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Phase Ia/Ib, Open-label, Multicenter, Dose-escalation Study Followed by an Extension Phase to Evaluate Safety, Pharmacokinetics and Activity of RO5479599, a Glycoengineered Antibody Against HER3, Administered Either Alone (Part A) or in Combination With Cetuximab (Part B) or in Combination With Erlotininb (Part C) in Patients With Metastatic and/or Locally Advanced Malignant HER3-positive Solid Tumors of Ephitelian Cell Origin

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Trial Profile

Phase Ia/Ib, Open-label, Multicenter, Dose-escalation Study Followed by an Extension Phase to Evaluate Safety, Pharmacokinetics and Activity of RO5479599, a Glycoengineered Antibody Against HER3, Administered Either Alone (Part A) or in Combination With Cetuximab (Part B) or in Combination With Erlotininb (Part C) in Patients With Metastatic and/or Locally Advanced Malignant HER3-positive Solid Tumors of Ephitelian Cell Origin

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Lumretuzumab (Primary) ; Cetuximab; Erlotinib; Zirconium-89 lumretuzumab
  • Indications Colorectal cancer; Head and neck cancer; Non-small cell lung cancer; Solid tumours
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Sponsors Roche

    • Most Recent Events

    • 12 Jul 2017 Results (n=20) published in the Clinical cancer research: an official journal of the American Association for Cancer Research.
    • 01 Jun 2017 Pharmacokinetic and pharmacodynamic data from the first few patients published in the Cancer Chemotherapy and Pharmacology
    • 11 Oct 2016 Results (n=32) of a biomarker analysis presented at the 41st European Society for Medical Oncology Congress.

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