Open Actively Recruiting

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

About

Brief Summary

This is a prospective, randomized, double-blinded, placebo-controlled, multi-center, Phase 3 study of GLSI-100 immunotherapy in HLA-A02 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-A02 positive and HER2/neu positive subjects.

Primary Purpose
Prevention
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
100 Years

Inclusion Criteria:

  • HLA-A02-positive, unless being enrolled in the third non-HLA-A02 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 90 days 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

Exclusion Criteria:

  • Stage IV cancer or metastatic breast cancer at any time
  • Inflammatory breast cancer
  • Receiving other investigational agents
  • Receiving chemotherapy
  • Requiring 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.

Join this Trial

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Study Stats
Protocol No.
22-000668
Category
Hematology-Oncology
Oncology
Contact
Monica Rocha
Location
  • TRIO-US - Las Vegas
  • TRIO-US - Redondo Beach
  • TRIO-US - Whittier
  • UCLA Parkside
  • UCLA Santa Monica
For Providers
NCT No.
NCT05232916
For detailed technical eligibility, visit ClinicalTrials.gov.