Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
Recruiting · NCT05232916 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
GLSI-100Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Histologically confirmed diagnosis of HER2/neu positive primary breast cancer for all tumors biopsied at diagnosis (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.
Where it is running
60 locations listed across 24 US states.
- Southern Cancer Center - Mobile, Alabama, United States
- City of Hope - Cancer Center Phoenix - Goodyear, Arizona, United States
- Tucson Medical Center HealthCare - Tucson, Arizona, United States
- City of Hope - Duarte Cancer Center - Duarte, California, United States
- Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center - Fullerton, California, United States
- City of Hope - Orange County Lennar Foundation Cancer Center - Irvine, 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
- City of Hope - Cancer Center Atlanta - Newnan, Georgia, United States
- Northwestern University - Northwestern Memorial Hospital - Chicago, Illinois, United States
- City of Hope - Cancer Center Chicago - Zion, 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
- Hematology Oncology Associates - Medford, Oregon, 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
- Tennessee Cancer Specialists - Knoxville, Tennessee, United States
- SCRI Oncology Partners - Nashville, Tennessee, 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 Medical Center - 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
- Virginia Oncology Associates - Norfolk, Virginia, United States
- Shenandoah Oncology - Winchester, Virginia, United States
- Complejo Hospitalario Universitario de Albacete - Albacete, Spain
- Hospital General Universitario Dr. Balmis - Alicante, Spain
- Haematologie-Onkologie im Zentrum MVZ GmbH - Augsburg, Germany
- Sainte-Catherine - Institut du Cancer Avignon-Provence (ICAP) - Avignon, France
- Hospital Universitario de Badajoz - Badajoz, Spain
- Hospital Clínic de Barcelona - Barcelona, Spain
- Hospital del Mar - Barcelona, Spain
- Klinikum Bayreuth GmbH - Bayreuth, Germany
- Helios Klinikum Berlin-Buch GmbH - Berlin, Germany
Showing 60 of 179 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →