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A Randomized, Multicenter, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu Positive Subjects with Residual Disease or High-Risk PCR After Both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy (FLAMINGO-01)

Trial Profile

A Randomized, Multicenter, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu Positive Subjects with Residual Disease or High-Risk PCR After Both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy (FLAMINGO-01)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Oct 2025

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At a glance

Most Recent Events

  • 13 Aug 2025 According to a Greenwich LifeSciences Inc media release, Dr. Antone will be serving as the national principal investigator in Romania for FLAMINGO-01.
  • 13 Aug 2025 According to a Greenwich LifeSciences Inc media release, company announced the addition of clinical sites in Romania, and this has been formally approved by European regulators, thus adding Romanian sites to the approximately 150 approved sites in Spain, France, Germany, Italy, Poland and the US. At present, there are approximately 123 actively enrolling sites globally.
  • 03 Apr 2025 According to a Greenwich LifeSciences Inc media release, the company has analyzed the preliminary immune response data from open-label part of FLAMINGO-01.

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