Breast CancerPhase 1NCT06300411
SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery
A Phase 1 study testing SRG-514 in people with Breast Cancer, run by SURGE Therapeutics at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SRG-514
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 8 sitesUnited States
- Study dates
- 29 Jul 2024to 8 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Duke Cancer Center
Durham, North Carolina, 27710
MD Anderson Cancer Center
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
NYU Langone Health
New York, New York, 10016
Mayo
Rochester, Minnesota, 55905
Audie Murphy VA
San Antonio, Texas, 78229
Memorial Health
Savannah, Georgia, 31404
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- SRG-514
- Keywords
- Intraoperative, Ketorolac, Open-label, SRG-514, Dose escalation, Immunotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRG-514Drug
SRG-514 monotherapy
| Study group | Role | What they receive |
|---|---|---|
| SRG-514 | Experimental | SRG-514 Receives: Drug: SRG-514 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]
Incidence of dose-limiting toxicities (DLTs) over the first 14-days of study treatment
Measured: 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
Measured: Time on trial up to 60 days
Secondary outcomes (4)
Pharmacokinetics of SRG-514
Maximum plasma concentration (Cmax) of ketorolac in patient blood
Measured: Day 0, Day 1, Day 2
Pharmacokinetics of SRG-514
Area under the plasma concentration versus time curve (AUC) of ketorolac in patient blood
Measured: Day 0, Day 1, Day 2
Pharmacodynamics of SRG-514
Pharmacodynamic assessments in blood will be listed and summarized by dose level
Measured: Day 0, Day 1, Day 2, Day 7, Day 14
Wound healing
Assessment of wound healing scored according to a modified ASEPSIS method
Measured: Day 0, Day 1, Day 2, Day 7, Day 14, Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start29 Jul 2024
- Primary completion8 Apr 2026
- Study completion8 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- SURGE Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300411
- Sponsor's protocol ID
- SRG-514-01
- Status last verified
- May 2026
- First submitted
- 1 Mar 2024
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of SRG-514 Administered Intraoperatively to the Site of Tumor Resection of Patients Undergoing Breast-Conserving Cancer Surgery
- ClinicalTrials.gov ID
- NCT06300411
- Acronym / sponsor ID
- SRG-514-01
- Conditions
- Breast Cancer
- Keywords
- Intraoperative, Ketorolac, Open-label, SRG-514, Dose escalation, Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- SURGE TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 8 Apr 2026 (actual)
- Study completion
- 8 Apr 2026 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SRG-514 | Experimental | Drug: SRG-514SRG-514 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRG-514SRG-514 monotherapy | Drug | SRG-514 |
Primary outcome
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
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
4 secondary outcomes
Pharmacokinetics of SRG-514
Time frame: Day 0, Day 1, Day 2
Pharmacokinetics of SRG-514
Time frame: Day 0, Day 1, Day 2
Pharmacodynamics of SRG-514
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SRG-514 in people with Breast Cancer, run by SURGE Therapeutics at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.