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    DRUG:

    SAR443216

    i
    Other names: SAR443216
    Company:
    Sanofi
    Drug class:
    HER2 inhibitor, CD3 agonist, T-cell stimulant, CD28 agonist
    Related drugs:
    3ms
    Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors (clinicaltrials.gov)
    P1, N=44, Terminated, Sanofi | N=200 --> 44 | Trial completion date: Feb 2026 --> Jan 2024 | Recruiting --> Terminated | Trial primary completion date: Feb 2026 --> Jan 2024; Sponsor's decision. Termination decision unrelated to safety profile
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    SAR443216
    10ms
    A phase I/Ib open-label, first-in-human, single agent, dose escalation and expansion study of a HER2-targeted T cell engager (SAR443216) in patients with relapsed/refractory HER2-expressing solid tumors (ESMO 2023)
    Nature. 2022; 603:328-334.
    Clinical • P1 data
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 mutation • HER-2 expression
    |
    SAR443216
    over1year
    Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors (clinicaltrials.gov)
    P1, N=200, Recruiting, Sanofi | Trial completion date: Jun 2025 --> Sep 2025 | Trial primary completion date: Jun 2025 --> Sep 2025
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    SAR443216
    over1year
    Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors (clinicaltrials.gov)
    P1, N=184, Recruiting, Sanofi | Trial completion date: Nov 2025 --> Jun 2025 | Trial primary completion date: Nov 2025 --> Jun 2025
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    SAR443216
    2years
    Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors (clinicaltrials.gov)
    P1, N=184, Recruiting, Sanofi | Trial completion date: Jun 2025 --> Nov 2025 | Trial primary completion date: Jun 2025 --> Nov 2025
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    SAR443216
    over2years
    Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors (clinicaltrials.gov)
    P1, N=184, Recruiting, Sanofi | Not yet recruiting --> Recruiting | Trial completion date: Oct 2023 --> Jun 2025 | Trial primary completion date: Oct 2023 --> Jun 2025
    Clinical • Enrollment open • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    SAR443216
    over2years
    Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors (clinicaltrials.gov)
    P1, N=184, Not yet recruiting, Sanofi
    Clinical • New P1 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    SAR443216