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

March 7, 2024 updated by: SURGE Therapeutics

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SRG-514
Drug: SRG-514
SRG-514 monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]
Time Frame: 14 days
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]
Time Frame: 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
Time on trial up to 60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of SRG-514
Time Frame: Day 0, Day 1, Day 2
Maximum plasma concentration (Cmax) of ketorolac in patient blood
Day 0, Day 1, Day 2
Pharmacokinetics of SRG-514
Time Frame: Day 0, Day 1, Day 2
Area under the plasma concentration versus time curve (AUC) of ketorolac in patient blood
Day 0, Day 1, Day 2
Pharmacodynamics of SRG-514
Time Frame: Day 0, Day 1, Day 2, Day 7, Day 14
Pharmacodynamic assessments in blood will be listed and summarized by dose level
Day 0, Day 1, Day 2, Day 7, Day 14
Wound healing
Time Frame: Day 0, Day 1, Day 2, Day 7, Day 14, Day 60
Assessment of wound healing scored according to a modified ASEPSIS method
Day 0, Day 1, Day 2, Day 7, Day 14, Day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SURGE Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SRG-514-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on SRG-514

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe