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A Phase I-II Multicenter, Open Label Trial of H3B-6545, a Covalent Antagonist of Estrogen Receptor Alpha, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer

Trial Profile

A Phase I-II Multicenter, Open Label Trial of H3B-6545, a Covalent Antagonist of Estrogen Receptor Alpha, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 27 Sep 2019

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At a glance

  • Drugs H3B-6545 (Primary)
  • Indications Advanced breast cancer
  • Focus Adverse reactions
  • Sponsors H3 Biomedicine
  • Most Recent Events

    • 04 Jun 2019 Results (n=32, as of 10th Dec 2018) of phase I portion assessing the safety, pharmacokinetics and pharmacodynamics of H3B-6545 in women with HR+ breast cancer to identify the recommended Phase 2 dose, were presented at the 55th Annual Meeting of the American Society of Clinical Oncology.
    • 04 Jun 2019 Results assessing hotspot mutation profiles, prediction of response to H3B-6545 based on mutations in ESR1 or PIK3CA and longitudinal tracking of ctDNA correlation with response to H3B-6545 from Phase I portion of this trial presented at the 55th Annual Meeting of the American Society of Clinical Oncology
    • 29 May 2019 Planned End Date changed from 1 Dec 2019 to 31 May 2020.
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