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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: 26 Jun 2025

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At a glance

Most Recent Events

  • 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.
  • 03 Apr 2025 According to a Greenwich LifeSciences Inc media release, the company is now considering the merits of adding a randomized placebo arm for non-HLA-A*02 patients, transforming this current open label third arm into effectively a second pivotal and blinded Phase III trial, which will enable the pursual of approval for both HLA-A*02 and non-HLA-A*02 patients in similar time frames using independent or combined analysis of the two patient groups.
  • 03 Apr 2025 Results presented in the Greenwich LifeSciences Inc Media Release.

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