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

Completed · Phase 1

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT06300411

Run by

SURGE Therapeutics

People needed

25

Starts

2024-07-29

Expected to finish

2026-04-08

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18 years or older
• Body weight >50kg
• Have a history of histologically confirmed diagnosis of breast carcinoma or ductal carcinoma in situ, except inflammatory breast cancer.
• Plan to undergo breast-conserving surgical treatment of breast cancer with curative intent. Adjuvant or neoadjuvant chemotherapy is allowed.
• Have Eastern Cooperative Oncology Group (ECOG) Performance Status <2
• Have adequate organ and bone marrow function at screening

You may not qualify if…

• Any known contraindication to ketorolac or other non-steroidal anti-inflammatory drugs (NSAIDs)
• Patients anticipated to require the use of a drain after breast-conserving surgery (BCS)
• Patients undergoing immediate reconstruction surgery, intraoperative radiation therapy (IORT) or brachytherapy requiring the placement of balloons or catheters during the lumpectomy procedure.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.