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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)

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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: 17 Dec 2025

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At a glance

Most Recent Events

  • 08 Dec 2025 Results presented in the Greenwich LifeSciences Inc media release.
  • 09 Oct 2025 According to a Greenwich LifeSciences Inc media release, the Company's application to European regulators has been formally approved, adding Austria as an approved country in FLAMINGO-01 in addition to Spain, France, Germany, Italy, Poland, Romania, Ireland, Portugal, Belgium, and the US.
  • 02 Oct 2025 According to a Greenwich LifeSciences media release, company announced the expansion of FLAMINGO-01 clinical trial to Belgium. The Company's application to European regulators has been formally approved, adding Belgium as an approved country in FLAMINGO-01 in addition to Spain, France, Germany, Italy, Poland, Romania, Ireland, Portugal, and the US. The Company is collaborating with Patrick Neven, MD, PhD, at UZ Leuven, who will be serving as the national principal investigator in Belgium.

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