Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects (FLAMINGO-01)

March 17, 2026 updated by: Greenwich LifeSciences, Inc.

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)

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

750

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Avignon, France
        • Recruiting
        • Sainte-Catherine - Institut du Cancer Avignon-Provence (ICAP)
      • Brest, France
        • Recruiting
        • Clinique Pasteur-Lanroze
      • Caen, France
        • Recruiting
        • Centre Francois Baclesse (CLCC)
      • Chambray-lès-Tours, France
        • Not yet recruiting
        • Pôle Santé Léonard de Vinci
      • Cholet, France
        • Not yet recruiting
        • Centre Hospitalier de Cholet
      • Contamine-sur-Arve, France
        • Not yet recruiting
        • Centre hospitalier Alpes Léman
      • Lyon, France
        • Recruiting
        • Centre Leon Berard
      • Nantes, France
        • Not yet recruiting
        • Hôpital Privé du Confluent
      • Osny, France
        • Recruiting
        • Centre Hospitalier Privé Sainte-Marie Osny
      • Paris, France
        • Recruiting
        • Institut Curie
      • Pierre-Bénite, France
        • Not yet recruiting
        • Hospices Civils de Lyon
      • Pontoise, France
        • Recruiting
        • Hôpital NOVO (Nord-Ouest Val-d'Oise)
      • Reims, France
        • Recruiting
        • Institut Jean Godinot (CLCC)
      • Saint-Cloud, France
        • Recruiting
        • Institut Curie
      • Saint-Grégoire, France
        • Recruiting
        • Centre Hospitalier Prive Saint-Gregoire
      • Saint-Priest-en-Jarez, France
        • Recruiting
        • Centre Hospitalier Universitaire de Saint-Etienne
      • Strasbourg, France
        • Recruiting
        • Institut de cancerologie Strasbourg Europe
      • Valence, France
        • Recruiting
        • Hopital Prive Drome Ardeche
      • Vantoux, France
        • Recruiting
        • Hopital Robert Schuman
      • Villejuif, France
        • Recruiting
        • Institut Gustave Roussy
  • Germany
      • Augsburg, Germany
        • Recruiting
        • Haematologie-Onkologie im Zentrum MVZ GmbH
      • Bayreuth, Germany
        • Not yet recruiting
        • Klinikum Bayreuth GmbH
      • Berlin, Germany
        • Not yet recruiting
        • DBZ Onkologie GmbH
      • Berlin, Germany
        • Recruiting
        • Helios Klinikum Berlin-Buch GmbH
      • Bottrop, Germany
        • Recruiting
        • Marienhospital Bottrop gGmbH
      • Bremen, Germany
        • Recruiting
        • Evangelisches Diakonie-Krankenhaus gGmbH
      • Chemnitz, Germany
        • Not yet recruiting
        • Klinikum Chemnitz Ggmbh
      • Dessau, Germany
        • Recruiting
        • Städtisches Klinikum Dessau
      • Dortmund, Germany
        • Active, not recruiting
        • St.-Johannes Hospital Dortmund
      • Dresden, Germany
        • Not yet recruiting
        • Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
      • Düsseldorf, Germany
        • Recruiting
        • MVZ Medical Center Duesseldorf GmbH
      • Eggenfelden, Germany
        • Recruiting
        • Studienzentrale für das MVZ Eggenfelden e.K.
      • Essen, Germany
        • Recruiting
        • Evangelisches Kliniken Essen-Mitte gGmbH
      • Frankfurt, Germany
        • Recruiting
        • Klinikum Frankfurt Höchst GmbH
      • Freiburg im Breisgau, Germany
        • Recruiting
        • Praxis für Interdisziplinäre Onkologie und Haematologie GbR
      • Gifhorn, Germany
        • Recruiting
        • Helios Klinikum Gifhorn GmbH
      • Göttingen, Germany
        • Not yet recruiting
        • Universitätsmedizin Göttingen
      • Halle, Germany
        • Recruiting
        • Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
      • Hamburg, Germany
        • Recruiting
        • Mammazentrum Hamburg MVZ GbR
      • Harburg, Germany
        • Recruiting
        • Gynäkologische Praxisklinik Hamburg-Harburg
      • Heidelberg, Germany
        • Recruiting
        • National Center for Tumor Diseases (NCT) Heidelberg
      • Kassel, Germany
        • Recruiting
        • Elisabeth Krankenhaus GmbH
      • Krefeld, Germany
        • Not yet recruiting
        • MVZ GynKrefeld GmbH
      • Langen, Germany
        • Active, not recruiting
        • Gemeinschaftspraxis für Hämatologie und Onkologie Langen
      • Leer, Germany
        • Active, not recruiting
        • Studienzentrum UnterEms Leer
      • Ludwigsburg, Germany
        • Recruiting
        • RKH Klinken Ludwigsburg-Bietigheim gGmbH
      • Mainz, Germany
        • Not yet recruiting
        • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
      • Mannheim, Germany
        • Not yet recruiting
        • Heidelberg University
      • Munich, Germany
        • Not yet recruiting
        • München Klinik gGmbH
      • Munich, Germany
        • Not yet recruiting
        • Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
      • Rostock, Germany
        • Recruiting
        • Klinikum Südstadt Rostock Eigenbetrieb der Hanse und Universitätsstadt Rostock
