marked.bio

HER2 TKI · small molecule

pyrotinib

6 active trials across 11 of our biomarkers, targeting HER2. Not approved for any biomarker on marked.bio yet.

Also known as SHR-1258.

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-low / ultralow (IHC 1+ or 2+/ISH-) 3 4 Phase 3
ALK fusion 2 3 Phase 2
BRAF V600E 2 2 Phase 2
ROS1 fusion 2 2 Phase 2
BRCA1/2 mutation 1 1 Phase 2
EGFR exon 19 deletion / L858R 1 1 Phase 2
EGFR exon 20 insertion 1 1 Phase 2
HER2 (ERBB2) activating mutation 1 7 Phase 1/2
KRAS G12C 1 1 Phase 2
NTRK1/2/3 fusion 1 1 Phase 2
RET fusion or mutation 1 1 Phase 2

Sponsors

Industry sponsors leading active biomarker-selected trials of pyrotinib.

  1. RemeGen 1

Trials

6 of 14 trials shown

  1. Neoadjuvant Pyrotinib in HR-positive and HER2-low High-risk Early Breast Cancer

    Active, not recruiting Phase 3 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Started 2024Primary completion 2026-07 NCT06144944

    pyrotinibdoxorubicincyclophosphamidepaclitaxel

    …eceptor-positve ( estrogen receptor and/or progesterone receptor ≥ 10% stained cells) and HER2-low (immunochemistry 2+ with fluorescent in situ hybridization negative)

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Breast Cancer Invasive, Hormone-receptor-positive Breast Cancer, HER2 Low Breast Carcinoma, Early-stage Breast Cancer

  2. A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation

    Not yet recruiting Phase 1/2 RemeGen Starts 2027Primary completion 2027-12 NCT05745740

    disitamab vedotinpyrotinib

    Documented HER2 exon 20 insertion mutation.

    HER2 (ERBB2) activating mutationNon-small Cell Lung Cancer

  3. Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.

    Recruiting Phase 2 Sun Yat-sen University Started 2024Primary completion 2027-11 NCT06563999

    sunvozertinib FDAcrizotinibpralsetiniblarotrectinibsavolitinibpyrotinibdabrafenibtrametinibglecirasibensartinib

    Subjects should have a rare mutation based on NGS, including mutations of EGFR exon20ins, ROS1 fusion, RET fusion, NTRK fusion, MET 14 exon, HER2, BRAF V600E, KRAS G12C, and ALK …

    EGFR exon 20 insertionKRAS G12CBRAF V600EALK fusionROS1 fusionRET fusion or mutationNTRK1/2/3 fusionLung Cancer Stage III, Mutation

  4. Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases

    Recruiting Phase 2 Henan Cancer Hospital Started 2023Primary completion 2028-12 NCT05769010

    trastuzumab rezetecanpyrotinibbevacizumabAdebelizumab

    Pathologically confirmed HER2-positive or HER2-low advanced breast cancer;

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Metastatic Breast Cancer

  5. Phase II Neoadjuvant Pyrotinib Combined With Neoadjuvant Chemotherapy in HER2-low-expressing and HR Positive Early or Locally Advanced Breast Cancer: a Single-arm, Non-randomized, Single-center, Open Label Trial

    Active, not recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Started 2021Primary completion 2023-09 NCT05165225

    pyrotinibcyclophosphamidedocetaxel

    HER2-low-positive (defined here as HER2 IHC 2+ and FISH-) and HR positive(defined here as ER and/o…

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Breast Cancer, HER2-low-expressing Breast Cancer, Hormone Receptor-positive Breast Cancer, Neoadjuvant Therapy

  6. PLATFORM Study of Precision Medicine for Rare Tumors

    Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2020Primary completion 2026-07 NCT04423185

    aumolertinibdacomitinib FDA EUalectinibcrizotinibpyrotinibimatinibniraparibpalbociclibvemurafenibsintilimabatezolizumab

    when obtaining EGFR mutation, ALK fusion, ROS-1 fusion, C-MET amplification, C-MET mutation, BRAF mutation, BRCA1/2 mu…

    EGFR exon 19 deletion / L858RBRAF V600EBRCA1/2 mutationALK fusionROS1 fusionRare Tumor