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

Breast Cancer Clinical Trial

Official title:

A Phase 1 Study of SRG-514 Administered Intraoperatively to the Site of Tumor Resection of Patients Undergoing Breast-Conserving Cancer Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06300411
• Other study ID #: SRG-514-01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 2024
• Est. completion date: September 2025

Study information

• Verified date: February 2024
• Source: SURGE Therapeutics
• Contact: Kayti Aviano
• Phone: 781-605-8632
• Email: kayti[@]surgetx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• SRG-514
SRG-514 monotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SURGE Therapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]	Incidence of dose-limiting toxicities (DLTs) over the first 14-days of study treatment	14 days
Primary	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 on trial up to 60 days
Secondary	Pharmacokinetics of SRG-514	Maximum plasma concentration (Cmax) of ketorolac in patient blood	Day 0, Day 1, Day 2
Secondary	Pharmacokinetics of SRG-514	Area under the plasma concentration versus time curve (AUC) of ketorolac in patient blood	Day 0, Day 1, Day 2
Secondary	Pharmacodynamics of SRG-514	Pharmacodynamic assessments in blood will be listed and summarized by dose level	Day 0, Day 1, Day 2, Day 7, Day 14
Secondary	Wound healing	Assessment of wound healing scored according to a modified ASEPSIS method	Day 0, Day 1, Day 2, Day 7, Day 14, Day 60