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

Summary

This is a prospective, randomized, double-blinded, placebo-controlled, multi-center, Phase 3 study of GLSI-100 immunotherapy in HLA-A*02 positive and HER2/neu positive subjects who are at high risk for disease recurrence and have completed both neoadjuvant and postoperative adjuvant standard of care therapy. Treatment consists of 6 intradermal injections, Primary Immunization Series (PIS), over the first 6 months of treatment and 5 booster intradermal injections spaced 6 months apart.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Breast Cancer

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

18 to 100 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

Greenwich LifeSciences, Inc.

Last updated on ClinicalTrials.gov

August 6, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites