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A First-In-Human Phase I, Open-Label, Dose-Escalating Trial to Assess the Safety, Tolerability and Immunogenicity/Preliminary Antitumor Activity of ES2B-C001 With or Without [Adjuvant] in HER2 Expressing Metastatic Breast Cancer

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Trial Profile

A First-In-Human Phase I, Open-Label, Dose-Escalating Trial to Assess the Safety, Tolerability and Immunogenicity/Preliminary Antitumor Activity of ES2B-C001 With or Without [Adjuvant] in HER2 Expressing Metastatic Breast Cancer

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 30 Aug 2025

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At a glance

  • Drugs ES2B C001 (Primary) ; Montanide ISA-51 (Primary)
  • Indications Advanced breast cancer; HER2 positive breast cancer; Male breast cancer
  • Focus Adverse reactions; First in man
  • Sponsors ExpreS2ion Biotechnologies

Most Recent Events

  • 23 Jun 2025 According to the ExpreS2ion Biotechnologies media release, On 13 May 2025, company filed a protocol amendment to optionally include concurrent administration of a HER2-targeted antibody-drug conjugate (such as trastuzumab deruxtecan) in select patients. The amendment also proposes an increase in the number of clinical trial sites in Austria. A response to this amendment is expected in Q3 2025.
  • 23 Jun 2025 According to the ExpreS2ion Biotechnologies media release, company announce that the first patient has been dosed in this Phase I clinical trial.
  • 09 Jan 2025 Status changed from not yet recruiting to recruiting.

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