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

Phase 3

Recruiting

• Conditions: Breast Cancer
• Interventions: Biological: Placebo; Biological: GLSI-100

• Registration Number: NCT05232916
• Lead Sponsor: Greenwich LifeSciences, Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-10
• Study Start: 2022-08-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 598

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
• 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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.9% Normal Saline	Placebo	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)
GLSI-100	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, Open-label	GLSI-100	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)

Primary Outcome Measures

Name	Time	Method
Invasive Breast Cancer-free Survival (IBCFS)	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.

Secondary Outcome Measures

Name	Time	Method
Invasive Disease-free Survival (IDFS)	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.
Distant Disease-free Survival (DDFS)	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.
Overall Survival	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.
Quality of Life Questionnaire Core 30 (QLQ-C30)	Baseline and 36 months	European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
Quality of Life FACT-GP5	Baseline and 36 months	FACT-GP5 to assess global side effect impact

Trial Locations

Locations (149)

Hospital Universitario Donostia; 🇪🇸 San Sebastián, Spain

Hospital Universitari General de Catalunya - Grupo Quirónsalud; 🇪🇸 Sant Cugat Del Vallès, Spain

Hospital Universitario Nuestra Señora de Candelaria; 🇪🇸 Santa Cruz De Tenerife, Spain

Centre Hospitalier Privé Saint-Grégoire; 🇫🇷 Saint-Grégoire, France

Centre Eugène Marquis (CLCC); 🇫🇷 Rennes, France

Arizona Oncology Associates; 🇺🇸 Tucson, Arizona, United States

Providence St. Jude Medical Center; 🇺🇸 Fullerton, California, United States

University of Southern California - Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Stanford University 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

Torrance Memorial Physicians Network; 🇺🇸 Torrance, California, United States

PIH Health Hospital - Whittier; 🇺🇸 Whittier, California, United States

Rocky Mountain Cancer Centers; 🇺🇸 Denver, Colorado, United States

Yale University Cancer Center; 🇺🇸 New Haven, Connecticut, United States

Johns Hopkins University - Sibley Memorial Hospital; 🇺🇸 Washington, District of Columbia, United States

University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Northwestern University - Feinberg School of Medicine (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 Clinic; 🇺🇸 Maple Grove, Minnesota, United States

Washington University School of Medicine - Siteman Cancer Center; 🇺🇸 Saint Louis, Missouri, United States

Nebraska Cancer Specialists - Legacy; 🇺🇸 Omaha, Nebraska, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Comprehensive Cancer Centers of Nevada; 🇺🇸 Henderson, Nevada, United States

New York Oncology Hematology; 🇺🇸 Clifton Park, New York, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Stony Brook University Cancer Center; 🇺🇸 Stony Brook, New York, United States

Oncology Hematology Care Clinical Trials; 🇺🇸 Cincinnati, Ohio, United States

Northwest Cancer Specialists - Compass Oncology; 🇺🇸 Tigard, Oregon, United States

Redeemer Health; 🇺🇸 Meadowbrook, Pennsylvania, United States

Thomas Jefferson University - Sidney Kimmel Cancer Center; 🇺🇸 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; 🇺🇸 Houston, Texas, United States

Texas Oncology - San Antonio; 🇺🇸 San Antonio, Texas, United States

Texas Oncology - Gulf Coast; 🇺🇸 Sugar Land, Texas, United States

Texas Oncology - Northeast Texas; 🇺🇸 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

Centre Hospitalier Simone Veil de Beauvais; 🇫🇷 Beauvais, France

Clinique Pasteur-Lanroze; 🇫🇷 Brest, France

Centre François Baclesse (CLCC); 🇫🇷 Caen, France

Pôle Santé République - ELSAN; 🇫🇷 Clermont-Ferrand, France

Hôpital privé Drôme Ardèche; 🇫🇷 Guilherand-Granges, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Centre Hospitalier Privé Sainte-Marie Osny; 🇫🇷 Osny, France

Institut Curie; 🇫🇷 Saint-Cloud, France

Hôpital NOVO (Nord-Ouest Val-d'Oise); 🇫🇷 Pontoise, France

Centre Hospitalier Intercommunal de Cornouaille Quimper Concarneau (CHIC); 🇫🇷 Quimper, France

Institut Godinot (CLCC); 🇫🇷 Reims, France

Centre Hospitalier Universitaire de Saint-Étienne; 🇫🇷 Saint-Priest-en-Jarez, France

Institut de cancérologie Strasbourg Europe; 🇫🇷 Strasbourg, France

Hôpital Robert Schuman; 🇫🇷 Vantoux, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Hämatologie-Onkologie im Zentrum MVZ; 🇩🇪 Augsburg, Germany

