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A Phase 1/1b Open-label, First-in-human, Single Agent, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors

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Trial Profile

A Phase 1/1b Open-label, First-in-human, Single Agent, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 14 Feb 2024

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At a glance

  • Drugs SAR 443216 (Primary) ; SAR 443216 (Primary)
  • Indications Advanced breast cancer; Gastric cancer; Non-small cell lung cancer; Solid tumours
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Sanofi
  • Most Recent Events

    • 07 Feb 2024 Status changed from recruiting to discontinued (sponsor's decision, unrelated to safety profile).
    • 24 Oct 2023 As of April 2023, 29 patients have been enrolled, as per trial design presented at the 48th European Society for Medical Oncology Congress.
    • 24 Oct 2023 Trial design presented at the 48th European Society for Medical Oncology Congress.

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