SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery
- Registration Number
- NCT06300411
- Lead Sponsor
- SURGE Therapeutics
- Brief 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.
- Detailed 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, with 3 to 6 patients enrolled at each dose level, and a minimum of 6 patients enrolled at the highest dose level, for a total of approximately 12-18 patients in the dose escalation portion of the study.
SRG-514 doses will be escalated based on safety and potential dose-limiting toxicities (DLTs) within the 14-day period following SRG-514 administration. Patients who do not complete the DLT period for reasons other than study drug related toxicity would be considered non-evaluable for DLT assessment and may be replaced.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SRG-514 SRG-514 SRG-514
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Time on trial up to 60 days Incidence of serious adverse events (SAEs), and adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] 14 days Incidence of dose-limiting toxicities (DLTs) over the first 14-days of study treatment
- Secondary Outcome Measures
Name Time Method Wound healing Day 0, Day 1, Day 2, Day 7, Day 14, Day 60 Assessment of wound healing scored according to a modified ASEPSIS method
Pharmacokinetics of SRG-514 Day 0, Day 1, Day 2 Area under the plasma concentration versus time curve (AUC) of ketorolac in patient blood
Pharmacodynamics of SRG-514 Day 0, Day 1, Day 2, Day 7, Day 14 Pharmacodynamic assessments in blood will be listed and summarized by dose level
Trial Locations
- Locations (6)
NYU Langone Health
🇺🇸New York, New York, United States
Memorial Health
🇺🇸Savannah, Georgia, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Duke Cancer Center
🇺🇸Durham, North Carolina, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States