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Cancer Vaccine

GLSI-100 for Condition (FLAMINGO-01 Trial)

Phase 3
Recruiting
Led By Mothaffar F Rimawi, MD
Research Sponsored by Greenwich LifeSciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed diagnosis of HER2/neu positive primary breast cancer
Completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast cancer therapy
Timeline
Screening 10 days
Treatment 36 months
Follow Up 48 months
Awards & highlights

FLAMINGO-01 Trial Summary

This trial is testing an immunotherapy called GLSI-100 to see if it can help prevent disease recurrence in people who are at high risk and have completed standard treatment. The immunotherapy consists of 6 injections given over the first 6 months, followed by 5 more injections given every 6 months.

FLAMINGO-01 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is confirmed to be HER2 positive.
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I have completed all recommended treatments for breast cancer that included trastuzumab.
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My cancer was stage I, II, or III and still present after initial treatment, or it was stage III but fully treated with initial therapy.
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I can start the study within a year after finishing my last trastuzumab-based treatment.
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My doctor has found no signs of remaining breast cancer.
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I can take care of myself and am up and about more than half of the day.

FLAMINGO-01 Trial Timeline

Screening ~ 10 days
Treatment ~ 36 months
Follow Up ~48 months
This trial's timeline: 10 days for screening, 36 months for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Invasive Breast Cancer-free Survival (IBCFS)
Secondary outcome measures
Distant Disease-free Survival (DDFS)
Invasive Disease-free Survival (IDFS)
Overall Survival
+2 more
Other outcome measures
Immune Response Measurements

FLAMINGO-01 Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: GLSI-100, Open-labelExperimental Treatment1 Intervention
Open-label arm: GLSI-100 immunotherapy in non-HLA-A*02 positive and HER2/neu positive subjects administered intradermally every month for first 6 months then every 6 months for next 2.5 years (11 intradermal injections over 3 years)
Group II: GLSI-100Experimental Treatment1 Intervention
GLSI-100 immunotherapy in HLA-A*02 positive and HER2/neu positive subjects administered intradermally every month for first 6 months then every 6 months for next 2.5 years (11 intradermal injections over 3 years)
Group III: 0.9% Normal SalinePlacebo Group1 Intervention
0.9% normal saline in HLA-A*02 positive and HER2/neu positive subjects administered intradermally every month for first 6 months then every 6 months for next 2.5 years (11 intradermal injections over 3 years)

Find a Location

Who is running the clinical trial?

Greenwich LifeSciences, Inc.Lead Sponsor
Mothaffar F Rimawi, MDPrincipal InvestigatorBaylor College of Medicine
2 Previous Clinical Trials
162 Total Patients Enrolled

Media Library

GLSI-100 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05232916 — Phase 3
Condition Research Study Groups: 0.9% Normal Saline, GLSI-100, GLSI-100, Open-label
Condition Clinical Trial 2023: GLSI-100 Highlights & Side Effects. Trial Name: NCT05232916 — Phase 3
GLSI-100 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05232916 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does GLSI-100 have any dangerous side effects that people should be aware of?

"GLSI-100 has received a safety score of 3 by our team at Power. This is because there is some evidence from Phase 3 trials of both efficacy and safety."

Answered by AI

Are there many different medical clinics running this study in this city?

"There are a total of 16 sites running this clinical trial, for example Virginia Cancer Specialists in Fairfax, Compass Oncology (USOR) in Tigard, and Texas Oncology San Antonio (USOR)."

Answered by AI

Can adults enroll in this clinical research?

"Individuals aged 18 to 100 who meet the other requirements specified in the inclusion criteria are eligible for this trial. There are currently 53 studies underway for people under 18 and 1374 for people over 65."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Florida
What site did they apply to?
University of Southern California
Columbia University
Texas Oncology - Austin
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

To help find cure and improved treatment for metastatic breast cancer.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Texas Oncology San Antonio (USOR): < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
2022. "Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05232916.
~363 spots leftby Dec 2026
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