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

Phase 1Active Not RecruitingNCT06300411

SURGE Therapeutics24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

SRG-514DRUG

SRG-514 monotherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (8)

Memorial Health

Savannah, Georgia, United States

Indiana University

Indianapolis, Indiana, United States

Mayo

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]

Incidence of dose-limiting toxicities (DLTs) over the first 14-days of study treatment

Time frame: 14 days

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

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

Time frame: Time on trial up to 60 days

Secondary Outcomes

Pharmacokinetics of SRG-514

Maximum plasma concentration (Cmax) of ketorolac in patient blood

Time frame: Day 0, Day 1, Day 2

Pharmacokinetics of SRG-514

Area under the plasma concentration versus time curve (AUC) of ketorolac in patient blood

Time frame: Day 0, Day 1, Day 2

Pharmacodynamics of SRG-514

Pharmacodynamic assessments in blood will be listed and summarized by dose level

Time frame: Day 0, Day 1, Day 2, Day 7, Day 14

Wound healing

Assessment of wound healing scored according to a modified ASEPSIS method

Time frame: Day 0, Day 1, Day 2, Day 7, Day 14, Day 60

Data from ClinicalTrials.gov

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