      • Rüsselsheim am Main, Germany
        • Recruiting
        • Gesundheits und Pflegezentrum Ruesselsheim gGmbH
      • Speyer, Germany
        • Active, not recruiting
        • Diakonissen-Stiftungs-Krankenhaus Speyer
      • Trier, Germany
        • Recruiting
        • Klinikum Mutterhaus der Borromäerinnen gGmbH
      • Ulm, Germany
        • Not yet recruiting
        • Universitätsklinikum Ulm AöR
      • Witten, Germany
        • Recruiting
        • Marienhospital Witten
      • Worms, Germany
        • Recruiting
        • Klinikum Worms gGmbH
      • Wuppertal, Germany
        • Recruiting
        • Helios Universitätsklinikum Wuppertal
  • Ireland
      • Dublin, Ireland
        • Not yet recruiting
        • St. Vincent's University Hospital
  • Italy
      • Bologna, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
      • Genova, Italy
        • Recruiting
        • Ospedale Policlinico San Martino IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
      • Milan, Italy
        • Recruiting
        • Humanitas Research Hospital
      • Naples, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Federico II di Napoli
      • Naples, Italy
        • Recruiting
        • Istituto Nazionale Tumori Fondazione Pascale IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
      • Novara, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
      • Padua, Italy
        • Recruiting
        • Istituto Oncologico Veneto
      • Pavia, Italy
        • Recruiting
        • Istituti Clinici Scientifici Maugeri Spa Società Benefit IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
      • Pisa, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
      • Rome, Italy
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
  • Poland
      • Konin, Poland
        • Recruiting
        • Przychodnia Lekarska KOMED Roman Karaszewski
      • Krakow, Poland
        • Recruiting
        • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
      • Krakow, Poland
        • Recruiting
        • Samodzielny Publiczny Zakład Opieki Zdrowotnej (ZOZ) Szpital Uniwersytecki w Krakowie
      • Opole, Poland
        • Recruiting
        • Samodzielny Publiczny Zakład Opieki Zdrowotnej (SPOZOZ) Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
      • Poznan, Poland
        • Recruiting
        • Uniwersytecki Szpital Kliniczny w Poznaniu
      • Rzeszów, Poland
        • Recruiting
        • Centrum Medyczne Mrukmed
      • Słupsk, Poland
        • Recruiting
        • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku
      • Warsaw, Poland
        • Not yet recruiting
        • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie
      • Warsaw, Poland
        • Recruiting
        • Wojskowy Instytut Medyczny, Państwowy Instytut Badawczy
  • Romania
      • Bucharest, Romania
        • Recruiting
        • Filantropia Clinical Hospital
      • Bucharest, Romania
        • Recruiting
        • Neolife Baneasa Bucharest Medical Center
      • Cluj-Napoca, Romania
        • Recruiting
        • Institute of Oncology "Prof Dr Ion Chiricuta"
      • Timișoara, Romania
        • Recruiting
        • Oncomed SRL - Oncology Center
  • Spain
      • Albacete, Spain
        • Recruiting
        • Complejo Hospitalario Universitario de Albacete
      • Alicante, Spain
        • Recruiting
        • Hospital General Universitario Dr. Balmis
      • Badajoz, Spain
        • Recruiting
        • Hospital Universitario de Badajoz
      • Barcelona, Spain
        • Recruiting
        • Hospital del Mar
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic De Barcelona
      • Cáceres, Spain
        • Recruiting
        • Hospital San Pedro de Alcantara
      • Córdoba, Spain
        • Recruiting
        • Hospital Universitario Reina Sofía
      • El Palmar, Spain
        • Recruiting
        • Hospital Clinico Universitario Virgen de La Arrixaca
      • Fuenlabrada, Spain
        • Recruiting
        • Hospital Universitario de Fuenlabrada
      • Galdakao, Spain
        • Recruiting
        • Hospital Galdakao-Usansolo
      • Granada, Spain
        • Recruiting
        • Hospital Universitario Clínico San Cecilio
      • Jaén, Spain
        • Recruiting
        • Hospital Universitario de Jaén
      • Jerez de la Frontera, Spain
        • Recruiting
        • Hospital Universitario de Jerez de la Frontera
      • Lleida, Spain
        • Recruiting
        • Hospital Universitari Arnau de Vilanova (Lleida)
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Recruiting
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario HM Sanchinarro
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario Infanta Leonor
      • Majadahonda, Spain
        • Recruiting
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Manresa, Spain
        • Recruiting
        • Althaia, Xarxa Assistencial Universitària de Manresa
      • Murcia, Spain
        • Recruiting
        • Hospital General Universitario Morales Meseguer
      • Málaga, Spain
        • Recruiting
        • Hospital Regional Universitario de Malaga
      • Málaga, Spain
        • Recruiting
        • Hospital Clinico Universitario Virgen de la Victoria
