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An Open-Label, Multicenter, Dose-Escalation, Phase Ia/Ib Study to Evaluate Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281, an Immunocytokine Consisting of Interleukin 2 Variant (IL-2v) Targeting Fibroblast Activation Protein-α (FAP), as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C)

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Trial Profile

An Open-Label, Multicenter, Dose-Escalation, Phase Ia/Ib Study to Evaluate Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281, an Immunocytokine Consisting of Interleukin 2 Variant (IL-2v) Targeting Fibroblast Activation Protein-α (FAP), as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 23 Nov 2022

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At a glance

  • Drugs Simlukafusp alfa (Primary) ; Cetuximab; Trastuzumab
  • Indications Advanced breast cancer; Head and neck cancer; HER2 positive breast cancer; Hypopharyngeal cancer; Laryngeal cancer; Mouth neoplasm; Nasopharyngeal cancer; Oropharyngeal cancer; Solid tumours; Squamous cell cancer
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Sponsors Roche

    • Most Recent Events

    • 21 Nov 2022 Status changed from active, no longer recruiting to completed.
    • 25 Jan 2022 Planned End Date changed from 31 Dec 2021 to 31 Dec 2022.
    • 25 Jan 2022 Planned primary completion date changed from 31 Dec 2021 to 31 Dec 2022.

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