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

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.

Eligibility

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.

Conditions1

Locations8 sites

Browse More Trials