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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
    1m
    Utidelone combined with anti‑angiogenic therapy for the treatment of anthracycline/taxane‑treated and endocrine‑resistant HR+/HER2‑ refractory breast cancer with brain metastases: A case report. (PubMed, Oncol Lett)
    This result was superior to the second-line treatment with nab-paclitaxel, which resulted in a PFS of 8 months and best overall response of stable disease with slight shrinkage. The present case indicates that a combination of utidelone with apatinib/anlotinib exhibited antitumor activity in a patient with HR+/HER2- mBC with BMs. Therefore, this combination offers a promising therapeutic option for the clinical treatment of patients with breast cancer and BMs.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
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    Focus V (anlotinib) • AiTan (rivoceranib) • albumin-bound paclitaxel • utidelone IV (UTD1)
    1m
    Utidelone Injection Combined with Bevacizumab Injection for Non-small Cell Lung Cancer Patients with Brain Metastases (clinicaltrials.gov)
    P2, N=118, Not yet recruiting, Beijing Biostar Pharmaceuticals Co., Ltd.
    New P2 trial
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    Avastin (bevacizumab) • utidelone IV (UTD1)
    2ms
    Utidelone plus pembrolizumab as the fourth-line combination treatment in non-small cell lung cancer with EGFR mutation: a case report. (PubMed, Anticancer Drugs)
    The patient had progressed after targeted therapy with oxitinib, ametinib, and vometinib. Although peripheral neurotoxicity occurred during treatment, it improved after symptomatic treatment. The treatment of EGFR mutant stage IV NSCLC with utidelone combined with pabolizumab has good effect and mild adverse reactions.
    Journal • PD(L)-1 Biomarker
    |
    EGFR (Epidermal growth factor receptor) • PGR (Progesterone receptor)
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    EGFR mutation
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    Keytruda (pembrolizumab) • Tagrisso (osimertinib) • Ivesa (firmonertinib) • utidelone IV (UTD1)
    3ms
    ORIENTA: Organoid-based Functional Precision Therapy for Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=252, Recruiting, Guangdong Provincial People's Hospital | Initiation date: Jan 2024 --> Sep 2024
    Trial initiation date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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    HR positive • HER-2 negative • ER positive + PGR positive • HER-2 negative + ER positive • HER-2 negative + HR negative
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    carboplatin • gemcitabine • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • albumin-bound paclitaxel • cyclophosphamide • Halaven (eribulin mesylate) • pegylated liposomal doxorubicin • vinorelbine tartrate • Trodelvy (sacituzumab govitecan-hziy) • Lipusu (liposomal paclitaxel) • utidelone IV (UTD1)
    3ms
    A single-arm, prospective phase Ⅱ clinical study of Utidelone combined with capecitabine in the treatment of active brain metastasis of triple-negative advanced breast cancer. (ChiCTR2400088235)
    P2, N=48, Not yet recruiting, Henan Cancer Hospital; Henan Cancer Hospital
    New P2 trial • Metastases
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    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 negative
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    capecitabine • utidelone IV (UTD1)
    3ms
    A Single-arm, Prospective Phase Ⅱ Clinical Study of Utidelone Combined with Capecitabine in the Treatment of Active Brain Metastasis of TNBC (clinicaltrials.gov)
    P2, N=48, Recruiting, Henan Cancer Hospital
    New P2 trial • Metastases
    |
    capecitabine • utidelone IV (UTD1)
    5ms
    Neoadjuvant Therapy With Weekly Utidelone Combined With Cisplatin for Patients With Breast Cancer (NeoURANIA) (clinicaltrials.gov)
    P2, N=143, Not yet recruiting, RenJi Hospital
    New P2 trial
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    Herceptin (trastuzumab) • cisplatin • Perjeta (pertuzumab) • utidelone IV (UTD1)
    5ms
    Single-arm, Phase II Clinical Trial of Utidelone Capsule Plus Capecitabine (CAP) in Patients with Metastatic Breast Cancer (ChiCTR2400085074)
    P2, N=40, Not yet recruiting, Henan Cancer hospital; Henan Cancer hospital
    New P2 trial
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    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    paclitaxel • capecitabine • utidelone IV (UTD1)
    5ms
    Neoadjuvant weekly utidelone combined with cisplatin in breast cancer: a prospective, multi-center study (URANIA) (ChiCTR2400084686)
    P2, N=143, Not yet recruiting, Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine; Renji Hospital affiliated to Shanghai Jiaotong University School of Medi
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    cisplatin • Perjeta (pertuzumab) • utidelone IV (UTD1)
    6ms
    Utidelone Capsule Plus Capecitabine (CAP) for Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=40, Recruiting, Min Yan, MD
    New P2 trial • Metastases
    |
    capecitabine • utidelone IV (UTD1)
    1year
    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
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    Avastin (bevacizumab) • Tevimbra (tislelizumab-jsgr) • utidelone IV (UTD1)
    1year
    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
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    docetaxel • doxorubicin hydrochloride • cyclophosphamide • utidelone IV (UTD1)
    1year
    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)
    1year
    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
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification
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    gemcitabine • capecitabine • albumin-bound paclitaxel • vinorelbine tartrate • Cipterbin (inetetamab) • utidelone IV (UTD1)
    over1year
    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
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    Herceptin (trastuzumab) • carboplatin • Perjeta (pertuzumab) • epirubicin • utidelone IV (UTD1)
    over1year
    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
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 negative
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    Avastin (bevacizumab) • etoposide IV • utidelone IV (UTD1)
    over1year
    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
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 positive
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    Irene (pyrotinib) • Cipterbin (inetetamab) • utidelone IV (UTD1)
    over1year
    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)
    over1year
    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)
    almost2years
    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)
    almost2years
    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
    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)
    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 | 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)
    over2years
    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)
    over2years
    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)
    over2years
    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)
    almost3years
    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)
    over3years
    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)