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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT05232916

Run by

Greenwich LifeSciences, Inc.

People needed

2250

Starts

2022-12-16

Expected to finish

2031-12-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

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.

Where it is running

• Nebraska Medicine - University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• Tucson Medical Center HealthCare — Tucson, Arizona, United States (enrolling)
• City of Hope - Cancer Center Phoenix — Goodyear, Arizona, United States (enrolling)
• Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center — Fullerton, California, United States (enrolling)
• City of Hope - Orange County Lennar Foundation Cancer Center — Irvine, California, United States (enrolling)
• University of California San Diego - Moores Cancer Center — La Jolla, California, United States (enrolling)
• City of Hope - Duarte Cancer Center — Duarte, California, United States (enrolling)
• Stanford Medicine Cancer Center - Stanford Women's Cancer Center — Palo Alto, California, United States (enrolling)
• University of California San Francisco - Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States (enrolling)
• University of California Los Angeles - Hematology / Oncology Parkside — Santa Monica, California, United States (enrolling)
• PIH Health Hospital - Whittier Hospital — Whittier, California, United States (enrolling)
• Rocky Mountain Cancer Centers — Denver, Colorado, United States (enrolling)
• Yale Cancer Center - Smilow Cancer Hospital — New Haven, Connecticut, United States (enrolling)
• Johns Hopkins Medicine - Kimmel Cancer Center-Sibley Memorial Hospital — Washington D.C., District of Columbia, United States (enrolling)
• University of Miami - Sylvester Comprehensive Cancer Center — Miami, Florida, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• City of Hope - Cancer Center Atlanta — Newnan, Georgia, United States (enrolling)
• Northwestern University - Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
• City of Hope - Cancer Center Chicago — Zion, Illinois, United States (enrolling)
• Maryland Oncology Hematology — Annapolis, Maryland, United States (enrolling)
• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States (enrolling)
• Minnesota Oncology — Maple Grove, Minnesota, United States (enrolling)
• Siteman Cancer Center - Washington University Medical Campus — St Louis, Missouri, United States (enrolling)
• Nebraska Cancer Specialists — Omaha, Nebraska, United States (enrolling)
• Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States (enrolling)

Full record on ClinicalTrials.gov

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