Klinikum Bayreuth; 🇩🇪 Bayreuth, Germany

DBZ Onkologie; 🇩🇪 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

Universitätsklinikum Carl Gustav Carus Dresden; 🇩🇪 Dresden, Germany

MVZ Medical Center Düsseldorf; 🇩🇪 Düsseldorf, Germany

Studienzentrale für das MVZ Eggenfelden e.K.; 🇩🇪 Eggenfelden, Germany

Kliniken Essen-Mitte; 🇩🇪 Essen, Germany

Klinikum Frankfurt Höchst; 🇩🇪 Frankfurt, Germany

Praxis für interdisziplinäre Onkologie & Hämatologie; 🇩🇪 Freiburg, Germany

Helios Klinikum Gifhorn; 🇩🇪 Gifhorn, Germany

Universitätsmedizin Göttingen; 🇩🇪 Göttingen, Germany

Krankenhaus St. Elisabeth und St. Barbara Halle (Saale); 🇩🇪 Halle, Germany

Gynäkologische Praxisklinik Hamburg Harburg; 🇩🇪 Hamburg-Harburg, Germany

Mammazentrum Hamburg; 🇩🇪 Hamburg, Germany

National Center for Tumor Diseases (NCT) Heidelberg; 🇩🇪 Heidelberg, Germany

Elisabeth-Krankenhaus Kassel; 🇩🇪 Kassel, Germany

MVZ GynKrefeld GmbH; 🇩🇪 Krefeld, Germany

Gemeinschaftspraxis für Hämatologie und Onkologie; 🇩🇪 Langen, Germany

MVM Medizinische Verwaltungs- und Managementgesellschaft; 🇩🇪 Leer, Germany

RKH Kliniken Ludwigsburg-Bietigheim; 🇩🇪 Ludwigsburg, Germany

Universitätsmedizin der Johannes Gutenberg Universität Mainz KöR; 🇩🇪 Mainz, Germany

Universität Heidelberg; 🇩🇪 Mannheim, Germany

Klinikum rechts der Isar der TU Muenchen AoeR; 🇩🇪 Munich, Germany

München Klinik; 🇩🇪 Munich, Germany

Klinikum Südstadt Rostock; 🇩🇪 Rostock, Germany

Gesundheits- und Pflegezentrum Rüsselsheim; 🇩🇪 Rüsselsheim, Germany

Diakonissen-Stiftungs-Krankenhaus Speyer (Brustzentrum); 🇩🇪 Speyer, Germany

Klinikum Mutterhaus der Borromäerinnen; 🇩🇪 Trier, Germany

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany

Marien Hospital Witten; 🇩🇪 Witten, Germany

Klinikum Worms; 🇩🇪 Worms, Germany

Helios Universitätsklinikum Wuppertal; 🇩🇪 Wuppertal, Germany

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; 🇮🇹 Padova, Italy

Istituti Clinici Scientifici Maugeri Spa Società Benefit IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico); 🇮🇹 Pavia, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico); 🇮🇹 Rome, Italy

Samodzielny Publiczny Zakład Opieki Zdrowotnej (ZOZ) Szpital Uniwersytecki w Krakowie; 🇵🇱 Kraków, Poland

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie; 🇵🇱 Kraków, Poland

Samodzielny Publiczny Zakład Opieki Zdrowotnej (SPOZOZ) Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu; 🇵🇱 Opole, Poland

Uniwersytecki Szpital Kliniczny w Poznaniu; 🇵🇱 Poznań, Poland

Centrum Medyczne MrukMed; 🇵🇱 Rzeszów, Poland

Zachodniopomorskie Centrum Onkologii; 🇵🇱 Szczecin, Poland

Instytut Centrum Zdrowia Matki Polki (ICZMP); 🇵🇱 Łódź, Poland

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 Universitario de Canarias; 🇪🇸 La Laguna, 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 General Universitario Morales Meseguer; 🇪🇸 Murcia, Spain

Hospital Regional Universitario de Malaga; 🇪🇸 Málaga, Spain

Hospital Universitari Son Espases; 🇪🇸 Palma De Mallorca, Spain

Hospital Universitario San Juan de Alicante; 🇪🇸 San Juan De Alicante, Spain

Hospital Clínico Universitario de Santiago; 🇪🇸 Santiago de Compostela, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain

Hospital Universitario de Toledo; 🇪🇸 Toledo, Spain

Consorcio Hospital General Universitario de Valencia; 🇪🇸 Valencia, Spain

Fundación Instituto Valenciano de Oncología; 🇪🇸 Valencia, Spain

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitari Arnau de Vilanova (Valencia); 🇪🇸 Valencia, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain