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Trial Title:
SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery
NCT ID:
NCT06300411
Condition:
Breast Cancer
Conditions: Keywords:
Intraoperative
Ketorolac
Open-label
SRG-514
Dose escalation
Immunotherapy
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SRG-514
Description:
SRG-514 monotherapy
Arm group label:
SRG-514
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Health
Address:
City:
Savannah
Zip:
31404
Country:
United States
Status:
Recruiting
Contact:
Last name:
Karen Sather
Email:
karen.sather@hcahealthcare.com
Investigator:
Last name:
William Burak, MD
Email:
Principal Investigator
Facility:
Name:
Indiana University
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Grace Lander
Email:
glander@iu.edu
Investigator:
Last name:
Carla Fisher, MD
Email:
Principal Investigator
Start date:
July 29, 2024
Completion date:
September 2025
Lead sponsor:
Agency:
SURGE Therapeutics
Agency class:
Industry
Source:
SURGE Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06300411
