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

Description

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.

Conditions

Breast Cancer

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Study Overview

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Study Details

Study overview

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.

A Phase 1 Study of SRG-514 Administered Intraoperatively to the Site of Tumor Resection of Patients Undergoing Breast-Conserving Cancer Surgery

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

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Savannah

Memorial Health, Savannah, Georgia, United States, 31404

Indianapolis

Indiana University, Indianapolis, Indiana, United States, 46202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

SURGE Therapeutics,

Study Record Dates

2025-09