Breast Cancer
Conditions
Keywords
Intraoperative, Ketorolac, Open-label, SRG-514, Dose escalation, Immunotherapy
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.
Interventions
DRUGSRG-514
SRG-514 monotherapy
Sponsors
SURGE Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] | 14 days | Incidence of dose-limiting toxicities (DLTs) over the first 14-days of study treatment |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Time on trial up to 60 days | Incidence of serious adverse events (SAEs), and adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of SRG-514 | Day 0, Day 1, Day 2 | Maximum plasma concentration (Cmax) of ketorolac in patient blood |
| Pharmacodynamics of SRG-514 | Day 0, Day 1, Day 2, Day 7, Day 14 | Pharmacodynamic assessments in blood will be listed and summarized by dose level |
| Wound healing | Day 0, Day 1, Day 2, Day 7, Day 14, Day 60 | Assessment of wound healing scored according to a modified ASEPSIS method |
Countries
United States
Outcome results
None listed