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

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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