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    DRUG:

    larotinib (Z650)

    i
    Other names: Z650
    Company:
    HEC Pharm
    Drug class:
    pan-HER inhibitor
    Related drugs:
    2ms
    Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (clinicaltrials.gov)
    P2, N=30, Recruiting, Peking Union Medical College | Initiation date: Dec 2023 --> May 2024
    Trial initiation date • Metastases
    |
    cisplatin • erlotinib • carboplatin • sorafenib • AiTan (rivoceranib) • albumin-bound paclitaxel • abiraterone acetate • bicalutamide • larotinib (Z650) • ESG401 • Entyvio (vedolizumab)
    6ms
    Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular-based Stagingcarcinoma (clinicaltrials.gov)
    P2, N=30, Recruiting, Peking Union Medical College
    New P2 trial
    |
    cisplatin • erlotinib • carboplatin • sorafenib • AiTan (rivoceranib) • albumin-bound paclitaxel • bicalutamide • larotinib (Z650) • Entyvio (vedolizumab) • SHR-A1921
    1year
    Z650 in Advanced Esophageal Squamous Cell Carcinoma With EGFR Over Expression or Gene Amplification (clinicaltrials.gov)
    P1/2, N=81, Completed, Sunshine Lake Pharma Co., Ltd. | Recruiting --> Completed | N=45 --> 81 | Trial completion date: Apr 2023 --> Dec 2022
    Trial completion • Enrollment change • Trial completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR overexpression
    |
    larotinib (Z650)
    almost2years
    Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer (clinicaltrials.gov)
    P3, N=416, Recruiting, Sunshine Lake Pharma Co., Ltd. | Trial completion date: Nov 2022 --> Nov 2023 | Trial primary completion date: Aug 2022 --> Aug 2023
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression • EGFR overexpression
    |
    irinotecan • Teysuno (gimeracil/oteracil/tegafur) • larotinib (Z650)
    2years
    Z650 in Advanced Esophageal Squamous Cell Carcinoma With EGFR Over Expression or Gene Amplification (clinicaltrials.gov)
    P1/2, N=45, Recruiting, Sunshine Lake Pharma Co., Ltd. | Active, not recruiting --> Recruiting | Trial completion date: Jun 2021 --> Apr 2023 | Trial primary completion date: Apr 2021 --> Dec 2022
    Enrollment open • Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR overexpression
    |
    larotinib (Z650)
    over2years
    Larotinib in patients with advanced and previously treated esophageal squamous cell carcinoma with epidermal growth factor receptor overexpression or amplification: an open-label, multicenter phase 1b study. (PubMed, BMC Gastroenterol)
    Larotinib demonstrated promising antitumor activity and manageable safety profiles in patients with pre-treated advanced ESCC with EGFR overexpression or amplification, especially at the dose of 350 mg, which showed better efficacy and acceptable safety. A phase 3 study is underway on 350 mg larotinib in ESCC patients with EGFR overexpression.
    Clinical • P1 data • Clinical Trial,Phase I • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR amplification • EGFR overexpression
    |
    larotinib (Z650)
    over3years
    Z650 in Advanced Esophageal Squamous Cell Carcinoma With EGFR Over Expression or Gene Amplification (clinicaltrials.gov)
    P1/2, N=45, Active, not recruiting, Sunshine Lake Pharma Co., Ltd. | Trial completion date: May 2020 --> Dec 2020 | Trial primary completion date: May 2020 --> Dec 2020
    Clinical • Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR overexpression
    |
    larotinib (Z650)
    4years
    Z650 in Advanced Esophageal Squamous Cell Carcinoma With EGFR Over Expression or Gene Amplification (clinicaltrials.gov)
    P1/2, N=45, Active, not recruiting, Sunshine Lake Pharma Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: Jan 2020 --> May 2020 | Trial primary completion date: Oct 2019 --> May 2020
    Clinical • Enrollment closed • Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR overexpression
    |
    larotinib (Z650)