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    DRUG:

    larotinib (Z650)

    i
    Other names: Z650
    Company:
    HEC Pharm
    Drug class:
    pan-HER inhibitor
    Related drugs:
    7ms
    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 2023 --> Dec 2026 | Trial primary completion date: Aug 2023 --> Aug 2026
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression
    |
    irinotecan • Teysuno (gimeracil/oteracil/tegafur) • larotinib (Z650)
    7ms
    A Study to Evaluate Drug-Drug Interaction of Larotinib With Itraconazole and Rifampin in Healthy Adult Participants (clinicaltrials.gov)
    P1, N=32, Completed, Sunshine Lake Pharma Co., Ltd. | Active, not recruiting --> Completed
    Trial completion
    |
    itraconazole • larotinib (Z650) • rifampicin
    7ms
    Pharmacokinetics Study of Larotinib in Subjects With Impaired Hepatic Function (clinicaltrials.gov)
    P1, N=32, Not yet recruiting, Sunshine Lake Pharma Co., Ltd. | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    larotinib (Z650)
    11ms
    Molecular Subtyping and Genomic Profiling Expand Precision Medicine in KRAS Wild-Type Pancreatic Cancer. (PubMed, Cancer Sci)
    Kinase fusions (NTRK and RET) were linked to response to larotinib and RET-specific inhibitors, respectively. KRAS-WT PDAC contains actionable mutations and fusions, offering significant potential for targeted and immune-based therapies. Further clinical studies are needed to validate these therapeutic approaches.
    Journal • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • HRD (Homologous Recombination Deficiency) • ARID1A (AT-rich interaction domain 1A) • CCDC6 (Coiled-Coil Domain Containing 6) • ETV6 (ETS Variant Transcription Factor 6) • KMT2C (Lysine Methyltransferase 2C) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • PIK3CA mutation • HRD • ATM mutation • ARID1A mutation • KRAS wild-type • RAS wild-type • ROS1 fusion
    |
    larotinib (Z650)
    over1year
    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) • OQY-3258 • Entyvio (vedolizumab)
    2years
    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) • tizetatug rezetecan (SHR-A1921)
    over2years
    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)
    over3years
    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)
    over3years
    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)
    4years
    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)
    5years
    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)
    over5years
    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)