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

NCT06300411 | Completed Phase 1 FDA Drug

• 1 other identifier: SRG-514-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 8

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.

Conditions

Breast Cancer

Keywords

Intraoperative; Ketorolac; Open-label; SRG-514; Dose escalation; Immunotherapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Pharmacokinetics of SRG-514

  Day 0, Day 1, Day 2

• Pharmacokinetics of SRG-514

  Day 0, Day 1, Day 2

• Pharmacodynamics of SRG-514

  Day 0, Day 1, Day 2, Day 7, Day 14

• Wound healing

  Day 0, Day 1, Day 2, Day 7, Day 14, Day 60

Study Arms (1)

SRG-514

EXPERIMENTAL

SRG-514

Drug: SRG-514

Interventions

SRG-514 DRUG

SRG-514 monotherapy

SRG-514

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• SURGE Therapeutics: lead

Study Sites (8)

Memorial Health

Savannah, Georgia, 31404, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Mayo

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Audie Murphy VA

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 8, 2024
• Study Start: July 29, 2024
• Primary Completion: April 8, 2026
• Study Completion: April 8, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)