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    DRUG:

    WSD0922

    i
    Other names: WSD0922, WSD 0922, WSD-0922, WSD0922-FU
    Company:
    Wayshine Biopharm
    Drug class:
    EGFR inhibitor, EGFRvIII inhibitor
    Related drugs:
    6d
    WAYWIN103: A Study to Evaluate Safety and Efficacy of WSD0922-FU Combo With Osimertinib for NSCLC (clinicaltrials.gov)
    P1/2, N=48, Recruiting, Wayshine Biopharm, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Tagrisso (osimertinib) • WSD0922
    1m
    A Phase I/II Study to Evaluate EGFR-TKIs in the Treatment of Subjects with Non-Small Cell Lung Cancer (ChiCTR2500108653)
    P1/2, N=78, Not yet recruiting, Shanghai East Hospital; Hangzhou Weiruibao Biopharm Co., LTD.
    New P1/2 trial
    |
    EGFR mutation
    |
    Tagrisso (osimertinib) • WSD0922
    2ms
    WAYWIN103: A Study to Evaluate Safety and Efficacy of WSD0922-FU Combo With Osimertinib for NSCLC (clinicaltrials.gov)
    P1/2, N=48, Not yet recruiting, Wayshine Biopharm, Inc.
    New P1/2 trial
    |
    Tagrisso (osimertinib) • WSD0922
    3ms
    A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=40, Recruiting, Wayshine Biopharm, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Tagrisso (osimertinib) • WSD0922
    3ms
    A Study to Assess the Efficacy and Safety of WSD0922-FU in Patients With EGFRm+ Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=100, Recruiting, Wayshine Biopharm, Inc. | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Jun 2026 --> Jun 2027
    Trial completion date • Trial primary completion date
    |
    WSD0922
    9ms
    A Study to Assess the Efficacy of WSD0922-FU in Patients with C797S+ Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Wayshine Biopharm, Inc.
    New P2 trial
    |
    Tagrisso (osimertinib) • WSD0922
    1year
    A Study to Assess the Efficacy and Safety of WSD0922-FU in Patients with EGFRm+ Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=100, Recruiting, Wayshine Biopharm, Inc.
    New P1/2 trial • Metastases
    |
    WSD0922
    over1year
    WSD0922-FU for the Treatment of Glioblastoma, Anaplastic Astrocytoma, or Non-small Cell Lung Cancer With Central Nervous System Metastases (clinicaltrials.gov)
    P1, N=51, Recruiting, Mayo Clinic | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    WSD0922
    2years
    Efficacy of WSD0922-Fu in osimertinib-resistant NSCLC with central nervous system (CNS) metastases – Updates from the dose escalation cohort of a first-in-human phase 1 clinical trial (MC1914) (SNO 2023)
    All patients with HGA received prior radiation and temozolomide. Furthermore, prolonged stable disease (9 cycles) was observed in a patient with EGFRvIII mutant GBM. Expansion cohorts are in progress to optimize WSD0922-Fu dose and schedule for future phase 2 development.
    Clinical • P1 data
    |
    EGFR mutation • EGFRvIII mutation
    |
    Tagrisso (osimertinib) • temozolomide • WSD0922
    over2years
    WSD-0922, a novel brain-penetrant inhibitor of epidermal growth factor receptor, promotes survival in glioblastoma mouse models. (PubMed, Neurooncol Adv)
    The present preclinical study evaluated the novel EGFR inhibitor WSD-0922. We employed flank and orthotopic patient-derived xenograft models to characterize WSD-0922 and compare its efficacy to erlotinib, a potent EGFR inhibitor that failed to provide benefit for GBM patients...WSD-0922 treatment preferentially inhibited phosphorylation of several proteins, including those associated with EGFR inhibitor resistance and cell metabolism. WSD-0922 is a highly potent inhibitor of EGFR in GBM, and warrants further evaluation in clinical studies.
    Preclinical • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    erlotinib • WSD0922 • Undisclosed EGFR inhibitor
    over2years
    WSD0922-FU for the Treatment of Glioblastoma, Anaplastic Astrocytoma, or Non-small Cell Lung Cancer With Central Nervous System Metastases (clinicaltrials.gov)
    P1, N=51, Recruiting, Mayo Clinic | N=77 --> 51
    Enrollment change
    |
    EGFR mutation • EGFR L858R • EGFR T790M • EGFR amplification • EGFR L861Q • EGFR C797S • EGFRvIII mutation • EGFR G719A • IDH wild-type
    |
    WSD0922