib

    …ening, histologically confirmed cancers in patients with previously documented activating HER2 mutation (see Appendix A) confirmed by a Clinical Laboratory Improvement Amendments (CLIA)-certifi…

    HER2 (ERBB2) activating mutationAnatomic Stage I Breast Cancer, Anatomic Stage II Breast Cancer, Anatomic Stage III Breast Cancer, Invasive Breast Lobular Carcinoma

  2. Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene

    Recruiting Phase 1 National Cancer Institute (NCI) Started 2022Primary completion 2028-07 NCT05372614

    neratinibtrastuzumab deruxtecan FDA EU

    A known HER2 activating mutation

    HER2 (ERBB2) activating mutationMetastatic Malignant Solid Neoplasm, Metastatic Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8