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    DRUG:

    ASP2138

    i
    Other names: ASP2138, ASP 2138, ASP-2138
    Company:
    Astellas, Xencor
    Drug class:
    CD3 agonist, CLDN18.2 inhibitor
    Related drugs:
    2ms
    A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer (clinicaltrials.gov)
    P1, N=305, Recruiting, Astellas Pharma Global Development, Inc. | Trial completion date: Dec 2026 --> Apr 2027 | Trial primary completion date: Jun 2026 --> Oct 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • paclitaxel • 5-fluorouracil • Cyramza (ramucirumab) • oxaliplatin • irinotecan • leucovorin calcium • ASP2138
    3ms
    A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer (clinicaltrials.gov)
    P1, N=305, Recruiting, Astellas Pharma Global Development, Inc. | Trial completion date: Jun 2026 --> Dec 2026
    Trial completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • paclitaxel • 5-fluorouracil • Cyramza (ramucirumab) • oxaliplatin • irinotecan • leucovorin calcium • ASP2138
    8ms
    A Study of ASP2138 in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, Pancreatic Cancer (clinicaltrials.gov)
    P1, N=275, Recruiting, Astellas Pharma Global Development, Inc. | Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Dec 2025 --> Jun 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    ASP2138
    over1year
    ASP2138, a novel 2+1 format, claudin 18.2 x CD3 bispecific antibody, demonstrates selectivity and activity in preclinical cancer models (AACR 2023)
    ASP2138 exhibited an antitumor effect on human CLDN18.2-expressing gastric cancer in a human PBMC-engrafted NOG mouse model in vivo. In summary, ASP2138 is expected to show a clinical effect through cytotoxicity against CLDN18.2-expressing tumor cells by T-cell activation that results from selective binding to CLDN18.2 and CD3.
    Preclinical • IO biomarker
    |
    CLDN18 (Claudin 18) • IFNG (Interferon, gamma)
    |
    CLDN18.2 expression • CLDN18.2 positive • IFNG expression
    |
    ASP2138
    over2years
    A Study of ASP2138 in Adults With Stomach Cancer or Pancreatic Cancer (clinicaltrials.gov)
    P1, N=240, Recruiting, Astellas Pharma Global Development, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18) • CA 19-9 (Cancer antigen 19-9)
    |
    PD-L1 expression • CLDN18.2 expression
    |
    ASP2138
    over2years
    A Study of ASP2138 in Adults With Stomach Cancer or Pancreatic Cancer (clinicaltrials.gov)
    P1, N=240, Not yet recruiting, Astellas Pharma Global Development, Inc.
    New P1 trial • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18) • CA 19-9 (Cancer antigen 19-9)
    |
    PD-L1 expression • CLDN18.2 expression
    |
    ASP2138