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

SURGE Therapeutics

Status and phase

Enrolling

Phase 1

Conditions

Breast Cancer

Treatments

Drug: SRG-514

Study type

Interventional

Funder types

Industry

Identifiers

NCT06300411

SRG-514-01

Details and patient eligibility

About

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.