      • Palma de Mallorca, Spain
        • Recruiting
        • Hospital Universitari Son Espases
      • San Cristóbal de La Laguna, Spain
        • Recruiting
        • Hospital Universitario de Canarias
      • San Sebastián, Spain
        • Recruiting
        • Hospital Universitario Donostia
      • Sant Cugat del Vallès, Spain
        • Recruiting
        • Hospital Universitari General de Catalunya - Grupo Quirónsalud
      • Sant Joan d'Alacant, Spain
        • Recruiting
        • Hospital Universitario San Juan de Alicante
      • Santa Cruz de Tenerife, Spain
        • Not yet recruiting
        • Hospital Universitario Nuestra Señora de Candelaria
      • Santiago de Compostela, Spain
        • Recruiting
        • Hospital Clínico Universitario de Santiago
      • Seville, Spain
        • Recruiting
        • Hospital Universitario Virgen Macarena
      • Seville, Spain
        • Recruiting
        • Hospital Universitario Virgen del Rocio
      • Toledo, Spain
        • Recruiting
        • Hospital Universitario de Toledo
      • Valencia, Spain
        • Recruiting
        • Hospital Clinico Universitario de Valencia
      • Valencia, Spain
        • Recruiting
        • Consorcio Hospital General Universitario de Valencia
      • Valencia, Spain
        • Not yet recruiting
        • Hospital Universitari Arnau de Vilanova (Valencia)
      • Zaragoza, Spain
        • Recruiting
        • Hospital Clinico Universitario Lozano Blesa
      • Zaragoza, Spain
        • Recruiting
        • Hospital Universitario Miguel Servet
  • United States
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Recruiting
        • City of Hope - Cancer Center Phoenix
        • Principal Investigator:
          • Hope Rugo, MD
        • Contact:
        • Contact:
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • Tucson Medical Center HealthCare - Tucson-Rudasill
        • Principal Investigator:
          • Aisha Ahmed, MD
        • Contact:
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope - Duarte Cancer Center
        • Principal Investigator:
          • Hope Rugo, MD
        • Contact:
        • Contact:
      • Fullerton, California, United States, 92835
        • Recruiting
        • Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Monica E Lee, MD
      • Irvine, California, United States, 92618
        • Recruiting
        • City of Hope - Orange County Lennar Foundation Cancer Center
        • Principal Investigator:
          • Hope Rugo, MD
        • Contact:
        • Contact:
      • La Jolla, California, United States, 92093
        • Recruiting
        • University of California San Diego - Moores Cancer Center
        • Contact:
        • Principal Investigator:
          • Rebecca Shatsky, MD
      • Los Angeles, California, United States, 90033
        • Active, not recruiting
        • University of Southern California - Norris Comprehensive Cancer Center
      • Palo Alto, California, United States, 74304
        • Recruiting
        • Stanford Medicine Cancer Center - Stanford Women's Cancer Center
        • Principal Investigator:
          • Fauzia Riaz, MD
        • Contact:
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Laura Huppert, MD
      • Santa Monica, California, United States, 90404
        • Recruiting
        • University of California Los Angeles - Hematology / Oncology Parkside
        • Contact:
        • Principal Investigator:
          • Aashni Master, DO
      • Whittier, California, United States, 90602
        • Recruiting
        • PIH Health Hospital - Whittier Hospital
        • Principal Investigator:
          • Lisa Wang, MD
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 80220
        • Recruiting
        • Rocky Mountain Cancer Centers
        • Principal Investigator:
          • Mabel Mardones, MD
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Yale Cancer Center - Smilow Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Michael DiGiovanna, MD, PhD
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Recruiting
        • Johns Hopkins Medicine - Kimmel Cancer Center-Sibley Memorial Hospital
        • Principal Investigator:
          • Cesar Santa-Maria, MD
        • Contact:
    • Florida
      • Miami, Florida, United States, 33146
        • Recruiting
        • University of Miami - Sylvester Comprehensive Cancer Center
        • Principal Investigator:
          • Elisa Krill-Jackson, MD
        • Contact:
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Contact:
        • Principal Investigator:
          • Aixa Soyano Muller, MD
    • Georgia
      • Newnan, Georgia, United States, 30265
        • Recruiting
        • City of Hope - Cancer Center Atlanta
        • Principal Investigator:
          • Hope Rugo, MD
        • Contact:
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University - Northwestern Memorial Hospital
        • Principal Investigator:
          • William Gradishar, MD
        • Contact:
      • Zion, Illinois, United States, 60099
        • Recruiting
        • City of Hope - Cancer Center Chicago
        • Principal Investigator:
          • Hope Rugo, MD
