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SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery
Trial Status: active
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.
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.
Additional locations may be listed on ClinicalTrials.gov for NCT06300411.
Locations matching your search criteria
United States
Indiana
Indianapolis
Indiana University/Melvin and Bren Simon Cancer Center
Status: Active
Name Not Available
Minnesota
Rochester
Mayo Clinic in Rochester
Status: Active
Name Not Available
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
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.
