#1 Clinical Trials Search in Europe

L-Isoleucyl-L-Isoleucyl-L-Seryl-L-Alanyl-L-Valyl-L-Valyl-Glycyl-L-Isoleucyl-L-Leucine

A new clinical trial is underway to assess the effectiveness of a drug called GLSI-100, which combines GP2 (a HER2/neu peptide) with GM-CSF, for patients with HER2-positive breast cancer. This study focuses on patients who have a high risk of disease recurrence after completing standard treatments. The trial aims to determine if GLSI-100 can improve outcomes for these patients compared to a placebo.

Table of Contents

What is GLSI-100?

GLSI-100 is a potential new therapy for HER2-positive breast cancer. It consists of two components[1]:

  1. GP2: A peptide (small protein fragment) also known as L-ISOLEUCYL-L-ISOLEUCYL-L-SERYL-L-ALANYL-L-VALYL-L-VALYL-GLYCYL-L-ISOLEUCYL-L-LEUCINE
  2. GM-CSF: Granulocyte-macrophage colony-stimulating factor, also called sargramostim

This combination is being studied as a potential treatment to prevent the recurrence of breast cancer in patients who have already completed standard treatments.

Target Population

GLSI-100 is designed for patients with HER2-positive breast cancer who[1]:

  • Have completed both neoadjuvant (before surgery) and adjuvant (after surgery) trastuzumab-based therapy
  • Have a high risk of disease recurrence, including:
    • Patients with stage I, II, or III cancer at initial diagnosis who have residual disease after surgery
    • Patients with stage III cancer at initial diagnosis who achieved a pathologic complete response (pCR) after surgery

How GLSI-100 Works

GLSI-100 is designed to stimulate the immune system to recognize and attack HER2-positive cancer cells[1]:

  • GP2 is a peptide that mimics part of the HER2 protein found on breast cancer cells
  • GM-CSF helps activate immune cells
  • Together, they aim to “train” the immune system to recognize and eliminate any remaining cancer cells, potentially preventing recurrence

Clinical Trial Details

A phase 3 clinical trial called FLAMINGO-01 is currently studying GLSI-100[1]:

  • It is a randomized, multicenter, placebo-controlled study
  • The main goal is to assess how effective GLSI-100 is compared to a placebo in preventing breast cancer recurrence
  • The study will measure Invasive Breast Cancer-Free Survival (IBCFS), which is the time from starting the treatment until the cancer returns or the patient dies from any cause

Eligibility Criteria

To participate in the FLAMINGO-01 trial, patients must meet specific criteria, including[1]:

  • HER2-positive breast cancer diagnosis
  • Completed standard trastuzumab-based therapy
  • No current evidence of cancer
  • Able to start the study treatment within one year of completing standard therapy
  • Adequate organ function

Some factors that may exclude patients from participating include:

  • Stage IV or metastatic breast cancer
  • Inflammatory breast cancer
  • Currently receiving chemotherapy or other investigational treatments
  • History of serious allergic reactions to similar treatments

Potential Benefits

If successful, GLSI-100 could offer several benefits to patients[1]:

  • Reduced risk of breast cancer recurrence
  • Improved overall survival
  • Better quality of life for breast cancer survivors

Safety and Side Effects

The FLAMINGO-01 trial will closely monitor the safety of GLSI-100[1]:

  • Researchers will track the frequency and severity of side effects
  • Side effects will be categorized using standardized criteria (NIH CTCAE, version 5.0)
  • The study will assess how these side effects relate to the treatment

It’s important to note that as this is an ongoing clinical trial, the full safety profile of GLSI-100 is not yet known. Patients considering participation should discuss potential risks and benefits with their healthcare provider.

Aspect Details
Study Type Phase 3, randomized, multicenter, placebo-controlled
Drug Name GLSI-100 (GP2 + GM-CSF)
Target Population HER2-positive breast cancer patients with high risk of recurrence
Main Eligibility Criteria HLA-A*02 positive, completed neoadjuvant and adjuvant trastuzumab-based therapy
Primary Endpoint Invasive Breast Cancer-Free Survival (IBCFS)
Secondary Endpoints Invasive Disease-Free Survival (IDFS), Overall Survival (OS), Quality of Life, Safety
Treatment Duration Up to 36 months
Administration Route Intradermal injection

FAQ

  • What is the main goal of this clinical trial? The main goal is to assess how well GLSI-100 works compared to a placebo in preventing breast cancer recurrence in HER2-positive patients who have completed standard treatments but still have a high risk of the cancer coming back.
  • Who can participate in this study? Participants must have HER2-positive breast cancer, have completed both neoadjuvant and adjuvant trastuzumab-based therapy, and either have residual disease after surgery or had stage III cancer with a complete response to treatment. They must also be HLA-A*02-positive, unless enrolled in a specific non-HLA-A*02 arm of the study.
  • What does the treatment involve? The treatment involves receiving either GLSI-100 (which combines GP2 and GM-CSF) or a placebo. The drug is given through an intradermal injection, which means it's injected just under the skin.
  • How long does the study last? The maximum treatment period is 36 months (3 years), but the study will continue to follow patients to measure long-term outcomes such as survival and cancer recurrence.
  • What are the potential benefits of participating in this trial? Participants may benefit from a new treatment that could potentially reduce the risk of breast cancer recurrence. Additionally, they will contribute to important research that may help future breast cancer patients. However, it's important to note that not all participants will receive the active treatment, as some will receive a placebo.

Ongoing Clinical Trials on L-Isoleucyl-L-Isoleucyl-L-Seryl-L-Alanyl-L-Valyl-L-Valyl-Glycyl-L-Isoleucyl-L-Leucine

  • Study on the Effectiveness of GP2 and Sargramostim for HER2 Positive Breast Cancer Patients with Residual Disease or High-Risk After Standard Therapy

    Recruiting

    3 1
    Investigated drugs:
    Austria Belgium France Germany Ireland Italy +4

Glossary

  • HER2-positive breast cancer: A type of breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells.
  • Neoadjuvant therapy: Treatment given before the main treatment, usually before surgery, to shrink the tumor.
  • Adjuvant therapy: Additional treatment given after the primary treatment to lower the risk of the cancer coming back.
  • Trastuzumab: A targeted therapy drug used to treat HER2-positive breast cancer.
  • Pathologic complete response (pCR): When there is no evidence of cancer in tissue samples removed during surgery after neoadjuvant therapy.
  • GLSI-100: The investigational drug being studied, which combines GP2 (a HER2/neu peptide) with GM-CSF.
  • GP2: A peptide derived from the HER2/neu protein, used in this study as part of the GLSI-100 treatment.
  • GM-CSF (Sargramostim): Granulocyte-macrophage colony-stimulating factor, a substance that helps stimulate the immune system.
  • Intradermal injection: A method of injecting a substance directly into the layer of skin below the surface.
  • HLA-A*02: A specific type of human leukocyte antigen (HLA) gene, which plays a role in the immune system's ability to recognize the GP2 peptide.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-gp2-and-sargramostim-for-her2-positive-breast-cancer-patients-with-residual-disease-or-high-risk-after-standard-therapy/