        • Contact:
        • Contact:
    • Maryland
      • Annapolis, Maryland, United States, 21401
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital Cancer Center
        • Principal Investigator:
          • Laura Spring, MD
        • Contact:
          • MGH Cancer Center New Patient Access Team
          • Phone Number: 877-394-5128
    • Minnesota
      • Maple Grove, Minnesota, United States, 55369
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Siteman Cancer Center - Washington University Medical Campus
        • Principal Investigator:
          • Faisal Fa'ak, MD
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Cancer Specialists
        • Contact:
        • Principal Investigator:
          • Mary Heurter Wells, MD
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • Nebraska Medicine - University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Meghana Kesireddy, MBBS
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Comprehensive Cancer Centers of Nevada
        • Principal Investigator:
          • Stephani Christensen, MD
        • Contact:
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Cooper University Health Care
        • Contact:
        • Principal Investigator:
          • Ahmed K Abou Hussein, MD
    • New York
    • Ohio
      • Cincinnati, Ohio, United States, 45211
        • Recruiting
        • Oncology Hematology Care
        • Contact:
        • Principal Investigator:
          • Patrick Ward, MD, PhD
    • Oregon
      • Tigard, Oregon, United States, 97223
        • Recruiting
        • Compass Oncology - Northwest Cancer Specialists
        • Principal Investigator:
          • Jay Andersen, MD
        • Contact:
    • Pennsylvania
      • Meadowbrook, Pennsylvania, United States, 19046
        • Recruiting
        • Redeemer Health - Holy Redeemer Hospital
        • Contact:
        • Principal Investigator:
          • Danny Markabawi, MD
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Sidney Kimmel Comprehensive Cancer Center - Thomas Jefferson University Hospital
        • Principal Investigator:
          • Maysa Abu-Khalaf, MD
        • Contact:
    • Texas
      • Austin, Texas, United States, 78745
        • Recruiting
        • Texas Oncology - Austin
        • Contact:
        • Principal Investigator:
          • Kathryn Hudson, MD
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Texas Oncology - Baylor Charles A. Sammons Cancer Center
        • Principal Investigator:
          • Cynthia Osborne, MD
        • Contact:
      • Dallas, Texas, United States, 75390
        • Recruiting
        • The University of Texas Southwestern Medical Center
        • Principal Investigator:
          • Nisha Unni, MD
        • Contact:
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Texas Oncology - Dallas Presbyterian Hospital
        • Principal Investigator:
          • Cynthia Osborne, MD
        • Contact:
      • Houston, Texas, United States, 77057
        • Recruiting
        • Baylor College of Medicine - Dan L. Duncan Comprehensive Cancer Center
        • Principal Investigator:
          • Mothaffar Rimawi, MD
        • Contact:
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Texas Oncology - San Antonio
        • Principal Investigator:
          • Emmalind Aponte, MD
        • Contact:
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • The University of Texas Health Sciences Center at San Antonio - Mays Cancer Center
        • Principal Investigator:
          • Virginia Kaklamani, MD
        • Contact:
      • Sugar Land, Texas, United States, 77479
      • Tyler, Texas, United States, 75702
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah - Huntsman Cancer Institute
        • Contact:
        • Principal Investigator:
          • Mei Wei, MD
    • Virginia
      • Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • HLA-A*02-positive, unless being enrolled in the third non-HLA-A*02 arm
  • Histologically confirmed diagnosis of HER2/neu positive primary breast cancer for all tumors biopsied (multifocal, multicentric, or synchronous contralateral disease)
  • Completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast cancer therapy
  • Stage I, II, or III at presentation with pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes (residual disease) at surgery following completion of neoadjuvant therapy -OR- Stage III at presentation with pathologic complete response (pCR) at surgery following completion of neoadjuvant therapy
  • The subject can begin study therapy within one year of completion of adjuvant trastuzumab-based therapy and any other standard therapies, but, study therapy can be administered concurrently with endocrine therapy.
  • No clinical evidence of residual or persistent breast cancer per treating physician assessment
  • ECOG 0-2
  • Adequate organ function
  • Negative pregnancy test or evidence of post-menopausal status
  • If of childbearing potential, willing to use a form of highly effective contraception
  • Subject must both reside in and have been treated for their cancer in the country in which the clinical site is located.

