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ACTIVE NOT RECRUITING
NCT06300411
PHASE1

SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery

Sponsor: SURGE Therapeutics

View on ClinicalTrials.gov

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

DRUG

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