SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery
Purpose
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.
Condition
- Breast Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
Exclusion Criteria
- 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
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental SRG-514 |
SRG-514 |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
St Louis 4407066, Missouri 4398678 63110
More Details
- NCT ID
- NCT06300411
- Status
- Recruiting
- Sponsor
- SURGE Therapeutics
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.