SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery
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.
- EligibilityCriteria: 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. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult