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NCT05232916 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
A Phase 3 study of Breast Cancer, sponsored by Greenwich LifeSciences.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 750
- Enrollment target
- 20
- Study locations
NCT05232916: Recruiting Phase 3 study of Breast Cancer, sponsored by Greenwich LifeSciences.
NCT05232916 is a Phase 3 study of Breast Cancer that is actively recruiting participants, run by Greenwich LifeSciences. The registered enrollment target is 750 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05232916, a Phase 3 study of Breast Cancer, is actively recruiting participants, sponsored by Greenwich LifeSciences.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 750 participants
- Enrollment target
- 20
- Study locations
Study Summary
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 Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL GLSI-100
Study Locations (20)
California
- City of Hope - Duarte Cancer Center - Duarte
- Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center - Fullerton
- City of Hope - Orange County Lennar Foundation Cancer Center - Irvine
- University of California San Diego - Moores Cancer Center - La Jolla
- University of Southern California - Norris Comprehensive Cancer Center - Los Angeles
- Stanford Medicine Cancer Center - Stanford Women's Cancer Center - Palo Alto
- University of California San Francisco - Helen Diller Family Comprehensive Cancer Center - San Francisco
- University of California Los Angeles - Hematology / Oncology Parkside - Santa Monica
- PIH Health Hospital - Whittier Hospital - Whittier
Arizona
- City of Hope - Cancer Center Phoenix - Goodyear
- Tucson Medical Center HealthCare - Tucson-Rudasill - Tucson
Florida
- University of Miami - Sylvester Comprehensive Cancer Center - Miami
- Moffitt Cancer Center - Tampa
Illinois
- Northwestern University - Northwestern Memorial Hospital - Chicago
- City of Hope - Cancer Center Chicago - Zion
Colorado
- Rocky Mountain Cancer Centers - Denver
Connecticut
- Yale Cancer Center - Smilow Cancer Hospital - New Haven
District of Columbia
- Johns Hopkins Medicine - Kimmel Cancer Center-Sibley Memorial Hospital - Washington D.C.
Georgia
- City of Hope - Cancer Center Atlanta - Newnan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 750 participants |
| Start Date | 2022-08-11 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05232916
The ClinicalTrials.gov registry entry for NCT05232916 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 750 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (73% lower). The listed sponsor is Greenwich LifeSciences, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05232916 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT05232916 about?
NCT05232916 is a clinical study titled "Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects". 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 car...
What is the current status of trial NCT05232916?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 750 participants. The study started on 2022-08-11. Estimated completion is 2026-12.
What conditions does trial NCT05232916 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT05232916?
The interventions under investigation include: Placebo (BIOLOGICAL), GLSI-100 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05232916?
This trial is sponsored by Greenwich LifeSciences, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05232916 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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