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Phase I, First-in-Human, Open-Label, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of M6223, an Inhibitor of TIGIT, as Single Agent and in Combination With Bintrafusp Alfa (Anti-PDL1/ TGFß Trap) in Participants With Metastatic or Locally Advanced Solid Unresectable Tumors

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Trial Profile

Phase I, First-in-Human, Open-Label, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of M6223, an Inhibitor of TIGIT, as Single Agent and in Combination With Bintrafusp Alfa (Anti-PDL1/ TGFß Trap) in Participants With Metastatic or Locally Advanced Solid Unresectable Tumors

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Jun 2024

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At a glance

  • Drugs Bintrafusp alfa (Primary) ; M 6223 (Primary)
  • Indications Solid tumours
  • Focus Adverse reactions; First in man
  • Sponsors EMD Serono Research & Development Institute
  • Most Recent Events

    • 10 Apr 2024 Results(n= 40 pts ) evaluating safety profile, and RDEs for both mono- and combination therapy, presented at the 115th Annual Meeting of the American Association for Cancer Research
    • 07 Dec 2023 Status changed from active, no longer recruiting to completed.
    • 07 Aug 2023 Planned End Date changed from 14 Jun 2023 to 11 Sep 2023.
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