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SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery
Sponsor: SURGE Therapeutics
Summary
This is a multicenter, first-in-human (FIH), open label, Phase 1 dose escalation and recommended Phase 2 dose (RP2D) extension trial with a primary objective to define the RP2D of SRG-514 when administered intraoperatively to patients undergoing breast-conserving cancer surgery. SRG-514 will be investigated utilizing a 3+3 convention dose escalation cohorts.
Official title: A Phase 1 Study of SRG-514 Administered Intraoperatively to the Site of Tumor Resection of Patients Undergoing Breast-Conserving Cancer Surgery
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2024-07-29
Completion Date
2026-04-10
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
SRG-514
SRG-514 monotherapy
Locations (8)
Memorial Health
Savannah, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
Mayo
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
NYU Langone Health
New York, New York, United States
Duke Cancer Center
Durham, North Carolina, United States
MD Anderson Cancer Center
Houston, Texas, United States
Audie Murphy VA
San Antonio, Texas, United States