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

NCT05232916 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: GLSI-21-01
• Study Type: interventional
• Target: 750
• Locations: 8 countries
• Sites: 166

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.

Conditions

Breast Cancer

Keywords

HER2/neu positive; Residual disease; pCR; Extended adjuvant; GP2; Immunotherapy; HLA type

Outcome Measures

Primary Outcomes (1)

• Invasive Breast Cancer-free Survival (IBCFS)

  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 Outcomes (5)

• Invasive Disease-free Survival (IDFS)

  Median 4 years of follow-up (interim analysis planned)

• Distant Disease-free Survival (DDFS)

  Median 4 years of follow-up (interim analysis planned)

• Overall Survival

  Median 4 years of follow-up (interim analysis planned)

• Quality of Life Questionnaire Core 30 (QLQ-C30)

  Baseline and 36 months

• Quality of Life FACT-GP5

  Baseline and 36 months

Other Outcomes (1)

• Immune Response Measurements

  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

Study Arms (3)

0.9% Normal Saline

PLACEBO COMPARATOR

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

GLSI-100

EXPERIMENTAL

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

GLSI-100, Open-label

EXPERIMENTAL

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

Interventions

Placebo BIOLOGICAL

0.9% Normal Saline

0.9% Normal Saline

GLSI-100 BIOLOGICAL

500 mcg/mL GP2 and 125 mcg/mL GM-CSF

GLSI-100; GLSI-100, Open-label

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Greenwich LifeSciences, Inc.: lead

Study Sites (166)

City of Hope - Cancer Center Phoenix

Goodyear, Arizona, 85338, United States

RECRUITING

Tucson Medical Center HealthCare - Tucson-Rudasill

Tucson, Arizona, 85704, United States

RECRUITING

City of Hope - Duarte Cancer Center

Duarte, California, 91010, United States

RECRUITING

Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center

Fullerton, California, 92835, United States

RECRUITING

City of Hope - Orange County Lennar Foundation Cancer Center

Irvine, California, 92618, United States

RECRUITING

University of California San Diego - Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

University of Southern California - Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

ACTIVE NOT RECRUITING

Stanford Medicine Cancer Center - Stanford Women's Cancer Center

Palo Alto, California, 74304, United States

RECRUITING

University of California San Francisco - Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94158, United States

RECRUITING

University of California Los Angeles - Hematology / Oncology Parkside

Santa Monica, California, 90404, United States

RECRUITING

PIH Health Hospital - Whittier Hospital

Whittier, California, 90602, United States

RECRUITING

Rocky Mountain Cancer Centers

Denver, Colorado, 80220, United States

RECRUITING

Yale Cancer Center - Smilow Cancer Hospital

New Haven, Connecticut, 06511, United States

RECRUITING

Johns Hopkins Medicine - Kimmel Cancer Center-Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

RECRUITING

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, 33146, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

City of Hope - Cancer Center Atlanta

Newnan, Georgia, 30265, United States

RECRUITING

Northwestern University - Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

City of Hope - Cancer Center Chicago

Zion, Illinois, 60099, United States

RECRUITING

Maryland Oncology Hematology

Annapolis, Maryland, 21401, United States

RECRUITING

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

RECRUITING

Minnesota Oncology

Maple Grove, Minnesota, 55369, United States

RECRUITING

Siteman Cancer Center - Washington University Medical Campus

St Louis, Missouri, 63110, United States

RECRUITING

Nebraska Cancer Specialists

Omaha, Nebraska, 68114, United States

RECRUITING

Nebraska Medicine - University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, 89052, United States

RECRUITING

Cooper University Health Care

Camden, New Jersey, 08103, United States

RECRUITING

New York Oncology Hematology

Albany, New York, 12065, United States

RECRUITING

New York-Presbyterian - Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Stony Brook University Cancer Center

Stony Brook, New York, 11794, United States

RECRUITING

Oncology Hematology Care

Cincinnati, Ohio, 45211, United States

RECRUITING

Compass Oncology - Northwest Cancer Specialists

Tigard, Oregon, 97223, United States

RECRUITING

Redeemer Health - Holy Redeemer Hospital

Meadowbrook, Pennsylvania, 19046, United States

RECRUITING

Sidney Kimmel Comprehensive Cancer Center - Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Texas Oncology - Austin

Austin, Texas, 78745, United States

RECRUITING

Texas Oncology - Dallas Presbyterian Hospital

Dallas, Texas, 75231, United States

RECRUITING

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

RECRUITING

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Baylor College of Medicine - Dan L. Duncan Comprehensive Cancer Center

Houston, Texas, 77057, United States

RECRUITING

The University of Texas Health Sciences Center at San Antonio - Mays Cancer Center

San Antonio, Texas, 78229, United States

RECRUITING

Texas Oncology - San Antonio

San Antonio, Texas, 78240, United States

RECRUITING

Texas Oncology - Gulf Coast

Sugar Land, Texas, 77479, United States

RECRUITING

Texas Oncology - Tyler

Tyler, Texas, 75702, United States

RECRUITING

University of Utah - Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

RECRUITING

Sainte-Catherine - Institut du Cancer Avignon-Provence (ICAP)

