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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: 09 Jan 2026

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At a glance

Most Recent Events

  • 29 Dec 2025 According to a Greenwich LifeSciences media release, to support this trial, the company has extended the lock-up of the shares owned by the Company's directors, officers, and existing pre-IPO investors to September 30, 2026 which is approximately 72 months from the date of the Company's IPO.
  • 22 Dec 2025 According to a Greenwich LifeSciences media release, the company has planned following modifications in this trial- increasing study size, doubling or quadrupling the enrollment rate, using the interim analysis to potentially resize the study and continuing to enroll past the interim analyses.
  • 22 Dec 2025 According to a Greenwich LifeSciences media release, FLAMINGO-01 DSMB met twice in 2025, with a recent meet in Dec-2025, and recommended to continue the study without modification. The Steering Committee also met at SABCS 2025 and discussed the clinical strategy, endorsing the planned modifications to FLAMINGO-01.

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