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A Phase 1, Multicenter, Open-label, Multiple Dose-escalation Study of ARX788, Intravenously Administered as a Single Agent in Subjects With Advanced Cancers With HER2 Expression

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A Phase 1, Multicenter, Open-label, Multiple Dose-escalation Study of ARX788, Intravenously Administered as a Single Agent in Subjects With Advanced Cancers With HER2 Expression

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs ARX 788 (Primary)
  • Indications Advanced breast cancer; Gastric cancer; HER2 positive breast cancer
  • Focus Adverse reactions; First in man
  • Sponsors Zhejiang Medicine

Most Recent Events

  • 04 Jan 2021 According to an Ambrx media release, the U.S. Food and Drug Administration (FDA) granted ARX788 Fast Track Designation as monotherapy for the treatment of advanced or metastatic HER2-positive breast cancer patients who have received one or more prior anti-HER2 based regimens in the metastatic setting, based on data from phase 1 studies.
  • 03 Jun 2020 Status changed from recruiting to discontinued.
  • 26 Jun 2017 Planned End Date changed from 1 Sep 2017 to 1 Dec 2018.

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