Avignon, France

RECRUITING

Clinique Pasteur-Lanroze

Brest, France

RECRUITING

Centre François Baclesse (CLCC)

Caen, France

RECRUITING

Pôle Santé Léonard De Vinci

Chambray-lès-Tours, France

NOT YET RECRUITING

Centre Hospitalier de Cholet

Cholet, France

NOT YET RECRUITING

Centre Hospitalier Alpes Leman

Contamine-sur-Arve, France

NOT YET RECRUITING

Centre Léon Bérard

Lyon, France

RECRUITING

Hôpital Privé du Confluent

Nantes, France

NOT YET RECRUITING

Centre Hospitalier Privé Sainte-Marie Osny

Osny, France

RECRUITING

Institut Curie

Paris, France

RECRUITING

Hospices Civils de Lyon

Pierre-Bénite, France

NOT YET RECRUITING

Hôpital NOVO (Nord-Ouest Val-d'Oise)

Pontoise, France

RECRUITING

Institut Jean Godinot (CLCC)

Reims, France

RECRUITING

Institut Curie

Saint-Cloud, France

RECRUITING

Centre Hospitalier Privé Saint-Grégoire

Saint-Grégoire, France

RECRUITING

Centre Hospitalier Universitaire de Saint-Étienne

Saint-Priest-en-Jarez, France

RECRUITING

Institut de cancérologie Strasbourg Europe

Strasbourg, France

RECRUITING

Hôpital Privé Drôme Ardèche

Valence, France

RECRUITING

Hôpital Robert Schuman

Vantoux, France

RECRUITING

Institut Gustave Roussy

Villejuif, France

RECRUITING

Haematologie-Onkologie im Zentrum MVZ GmbH

Augsburg, Germany

RECRUITING

Klinikum Bayreuth GmbH

Bayreuth, Germany

NOT YET RECRUITING

DBZ Onkologie GmbH

Berlin, Germany

NOT YET RECRUITING

Helios Klinikum Berlin-Buch GmbH

Berlin, Germany

RECRUITING

Marienhospital Bottrop gGmbH

Bottrop, Germany

RECRUITING

Evangelisches Diakonie-Krankenhaus gGmbH

Bremen, Germany

RECRUITING

Klinikum Chemnitz gGmbH

Chemnitz, Germany

NOT YET RECRUITING

Städtisches Klinikum Dessau

Dessau, Germany

RECRUITING

St.-Johannes Hospital Dortmund

Dortmund, Germany

ACTIVE NOT RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR

Dresden, Germany

NOT YET RECRUITING

MVZ Medical Center Duesseldorf GmbH

Düsseldorf, Germany

RECRUITING

Studienzentrale für das MVZ Eggenfelden e.K.

Eggenfelden, Germany

RECRUITING

Evangelisches Kliniken Essen-Mitte gGmbH

Essen, Germany

RECRUITING

Klinikum Frankfurt Höchst GmbH

Frankfurt, Germany

RECRUITING

Praxis für Interdisziplinäre Onkologie und Haematologie GbR

Freiburg im Breisgau, Germany

RECRUITING

Helios Klinikum Gifhorn GmbH

Gifhorn, Germany

RECRUITING

Universitätsmedizin Göttingen

Göttingen, Germany

NOT YET RECRUITING

Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH

Halle, Germany

RECRUITING

Mammazentrum Hamburg MVZ GbR

Hamburg, Germany

RECRUITING

Gynäkologische Praxisklinik Hamburg-Harburg

Harburg, Germany

RECRUITING

National Center For Tumor Diseases (NCT) Heidelberg

Heidelberg, Germany

RECRUITING

Elisabeth Krankenhaus GmbH

Kassel, Germany

RECRUITING

MVZ GynKrefeld GmbH

Krefeld, Germany

NOT YET RECRUITING

Gemeinschaftspraxis für Hämatologie und Onkologie Langen

Langen, Germany

ACTIVE NOT RECRUITING

Studienzentrum UnterEms Leer

Leer, Germany

ACTIVE NOT RECRUITING

RKH Klinken Ludwigsburg-Bietigheim gGmbH

Ludwigsburg, Germany

RECRUITING

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

Mainz, Germany

NOT YET RECRUITING

Heidelberg University

Mannheim, Germany

NOT YET RECRUITING

Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)

Munich, Germany

NOT YET RECRUITING

München Klinik gGmbH

Munich, Germany

NOT YET RECRUITING

Klinikum Südstadt Rostock Eigenbetrieb der Hanse und Universitätsstadt Rostock

Rostock, Germany

RECRUITING

Gesundheits und Pflegezentrum Ruesselsheim gGmbH

Rüsselsheim am Main, Germany

RECRUITING

Diakonissen-Stiftungs-Krankenhaus Speyer

Speyer, Germany

ACTIVE NOT RECRUITING

Klinikum Mutterhaus der Borromäerinnen gGmbH

Trier, Germany

RECRUITING

Universitätsklinikum Ulm AöR

Ulm, Germany

NOT YET RECRUITING

Marienhospital Witten

Witten, Germany

RECRUITING

Klinikum Worms gGmbH

Worms, Germany

RECRUITING

Helios Universitätsklinikum Wuppertal

Wuppertal, Germany

RECRUITING

St. Vincent's University Hospital

Dublin, Ireland

NOT YET RECRUITING

Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)

