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

Description

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

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Study Overview

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Study Details

Study overview

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.

A Randomized, Multicenter, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu Positive Subjects with Residual Disease or High-Risk PCR After Both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy (FLAMINGO-01)

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

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Tucson

Arizona Oncology Associates, Tucson, Arizona, United States, 85745

Fullerton

Providence St. Jude Medical Center, Fullerton, California, United States, 92835

Los Angeles

University of Southern California - Norris Comprehensive Cancer Center, Los Angeles, California, United States, 90033

Palo Alto

Stanford University Women's Cancer Center, Palo Alto, California, United States, 74304

San Francisco

University of California San Francisco - Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States, 94158

Santa Monica

University of California Los Angeles Hematology / Oncology Parkside, Santa Monica, California, United States, 90404

Torrance

Torrance Memorial Physicians Network, Torrance, California, United States, 90505

Whittier

PIH Health Hospital - Whittier, Whittier, California, United States, 90602

Denver

Rocky Mountain Cancer Centers, Denver, Colorado, United States, 80220

New Haven

Yale University Cancer Center, New Haven, Connecticut, United States, 06511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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.
  • * 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.

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Greenwich LifeSciences, Inc.,

Mothaffar F Rimawi, MD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

2026-12