Clinical trial NCT06300411: SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery
Official title: A Phase 1 Study of SRG-514 Administered Intraoperatively to the Site of Tumor Resection of Patients Undergoing Breast-Conserving Cancer Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Breast Cancer
Keywords: Intraoperative
Ketorolac
Open-label
SRG-514
Dose escalation
Immunotherapy
Lead sponsor: SURGE Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-03-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

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.

Primary outcomes:
measure: Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]
timeFrame: 14 days
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Time on trial up to 60 days
Secondary outcomes:
measure: Pharmacokinetics of SRG-514
timeFrame: Day 0, Day 1, Day 2
measure: Pharmacokinetics of SRG-514
timeFrame: Day 0, Day 1, Day 2
measure: Pharmacodynamics of SRG-514
timeFrame: Day 0, Day 1, Day 2, Day 7, Day 14
measure: Wound healing
timeFrame: Day 0, Day 1, Day 2, Day 7, Day 14, Day 60
Other outcomes:
Locations:
city: Savannah
country: United States
facility: Memorial Health
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Rochester
country: United States
facility: Mayo
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Audie Murphy VA
state: Texas
Study officials:
References: