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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05232916

Public ClinicalTrials.gov record NCT05232916. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 4, 2026, 11:18 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05232916
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Greenwich LifeSciences, Inc.
Industry
Enrollment
2,250 participants

Conditions and interventions

Conditions

Interventions

Biological

Eligibility (public fields only)

Age range
18 Years to 100 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 15, 2022
Primary completion
Nov 30, 2031
Completion
Nov 30, 2031
Last update posted
Aug 5, 2026

2022 – 2031

United States locations

U.S. sites
51
U.S. states
24
U.S. cities
47
Facility City State ZIP Site status
Southern Cancer Center Mobile Alabama 36607 Not yet recruiting
City of Hope - Cancer Center Phoenix Goodyear Arizona 85338 Recruiting
Tucson Medical Center HealthCare Tucson Arizona 85704 Recruiting
City of Hope - Duarte Cancer Center Duarte California 91010 Recruiting
Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center Fullerton California 92835 Recruiting
City of Hope - Orange County Lennar Foundation Cancer Center Irvine California 92618 Recruiting
University of California San Diego - Moores Cancer Center La Jolla California 92093 Recruiting
University of Southern California - Norris Comprehensive Cancer Center Los Angeles California 90033 Active, not recruiting
Stanford Medicine Cancer Center - Stanford Women's Cancer Center Palo Alto California 74304 Recruiting
University of California San Francisco - Helen Diller Family Comprehensive Cancer Center San Francisco California 94158 Recruiting
University of California Los Angeles - Hematology / Oncology Parkside Santa Monica California 90404 Recruiting
PIH Health Hospital - Whittier Hospital Whittier California 90602 Recruiting
Rocky Mountain Cancer Centers Denver Colorado 80220 Recruiting
Yale Cancer Center - Smilow Cancer Hospital New Haven Connecticut 06511 Recruiting
Johns Hopkins Medicine - Kimmel Cancer Center-Sibley Memorial Hospital Washington D.C. District of Columbia 20016 Recruiting
University of Miami - Sylvester Comprehensive Cancer Center Miami Florida 33146 Recruiting
Moffitt Cancer Center Tampa Florida 33612 Recruiting
City of Hope - Cancer Center Atlanta Newnan Georgia 30265 Recruiting
Northwestern University - Northwestern Memorial Hospital Chicago Illinois 60611 Recruiting
City of Hope - Cancer Center Chicago Zion Illinois 60099 Recruiting
Maryland Oncology Hematology Annapolis Maryland 21401 Recruiting
Massachusetts General Hospital Cancer Center Boston Massachusetts 02114 Recruiting
Minnesota Oncology Maple Grove Minnesota 55369 Recruiting
Siteman Cancer Center - Washington University Medical Campus St Louis Missouri 63110 Recruiting
Nebraska Cancer Specialists Omaha Nebraska 68114 Recruiting
Nebraska Medicine - University of Nebraska Medical Center Omaha Nebraska 68198 Recruiting
Comprehensive Cancer Centers of Nevada Henderson Nevada 89052 Recruiting
Cooper University Health Care Camden New Jersey 08103 Active, not recruiting
New York Oncology Hematology Albany New York 12065 Recruiting
New York-Presbyterian - Columbia University Irving Medical Center New York New York 10032 Recruiting
Stony Brook University Cancer Center Stony Brook New York 11794 Recruiting
Oncology Hematology Care Cincinnati Ohio 45211 Recruiting
Hematology Oncology Associates Medford Oregon 97504 Not yet recruiting
Compass Oncology - Northwest Cancer Specialists Tigard Oregon 97223 Recruiting
Redeemer Health - Holy Redeemer Hospital Meadowbrook Pennsylvania 19046 Recruiting
Sidney Kimmel Comprehensive Cancer Center - Thomas Jefferson University Hospital Philadelphia Pennsylvania 19107 Recruiting
Tennessee Cancer Specialists Knoxville Tennessee 37909 Not yet recruiting
SCRI Oncology Partners Nashville Tennessee 37203 Not yet recruiting
Texas Oncology - Austin Austin Texas 78745 Recruiting
Texas Oncology - Dallas Presbyterian Hospital Dallas Texas 75231 Recruiting
Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas 75246 Recruiting
The University of Texas Southwestern Medical Center Dallas Texas 75390 Recruiting
Baylor College of Medicine - Dan L. Duncan Comprehensive Cancer Center Houston Texas 77057 Recruiting
The University of Texas Health Sciences Center at San Antonio - Mays Cancer Center San Antonio Texas 78229 Recruiting
Texas Oncology - San Antonio Medical Center San Antonio Texas 78240 Recruiting
Texas Oncology - Gulf Coast Sugar Land Texas 77479 Recruiting
Texas Oncology - Tyler Tyler Texas 75702 Recruiting
University of Utah - Huntsman Cancer Institute Salt Lake City Utah 84112 Recruiting
Virginia Cancer Specialists Fairfax Virginia 22031 Recruiting
Virginia Oncology Associates Norfolk Virginia 23502 Not yet recruiting
Shenandoah Oncology Winchester Virginia 22601 Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 128 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05232916, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 5, 2026 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05232916 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →