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    DRUG:

    utidelone IV (UTD1)

    i
    Other names: UTD1, UTD-1
    Associations

    News

    Trials
    Company:
    Beijing Biostar Technologies, Luye Group
    Drug class:
    Microtubule inhibitor, Tubulin polymerization promoter
    Related drugs:
    Associations

    News

    Trials
    6ms
    The Efficacy and Safety of Utidelone Plus Tirelizumab and Bevacizumab for Advanced or Metastatic Triple-negative Breast Cancer (UTILIZABLE) ：Single-arm, Prospective, Open Clinical Study (clinicaltrials.gov)
    P2, N=78, Recruiting, Huihua Xiong
    New P2 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 expression • ER expression
    |
    Avastin (bevacizumab) • Tevimbra (tislelizumab) • utidelone IV (UTD1)
    6ms
    Utidelone Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=612, Recruiting, Beijing Biostar Pharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting | Initiation date: Jan 2023 --> May 2023
    Enrollment open • Trial initiation date • Metastases
    |
    ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • ALK positive • EGFR T790M • ALK fusion • EGFR positive
    |
    docetaxel • utidelone IV (UTD1)
    6ms
    Utidelone in Combination With AC Versus Docetaxel in Combination With AC for Neoadjuvant Chemotherapy in Patients With HER2-negative Breast Cancer (clinicaltrials.gov)
    P3, N=552, Recruiting, Beijing Biostar Pharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting | Initiation date: Jan 2023 --> May 2023
    Enrollment open • Trial initiation date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    docetaxel • doxorubicin hydrochloride • cyclophosphamide • utidelone IV (UTD1)
    8ms
    Exploratory Study of Advanced Breast Cancer in HER2 Positive Patients With Failure of Multi-line Therapy Treated by Combination of Inetetamab (Cipterbin) + PD-1 Inhibitor Combined With Utidelone. (clinicaltrials.gov)
    P2, N=46, Active, not recruiting, Henan Cancer Hospital | Recruiting --> Active, not recruiting | Trial completion date: Oct 2022 --> Dec 2024
    Enrollment closed • Trial completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification
    |
    gemcitabine • capecitabine • albumin-bound paclitaxel • vinorelbine tartrate • Cipterbin (inetetamab) • utidelone IV (UTD1)
    9ms
    Study of Utidelone Based Neoadjuvant Treatment on Early High-risk or Locally Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=181, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    New P2 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    Herceptin (trastuzumab) • carboplatin • Perjeta (pertuzumab) • epirubicin • utidelone IV (UTD1)
    10ms
    Preliminary results from a prospective study of inetetamab in combination with pyrotinib and utidelone for HER2-positive metastatic breast cancer (IPUtrial) (ESMO 2023)
    Conclusions Inetetamab plus pyrotinib and utidelone may be an excellent scheme for HER2-positive metastatic breast cancer. This trial is still ongoing and needs long-term follow-up.
    Clinical • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Irene (pyrotinib) • Cipterbin (inetetamab) • utidelone IV (UTD1)
    10ms
    Utidelone in combination with etoposide and bevacizumab in HER2-negative breast cancer with brain metastasis (UTOBIA-BM): A prospective, single-arm, phase II trial (ESMO 2023)
    No treatment-related death occurred. Conclusions Utidelone in combination with etoposide and bevacizumab has shown anti-tumor activity and manageable toxicity in breast cancer pts with brain metastasis, and a randomized control trial is warrantied.
    Clinical • P2 data • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Avastin (bevacizumab) • etoposide IV • utidelone IV (UTD1)
    11ms
    Utidelone Treated for the Recurrent or Metastatic Urothelial Carcinoma (clinicaltrials.gov)
    P2, N=34, Recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    New P2 trial • Metastases
    |
    utidelone IV (UTD1)
    12ms
    Utidelone and Anlotinib in Advanced Recurrent Metastatic Esophageal Cancer (clinicaltrials.gov)
    P2, N=47, Recruiting, Peking University
    New P2 trial • Metastases
    |
    Focus V (anlotinib) • utidelone IV (UTD1)
    over1year
    Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=349, Recruiting, Sun Yat-sen University | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    docetaxel • utidelone IV (UTD1)
    over1year
    Utidelone in Combination With AC Versus Docetaxel in Combination With AC for Neoadjuvant Chemotherapy in Patients With HER2-negative Breast Cancer (clinicaltrials.gov)
    P3, N=552, Not yet recruiting, Beijing Biostar Pharmaceuticals Co., Ltd.
    New P3 trial • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    docetaxel • doxorubicin hydrochloride • cyclophosphamide • utidelone IV (UTD1)
    over1year
    Utidelone Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=612, Not yet recruiting, Beijing Biostar Pharmaceuticals Co., Ltd.
    New P3 trial • Metastases
    |
    ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • ALK positive • EGFR T790M • ALK fusion • EGFR positive
    |
    docetaxel • utidelone IV (UTD1)
    almost2years
    Exploratory Study of Advanced Breast Cancer in HER2 Positive Patients With Failure of Multi-line Therapy Treated by Combination of Inetetamab (Cipterbin) + PD-1 Inhibitor Combined With Utidelone. (clinicaltrials.gov)
    P2, N=46, Recruiting, Henan Cancer Hospital | Trial primary completion date: Apr 2022 --> Nov 2021
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification
    |
    gemcitabine • capecitabine • albumin-bound paclitaxel • vinorelbine tartrate • Cipterbin (inetetamab) • utidelone IV (UTD1)
    almost2years
    Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=349, Not yet recruiting, Sun Yat-sen University
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    docetaxel • utidelone IV (UTD1)
    almost2years
    Weekly Utidelone in HER2-negative Inoperable Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=61, Not yet recruiting, Fudan University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    utidelone IV (UTD1)
    almost2years
    Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=71, Not yet recruiting, Henan Cancer Hospital
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    Avastin (bevacizumab) • utidelone IV (UTD1)
    over2years
    Utidelone Plus Capecitabine Versus Taxane Plus Capecitabine in HER2-negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=512, Not yet recruiting, Sun Yat-sen University
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    docetaxel • capecitabine • albumin-bound paclitaxel • utidelone IV (UTD1)
    over2years
    Exploratory Study of Advanced Breast Cancer in HER2 Positive Patients With Failure of Multi-line Therapy Treated by Combination of Inetetamab (Cipterbin) + PD-1 Inhibitor Combined With Utidelone. (clinicaltrials.gov)
    P2, N=46, Recruiting, Henan Cancer Hospital | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification
    |
    gemcitabine • capecitabine • albumin-bound paclitaxel • vinorelbine tartrate • Cipterbin (inetetamab) • utidelone IV (UTD1)