Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
NCT ID: NCT05232916
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
750 participants
INTERVENTIONAL
2022-08-11
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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)
Placebo
0.9% Normal Saline
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)
GLSI-100
500 mcg/mL GP2 and 125 mcg/mL GM-CSF
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)
GLSI-100
500 mcg/mL GP2 and 125 mcg/mL GM-CSF
Interventions
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Placebo
0.9% Normal Saline
GLSI-100
500 mcg/mL GP2 and 125 mcg/mL GM-CSF
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
100 Years
ALL
No
Sponsors
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Greenwich LifeSciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mothaffar F Rimawi, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Tucson Medical Center HealthCare - Tucson-Rudasill
Tucson, Arizona, United States
Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center
Fullerton, California, United States
University of California San Diego - Moores Cancer Center
La Jolla, California, United States
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, United States
Stanford Medicine Cancer Center - Stanford Women's Cancer Center
Palo Alto, California, United States
University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
University of California Los Angeles - Hematology / Oncology Parkside
Santa Monica, California, United States
PIH Health Hospital - Whittier Hospital
Whittier, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Yale Cancer Center - Smilow Cancer Hospital
New Haven, Connecticut, United States
Johns Hopkins Medicine - Kimmel Cancer Center-Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northwestern University - Northwestern Memorial Hospital
Chicago, Illinois, United States
Maryland Oncology Hematology
Annapolis, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Minnesota Oncology
Maple Grove, Minnesota, United States
Siteman Cancer Center - Washington University Medical Campus
St Louis, Missouri, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Nebraska Medicine - University of Nebraska Medical Center
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States
Cooper University Health Care
Camden, New Jersey, United States
New York Oncology Hematology
Albany, New York, United States
New York-Presbyterian - Columbia University Irving Medical Center
New York, New York, United States
Stony Brook University Cancer Center
Stony Brook, New York, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
Compass Oncology - Northwest Cancer Specialists
Tigard, Oregon, United States
Redeemer Health - Holy Redeemer Hospital
Meadowbrook, Pennsylvania, United States
Sidney Kimmel Comprehensive Cancer Center - Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Texas Oncology - Austin
Austin, Texas, United States
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine - Dan L. Duncan Comprehensive Cancer Center
Houston, Texas, United States
The University of Texas Health Sciences Center at San Antonio - Mays Cancer Center
San Antonio, Texas, United States
Texas Oncology - San Antonio
San Antonio, Texas, United States
Texas Oncology - Gulf Coast
Sugar Land, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Sainte-Catherine - Institut du Cancer Avignon-Provence (ICAP)
Avignon, , France
Clinique Pasteur-Lanroze
Brest, , France
Centre François Baclesse (CLCC)
Caen, , France
Pôle Santé Léonard De Vinci
Chambray-lès-Tours, , France
Centre Hospitalier de Cholet
Cholet, , France
Centre Hospitalier Alpes Leman
Contamine-sur-Arve, , France
Centre Léon Bérard
Lyon, , France
Hôpital Privé du Confluent
Nantes, , France
Centre Hospitalier Privé Sainte-Marie Osny
Osny, , France
Institut Curie
Paris, , France
Hospices Civils de Lyon
Pierre-Bénite, , France
Hôpital NOVO (Nord-Ouest Val-d'Oise)
Pontoise, , France
Institut Jean Godinot (CLCC)
Reims, , France
Institut Curie
Saint-Cloud, , France
Centre Hospitalier Privé Saint-Grégoire
Saint-Grégoire, , France
Centre Hospitalier Universitaire de Saint-Étienne
Saint-Priest-en-Jarez, , France
Institut de cancérologie Strasbourg Europe
Strasbourg, , France
Hôpital Privé Drôme Ardèche
Valence, , France
Hôpital Robert Schuman
Vantoux, , France
Institut Gustave Roussy
Villejuif, , France
Haematologie-Onkologie im Zentrum MVZ GmbH
Augsburg, , Germany
Klinikum Bayreuth GmbH
Bayreuth, , Germany
DBZ Onkologie GmbH
Berlin, , Germany
Helios Klinikum Berlin-Buch GmbH
Berlin, , Germany
Marienhospital Bottrop gGmbH
Bottrop, , Germany
Evangelisches Diakonie-Krankenhaus gGmbH
Bremen, , Germany
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Städtisches Klinikum Dessau
Dessau, , Germany
St.-Johannes Hospital Dortmund
Dortmund, , Germany
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Dresden, , Germany
MVZ Medical Center Duesseldorf GmbH
Düsseldorf, , Germany
Studienzentrale für das MVZ Eggenfelden e.K.
