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    DRUG:

    SAR446309

    i
    Other names: SAR446309, AMX 818, HER2-XPAT, AMX-818
    Company:
    Sanofi
    Drug class:
    HER2 inhibitor, CD3 agonist, Cytotoxic T lymphocyte stimulant
    Related drugs:
    2ms
    KEYNOTE-D14: To Access the Safety and Effects of Intravenous Administration of AMX-818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers (clinicaltrials.gov)
    P1/2, N=645, Recruiting, Amunix, a Sanofi Company | Trial completion date: Dec 2026 --> Aug 2027
    Trial completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Keytruda (pembrolizumab) • SAR446309
    4ms
    KEYNOTE-D14: To Access the Safety and Effects of Intravenous Administration of AMX-818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers (clinicaltrials.gov)
    P1/2, N=575, Recruiting, Amunix, a Sanofi Company | Phase classification: P1 --> P1/2
    Phase classification • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Keytruda (pembrolizumab) • SAR446309
    1year
    Precision-activated T-cell engagers targeting HER2 or EGFR and CD3 mitigate on-target, off-tumor toxicity for immunotherapy in solid tumors. (PubMed, Nat Cancer)
    HER2-XPAT protein cleavage is low and similar in plasma samples from healthy and diseased humans and non-human primates, supporting translatability of stability to patients. EGFR-XPAT protein confirmed the utility of XPAT technology for tumor targets more widely expressed in healthy tissues.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    SAR446309