RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-07-29
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06300411

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 18 years or older
  2. * Body weight \>50kg
  3. * Have a history of histologically confirmed diagnosis of breast carcinoma or ductal carcinoma in situ, except inflammatory breast cancer.
  4. * Plan to undergo breast-conserving surgical treatment of breast cancer with curative intent. Adjuvant or neoadjuvant chemotherapy is allowed.
  5. * Have Eastern Cooperative Oncology Group (ECOG) Performance Status \<2
  6. * Have adequate organ and bone marrow function at screening
  1. * Any known contraindication to ketorolac or other non-steroidal anti-inflammatory drugs (NSAIDs)
  2. * Patients anticipated to require the use of a drain after breast-conserving surgery (BCS)
  3. * Patients undergoing immediate reconstruction surgery, intraoperative radiation therapy (IORT) or brachytherapy requiring the placement of balloons or catheters during the lumpectomy procedure.

Contacts and Locations

Study Contact

Kayti Aviano
CONTACT
781-605-8632
kayti@surgetx.com

Study Locations (Sites)

Memorial Health
Savannah, Georgia, 31404
United States
Indiana University
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: SURGE Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-29
Study Completion Date2025-09

Study Record Updates

Study Start Date2024-07-29
Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

  • Intraoperative
  • Ketorolac
  • Open-label
  • SRG-514
  • Dose escalation
  • Immunotherapy

Additional Relevant MeSH Terms

  • Breast Cancer