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Study identifier: NCT05232916 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Breast Cancer  ·  Sponsor: Greenwich LifeSciences, Inc.

PhasePhase 3
Planned participants750
Who can joinAll sexes, 18 Years to 100 Years
Healthy volunteersNo

About this study

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. A third open-label arm will explore GLSI-100 immunotherapy in non-HLA-A\*02 positive and HER2/neu positive subjects.

This description comes directly from the study's public registry record.

Talk to the study team

Jaye L Thompson, Ph.D.  ·  (832) 791-2542  ·  Jaye.Thompson@GreenwichLifeSciences.com

Always discuss trial participation with your own doctor first.

Locations (179)

Southern Cancer CenterMobile, Alabama, United StatesNot Yet Recruiting
City of Hope - Cancer Center PhoenixGoodyear, Arizona, United StatesRecruiting
Tucson Medical Center HealthCareTucson, Arizona, United StatesRecruiting
City of Hope - Duarte Cancer CenterDuarte, California, United StatesRecruiting
Providence St. Jude Medical Center - Virginia K. Crosson Cancer CenterFullerton, California, United StatesRecruiting
City of Hope - Orange County Lennar Foundation Cancer CenterIrvine, California, United StatesRecruiting
University of California San Diego - Moores Cancer CenterLa Jolla, California, United StatesRecruiting
University of Southern California - Norris Comprehensive Cancer CenterLos Angeles, California, United StatesActive Not Recruiting
Stanford Medicine Cancer Center - Stanford Women's Cancer CenterPalo Alto, California, United StatesRecruiting
University of California San Francisco - Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United StatesRecruiting
University of California Los Angeles - Hematology / Oncology ParksideSanta Monica, California, United StatesRecruiting
PIH Health Hospital - Whittier HospitalWhittier, California, United StatesRecruiting

+ 167 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05232916