# Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects

Source: https://onco.cc/trials/nct05232916/  
OnCo record `nct05232916` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial testing GLSI-100 in HR-positive / HER2-negative breast cancer, now recruiting.

## Summary

Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects is a phase 3 interventional study registered as NCT05232916, led by Greenwich LifeSciences, and recruiting on the registry. Official title: A Randomised, 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). Planned enrolment is 2250 participants (estimated). The study started in 2022-12-16 and primary completion is expected in 2031-12. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-11
- Also known as: FLAMINGO-01
- Tags: ctgov-ingest
- Registry id: NCT05232916
- Phase: 3
- Setting: 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)
- Sponsor: Greenwich LifeSciences
- Enrolled: 2250

## Sources

- ClinicalTrials.gov NCT05232916: https://clinicaltrials.gov/study/NCT05232916

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- drugs: [GLSI-100](https://onco.cc/drugs/glsi-100/)
- companies: [Greenwich LifeSciences](https://onco.cc/companies/greenwich-lifesciences/)

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