Exclusion Criteria:

  • Stage IV cancer or metastatic breast cancer at any time
  • Inflammatory breast cancer
  • Receiving other investigational agents
  • Receiving chemotherapy
  • Requiring long-term systemic treatment with corticosteroids or other immunosuppressive therapy
  • History of immunodeficiency or active autoimmune disease
  • A history of serious allergic reactions, including anaphylaxis, to human granulocyte-macrophage colony-stimulating factors such as sargramostim, yeast-derived products, or any component of the investigational product
  • Other malignancies except adequately treated in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin
  • Active infection
  • Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment. Note: Subjects on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 0.9% Normal Saline
0.9% normal saline in HLA-A*02 positive and HER2/neu positive subjects administered intradermally every month for first 6 months then every 6 months for next 2.5 years (11 intradermal injections over 3 years)
Biological: Placebo
0.9% Normal Saline
Experimental: GLSI-100
GLSI-100 immunotherapy in HLA-A*02 positive and HER2/neu positive subjects administered intradermally every month for first 6 months then every 6 months for next 2.5 years (11 intradermal injections over 3 years)
Biological: GLSI-100
500 mcg/mL GP2 and 125 mcg/mL GM-CSF
Experimental: GLSI-100, Open-label
Open-label arm: GLSI-100 immunotherapy in non-HLA-A*02 positive and HER2/neu positive subjects administered intradermally every month for first 6 months then every 6 months for next 2.5 years (11 intradermal injections over 3 years)
Biological: GLSI-100
500 mcg/mL GP2 and 125 mcg/mL GM-CSF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Invasive Breast Cancer-free Survival (IBCFS)
Time Frame: Median 4 years of follow-up (interim analysis planned)
IBCFS is defined as the time from the first dose of study medication until the date of ipsilateral invasive breast cancer recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or any cause mortality.
Median 4 years of follow-up (interim analysis planned)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Invasive Disease-free Survival (IDFS)
Time Frame: Median 4 years of follow-up (interim analysis planned)
IDFS is defined as the time from the first dose of study medication until the date of ipsilateral invasive breast cancer recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, or any cause mortality.
Median 4 years of follow-up (interim analysis planned)
Distant Disease-free Survival (DDFS)
Time Frame: Median 4 years of follow-up (interim analysis planned)
DDFS will be defined as the time from the first dose of study medication to the time of distant disease recurrence or death.
Median 4 years of follow-up (interim analysis planned)
Overall Survival
Time Frame: Median 4 years of follow-up (interim analysis planned)
Overall survival will be defined as the time from the first dose of study medication until death from any cause.
Median 4 years of follow-up (interim analysis planned)
Quality of Life Questionnaire Core 30 (QLQ-C30)
Time Frame: Baseline and 36 months
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
Baseline and 36 months
Quality of Life FACT-GP5
Time Frame: Baseline and 36 months
FACT-GP5 to assess global side effect impact
Baseline and 36 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune Response Measurements
Time Frame: Screening, Baseline, Month 4, Month 6, Month 12, Month 13, Month 18, Month 24, Month 25, Month 30, Month 36, Month 37, Month 42, Month 48
Immune response will be measured by Delayed-Type Hypersensitivity (DTH) tests and immunologic assays.
Screening, Baseline, Month 4, Month 6, Month 12, Month 13, Month 18, Month 24, Month 25, Month 30, Month 36, Month 37, Month 42, Month 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Greenwich LifeSciences, Inc.

Investigators

  • Principal Investigator: Mothaffar F Rimawi, MD, Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 31, 2022

First Submitted That Met QC Criteria

January 31, 2022

First Posted (Actual)

February 10, 2022

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLSI-21-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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