Eggenfelden, , Germany
Evangelisches Kliniken Essen-Mitte gGmbH
Essen, , Germany
Klinikum Frankfurt Höchst GmbH
Frankfurt, , Germany
Praxis für Interdisziplinäre Onkologie und Haematologie GbR
Freiburg im Breisgau, , Germany
Helios Klinikum Gifhorn GmbH
Gifhorn, , Germany
Universitätsmedizin Göttingen
Göttingen, , Germany
Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
Halle, , Germany
Mammazentrum Hamburg MVZ GbR
Hamburg, , Germany
Gynäkologische Praxisklinik Hamburg-Harburg
Harburg, , Germany
National Center For Tumor Diseases (NCT) Heidelberg
Heidelberg, , Germany
Elisabeth Krankenhaus GmbH
Kassel, , Germany
MVZ GynKrefeld GmbH
Krefeld, , Germany
Gemeinschaftspraxis für Hämatologie und Onkologie Langen
Langen, , Germany
Studienzentrum UnterEms Leer
Leer, , Germany
RKH Klinken Ludwigsburg-Bietigheim gGmbH
Ludwigsburg, , Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Mainz, , Germany
Heidelberg University
Mannheim, , Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Munich, , Germany
München Klinik gGmbH
Munich, , Germany
Klinikum Südstadt Rostock Eigenbetrieb der Hanse und Universitätsstadt Rostock
Rostock, , Germany
Gesundheits und Pflegezentrum Ruesselsheim gGmbH
Rüsselsheim am Main, , Germany
Diakonissen-Stiftungs-Krankenhaus Speyer
Speyer, , Germany
Klinikum Mutterhaus der Borromäerinnen gGmbH
Trier, , Germany
Universitätsklinikum Ulm AöR
Ulm, , Germany
Marienhospital Witten
Witten, , Germany
Klinikum Worms gGmbH
Worms, , Germany
Helios Universitätsklinikum Wuppertal
Wuppertal, , Germany
St. Vincent's University Hospital
Dublin, , Ireland
Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
Bologna, , Italy
Ospedale Policlinico San Martino IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
Genova, , Italy
Humanitas Research Hospital
Milan, , Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, , Italy
Istituto Nazionale Tumori Fondazione Pascale IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
Naples, , Italy
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
Novara, , Italy
Istituto Oncologico Veneto
Padua, , Italy
Istituti Clinici Scientifici Maugeri Spa Società Benefit IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
Pavia, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
Rome, , Italy
Przychodnia Lekarska KOMED Roman Karaszewski
Konin, , Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej (ZOZ) Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow, , Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej (SPOZOZ) Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
Opole, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, , Poland
Centrum Medyczne MrukMed
Rzeszów, , Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku
Słupsk, , Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie
Warsaw, , Poland
Wojskowy Instytut Medyczny, Państwowy Instytut Badawczy
Warsaw, , Poland
Filantropia Clinical Hospital
Bucharest, , Romania
Neolife Baneasa Bucharest Medical Center
Bucharest, , Romania
Institute of Oncology "Prof Dr Ion Chiricuta"
Cluj-Napoca, , Romania
Oncomed SRL - Oncology Center
Timișoara, , Romania
Complejo Hospitalario Universitario de Albacete
Albacete, , Spain
Hospital General Universitario Dr. Balmis
Alicante, , Spain
Hospital Universitario de Badajoz
Badajoz, , Spain
Hospital Clínic De Barcelona
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital San Pedro de Alcántara
Cáceres, , Spain
Hospital Universitario Reina Sofía
Córdoba, , Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, , Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, , Spain
Hospital Galdakao-Usansolo
Galdakao, , Spain
Hospital Universitario Clínico San Cecilio
Granada, , Spain
Hospital Universitario de Jaén
Jaén, , Spain
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, , Spain
Hospital Universitari Arnau de Vilanova (Lleida)
Lleida, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
Hospital Universitario Infanta Leonor
Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, , Spain
Althaia, Xarxa Assistencial Universitària de Manresa
Manresa, , Spain
Hospital Clínico Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Hospital General Universitario Morales Meseguer
Murcia, , Spain
Hospital Universitari Son Espases
Palma de Mallorca, , Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, , Spain
Hospital Universitario Donostia
San Sebastián, , Spain
Hospital Universitari General de Catalunya - Grupo Quirónsalud
Sant Cugat del Vallès, , Spain
Hospital Universitario San Juan de Alicante
Sant Joan d'Alacant, , Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, , Spain
Hospital Clínico Universitario de Santiago
Santiago de Compostela, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario de Toledo
Toledo, , Spain
Consorcio Hospital General Universitario de Valencia
Valencia, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital Universitari Arnau de Vilanova (Valencia)
Valencia, , Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Countries
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Central Contacts
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Facility Contacts
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Role: primary
MGH Cancer Center New Patient Access Team
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
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GLSI-21-01
Identifier Type: -
Identifier Source: org_study_id
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