Bologna, Italy

RECRUITING

Ospedale Policlinico San Martino IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)

Genova, Italy

RECRUITING

Humanitas Research Hospital

Milan, 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)

Naples, Italy

RECRUITING

Azienda Ospedaliero Universitaria Maggiore della Carità di Novara

Novara, Italy

RECRUITING

Istituto Oncologico Veneto

Padua, Italy

RECRUITING

Istituti Clinici Scientifici Maugeri Spa Società Benefit IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)

Pavia, Italy

RECRUITING

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)

Rome, Italy

RECRUITING

Przychodnia Lekarska KOMED Roman Karaszewski

Konin, Poland

RECRUITING

Samodzielny Publiczny Zakład Opieki Zdrowotnej (ZOZ) Szpital Uniwersytecki w Krakowie

Krakow, Poland

RECRUITING

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

Krakow, Poland

RECRUITING

Samodzielny Publiczny Zakład Opieki Zdrowotnej (SPOZOZ) Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu

Opole, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Poland

RECRUITING

Centrum Medyczne MrukMed

Rzeszów, Poland

RECRUITING

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku

Słupsk, Poland

RECRUITING

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie

Warsaw, Poland

NOT YET RECRUITING

Wojskowy Instytut Medyczny, Państwowy Instytut Badawczy

Warsaw, Poland

RECRUITING

Filantropia Clinical Hospital

Bucharest, Romania

RECRUITING

Neolife Baneasa Bucharest Medical Center

Bucharest, Romania

RECRUITING

Institute of Oncology "Prof Dr Ion Chiricuta"

Cluj-Napoca, Romania

RECRUITING

Oncomed SRL - Oncology Center

Timișoara, Romania

RECRUITING

Complejo Hospitalario Universitario de Albacete

Albacete, Spain

RECRUITING

Hospital General Universitario Dr. Balmis

Alicante, Spain

RECRUITING

Hospital Universitario de Badajoz

Badajoz, Spain

RECRUITING

Hospital Clínic De Barcelona

Barcelona, Spain

RECRUITING

Hospital del Mar

Barcelona, Spain

RECRUITING

Hospital San Pedro de Alcántara

Cáceres, Spain

RECRUITING

Hospital Universitario Reina Sofía

Córdoba, Spain

RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Spain

RECRUITING

Hospital Universitario de Fuenlabrada

Fuenlabrada, Spain

RECRUITING

Hospital Galdakao-Usansolo

Galdakao, Spain

RECRUITING

Hospital Universitario Clínico San Cecilio

Granada, Spain

RECRUITING

Hospital Universitario de Jaén

Jaén, Spain

RECRUITING

Hospital Universitario de Jerez de la Frontera

Jerez de la Frontera, Spain

RECRUITING

Hospital Universitari Arnau de Vilanova (Lleida)

Lleida, Spain

RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Spain

RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

RECRUITING

Hospital Universitario HM Sanchinarro

Madrid, Spain

RECRUITING

Hospital Universitario Infanta Leonor

Madrid, Spain

NOT YET RECRUITING

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain

RECRUITING

Althaia, Xarxa Assistencial Universitària de Manresa

Manresa, Spain

RECRUITING

Hospital Clínico Universitario Virgen de la Victoria

Málaga, Spain

RECRUITING

Hospital Regional Universitario de Malaga

Málaga, Spain

RECRUITING

Hospital General Universitario Morales Meseguer

Murcia, Spain

RECRUITING

Hospital Universitari Son Espases

Palma de Mallorca, Spain

RECRUITING

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Spain

RECRUITING

Hospital Universitario Donostia

San Sebastián, Spain

RECRUITING

Hospital Universitari General de Catalunya - Grupo Quirónsalud

Sant Cugat del Vallès, Spain

RECRUITING

Hospital Universitario San Juan de Alicante

Sant Joan d'Alacant, Spain

RECRUITING

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Spain

NOT YET RECRUITING

Hospital Clínico Universitario de Santiago

Santiago de Compostela, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, Spain

RECRUITING

Hospital Universitario de Toledo

Toledo, Spain

RECRUITING

Consorcio Hospital General Universitario de Valencia

Valencia, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, Spain

RECRUITING

Hospital Universitari Arnau de Vilanova (Valencia)

Valencia, Spain

NOT YET RECRUITING

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, Spain

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mothaffar F Rimawi, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaye L Thompson, Ph.D.

CONTACT

(832) 791-2542; Jaye.Thompson@GreenwichLifeSciences.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HLA-A\*02 subjects will be randomized to GLSI-100 or placebo. 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 Record Dates

• First Submitted: January 31, 2022
• First Posted: February 10, 2022
• Study Start: August 11, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (39); FR (20); IE (1); IT (10); DE (38); RO (4); US (45); PL (9)