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    DRUG:

    tagitanlimab (HBM9167)

    i
    Other names: HBM9167, A 167, KL A167, KLA167, A167, KL-A167, A-167, HBM 9167, HBM-9167
    Associations

    News

    Trials
    Company:
    Harbour BioMed, Sichuan Kelun Pharma
    Drug class:
    PD-L1 inhibitor
    Related drugs:
    Associations

    News

    Trials
    7ms
    Sacituzumab tirumotecan (SKB264/MK-2870) in combination with KL-A167 (anti-PD-L1) as first-line treatment for patients with advanced NSCLC from the phase II OptiTROP-Lung01 study. (ASCO 2024)
    Background: Sacituzumab Tirumotecan (SKB264/MK-2870)is a TROP2 ADC developed with novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor. SKB264 in combination with KL-A167 demonstrated promising efficacy results in treatment naive advanced NSCLC with manageable safety profile. SKB264 Q2W was recommended for further investigation. A Phase 3 study of SKB264 Q2W plus pembrolizumab vs pembrolizumab in 1L metastatic NSCLC with PD-L1 TPS ≥ 50% (NCT06170788) is ongoing.
    Combination therapy • P2 data • Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • sacituzumab tirumotecan (MK-2870) • Camtobell (belotecan) • tagitanlimab (HBM9167)
    12ms
    SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer. (clinicaltrials.gov)
    P2, N=110, Recruiting, Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | Not yet recruiting --> Recruiting | Trial completion date: Apr 2025 --> Apr 2026 | Trial primary completion date: Aug 2023 --> Aug 2024
    Enrollment open • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • EGFR wild-type • ALK fusion • ALK negative
    |
    cisplatin • carboplatin • sacituzumab tirumotecan (MK-2870) • tagitanlimab (HBM9167)
    1year
    An Open, Multicenter Phase II Study to Evaluate the Safety and Efficacy of KL-A167 Injection in Relapsed or Refractory Classical Hodgkin's Lymphoma (clinicaltrials.gov)
    P2, N=109, Completed, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Unknown status --> Completed
    Trial completion
    |
    tagitanlimab (HBM9167)
    1year
    KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov)
    P3, N=295, Active, not recruiting, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Not yet recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    cisplatin • gemcitabine • tagitanlimab (HBM9167)
    1year
    SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer (clinicaltrials.gov)
    P2, N=175, Recruiting, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting | N=95 --> 175 | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Apr 2024 --> Apr 2025
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    sacituzumab tirumotecan (MK-2870) • tagitanlimab (HBM9167)
    over2years
    A Phase Ⅱ Clinical Study of Combination Therapy of SKB264 in Patients With Advanced or Metastatic Non-small Cell Lung Cancer. (clinicaltrials.gov)
    P2, N=110, Not yet recruiting, Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
    New P2 trial • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • EGFR wild-type • ALK fusion • ALK negative
    |
    cisplatin • carboplatin • sacituzumab tirumotecan (MK-2870) • tagitanlimab (HBM9167)