Clinical Trials
Flamingo-01 Phase III Clinical Trial
The Phase III clinical trial, Flamingo-01, has commenced.
Flamingo-01 Steering Committee
The Flamingo-01 Steering Committee is comprised of the following members:
- Dr. Mothaffar F. Rimawi – Professor of Medicine at the Baylor College of Medicine and Executive Medical Director and Co-Leader, Breast Cancer Program of the Dan L Duncan Comprehensive Cancer Center
- Dr. Francois-Clement Bidard – Professor of Medical Oncology, UVSQ/Paris Saclay University, Head of Breast Cancer Group, Institut Curie, Vice-Chair of the French Breast Cancer research group UCBG (Unicancer)
- Dr. William J. Gradishar – Professor of Medicine at the Feinberg School of Medicine at Northwestern University, Chief of Hematology and Oncology in the Department of Medicine, and Betsy Bramsen Professor of Breast Oncology
- Dr. Sibylle Loibl – Professor (apl) Goethe University Frankfurt/M, Clinical Consultant Centre for Haematology and Oncology/Bethanien Frankfurt/M, CEO of GBG Forschungs GmbH & Chair of the German Breast Group (GBG)
- Dr. Miguel Martin – Professor of Medicine, Head, Medical Oncology Service, Gregorio Marañón General University Hospital, Complutense University, Madrid, CEO of GEICAM
- Dr. Joyce A. O’Shaughnessy – Celebrating Women Chair in Breast Cancer, Baylor University Medical Center and Chair, Breast Cancer Program, Texas Oncology, US Oncology, Dallas, Texas
- Dr. Hope S. Rugo – Professor of Medicine and Winterhof Family Professor of Breast Oncology and Director, Breast Oncology and Clinical Trials Education, University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center
- Dr. Laura M. Spring – Assistant Professor, Medicine, Harvard Medical School, Attending Physician, Medical Oncology, Massachusetts General Hospital
- Dr. Cesar A. Santa-Maria – Associate Professor of Oncology, Breast and Gynecological Malignancies Group, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Flamingo-01 Overview
Flamingo-01 has a planned interim analysis, using a similar treatment regime as the completed Phase IIb clinical trial.
The primary objective of Flamingo-01 is to assess the safety and efficacy of GP2 compared to placebo in HLA-A*02 positive and HER2/neu positive breast cancer patients who have a high risk of disease recurrence (stage I, II, or III at presentation with residual disease at surgery; or, stage III at presentation with pathologic complete response at surgery) and have completed both neoadjuvant and postoperative, adjuvant trastuzumab-based standard of care therapy.
Trial details are available at clinicaltrials.gov:
A map showing the majority of participating clinical sites can be viewed, below. An interactive version can be viewed on large screens at clinicaltrials.gov, under the “Contacts and Locations” section.
Clinical site contact information can also be viewed at clinicaltrials.gov, under the “Contacts and Locations” section. Related general questions and participation interest can be emailed to:
Flamingo-01 Trial Design
The Flamingo-01 Phase III trial is a prospective, randomized, double-blinded, multi-center study. The patient population is defined by major screening criteria and stratified in order to balance the patient population between the treated and placebo arms of the trial.
Major Screening Criteria:
- HER2/neu Positive Breast Cancer
- HLA-A*02 Positive
- Residual disease post neo-adjuvant therapy and surgery
- pCR if Stage III at presentation
Stratified By:
- Residual disease/pCR
- Hormone receptor status
- Geographic region
As currently designed, approximately 500 HLA-A*02 patients will be randomized to receive GLSI-100 (GP2 and GM-CSF) or placebo control in the first two pivotal arms of the trial with a planned interim analysis. The primary endpoints of the pivotal arms will be blinded, but various other data such as immune response and safety may be open label. In addition, up to 250 non HLA-A*02 patients will be enrolled in the third open-label arm where all patients will receive GLSI-100 and where all endpoints will be open-label.
After 1 year of trastuzumab-based therapy or an approved biosimilar, 6 intradermal injections of GLSI-100 or saline placebo will be administered for the first 6 months as the Primary Immunization Series followed by 5 Boosters over the next 2.5 years for a total of 11 injections over 3 years of treatment. The participant duration of the trial will be 3 years treatment plus 1 year follow-up for a total of 4 years following the first year of treatment with trastuzumab-based therapy. Immune response analysis is planned at baseline and various timepoints.
- Primary Immunization Series: The objective of the Primary Immunization Series is to provide protection against breast cancer recurrence after immunity has peaked at approximately 6 months.
- Boosters: The objective of the Boosters is to maintain immunity and thereby protection for longer periods of time.
Phase III Clinical Trial Design — ASCO 2024
Poster TPS617: GP2 Phase III Clinical Trial Design for Preventing Breast Cancer Recurrence (view PDF here)
