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    DRUG:

    anbenitamab (KN026)

    i
    Other names: KN026, KN-026, KN 026
    Company:
    Alphamab, CSPC Pharma
    Drug class:
    HER2 inhibitor
    Related drugs:
    6ms
    JSKN003 Combined Treatment of HER2-positive Gastric Cancer (clinicaltrials.gov)
    P2, N=153, Not yet recruiting, Shanghai JMT-Bio Inc.
    New P2 trial
    |
    Herceptin (trastuzumab) • capecitabine • oxaliplatin • anbenitamab (KN026) • Enshuxing (enlonstobart) • anbenitamab repodatecan (JSKN003)
    6ms
    Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer. (clinicaltrials.gov)
    P3, N=880, Recruiting, Shanghai JMT-Bio Inc. | Not yet recruiting --> Recruiting | Trial primary completion date: Jul 2026 --> Jul 2025
    Enrollment open • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • anbenitamab (KN026)
    7ms
    A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer (clinicaltrials.gov)
    P3, N=520, Recruiting, Shanghai JMT-Bio Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Herceptin (trastuzumab) • carboplatin • docetaxel • Perjeta (pertuzumab) • anbenitamab (KN026)
    8ms
    Safety and Efficacy of KN046 in combination with KN026 in Patients with advanced HER2-positive Breast Cancer: a Phase II Trial. (PubMed, Clin Cancer Res)
    The combination of KN046 and KN026, as a chemo free regimen, demonstrated favorable clinical efficacy with comparative toxicities in pre-treated patients with advanced HER2-positive breast cancer.
    P2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    erfonrilimab (KN046) • anbenitamab (KN026)
    9ms
    Efficacy and safety of KN026, a bispecific anti-HER2 antibody, in combination with KN046, an anti-CTLA4/PD-L1 antibody, in patients with advanced HER2-positive nonbreast cancer: a combined analysis of a phase Ib and a phase II study. (PubMed, Signal Transduct Target Ther)
    In the other HER2-positive solid tumor subgroup (n = 34), the ORR was 52.9% (95%CI 35.1%,70.2%). Thus, KN026 plus KN04 exhibits promising efficacy and acceptable safety profiles in HER2-positive nonbreast cancer, as does the 1st-line treatment for GC.
    P1 data • P2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • CD4 (CD4 Molecule)
    |
    HER-2 positive
    |
    erfonrilimab (KN046) • anbenitamab (KN026)
    11ms
    Efficacy and safety of KN026 and docetaxel for HER2-positive breast cancer: a phase II clinical trial. (PubMed, Cancer Commun (Lond))
    KN026 plus docetaxel showed promising efficacy and a manageable safety profile in first-line treatment of HER2-positive recurrent/metastatic breast cancer.
    P2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • EGFR positive
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • anbenitamab (KN026)
    11ms
    A Phase III Study of KN026 in Combination With HB1801 as Neoadjuvant Therapy for Early or Locally Advanced HER2-Positive Breast Cancer (clinicaltrials.gov)
    P3, N=520, Not yet recruiting, Shanghai JMT-Bio Inc.
    New P3 trial
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • anbenitamab (KN026)
    1year
    Disitamab vedotin combined with apatinib in gastric cancer: A case report and review of literature. (PubMed, World J Clin Oncol)
    Despite the unfavorable prognosis associated with advanced GC, the implementation of personalized treatment approaches may still prove beneficial for select patients. In patients with HER2-positive GC with extensive metastatic involvement, the use of the HER2-targeted combination with apatinib has demonstrated the potential to prolong both PFS and overall survival.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • HER-2 positive • MSI-H/dMMR • HER-2 overexpression • HER-2 amplification • HER-2 amplification + PD-L1 expression • HER-2 positive + HER-2 overexpression
    |
    Opdivo (nivolumab) • Herceptin (trastuzumab) • AiTan (rivoceranib) • Aidixi (disitamab vedotin) • anbenitamab (KN026)
    over1year
    Phase 2 Trial of KN026+KN046±XELOX in HER2-positive Locally Advanced GC (clinicaltrials.gov)
    P2, N=18, Recruiting, Peking University | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    capecitabine • oxaliplatin • erfonrilimab (KN046) • anbenitamab (KN026)
    over1year
    KN026 Combined With KN046 in Subjects With HER2 Positive Solid Tumor (clinicaltrials.gov)
    P1, N=48, Completed, Peking University | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    erfonrilimab (KN046) • anbenitamab (KN026)
    over1year
    KN026-CHN-001: Trial of KN026 in Patients With HER2-positive Advanced Malignant Breast Cancer and Gastric Cancer (clinicaltrials.gov)
    P1, N=63, Completed, Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    anbenitamab (KN026)