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Cancer Vaccine

SRG-514 for Breast Cancer

Phase 1
Recruiting
Research Sponsored by SURGE Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18 years or older
Have Eastern Cooperative Oncology Group (ECOG) Performance Status <2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0, day 1, day 2, day 7, day 14, day 60
Awards & highlights
No Placebo-Only Group

Summary

This trial is the first time a new drug called SRG-514 is being tested on humans. The goal is to figure out the best dose of SRG-514 to give to patients having breast

Who is the study for?
This trial is for adults over 18, weighing more than 50kg, with a confirmed diagnosis of breast carcinoma or ductal carcinoma in situ (excluding inflammatory breast cancer), who are relatively active (ECOG <2), have good organ and bone marrow function, and plan to undergo surgery for breast cancer treatment. Prior chemotherapy is permitted.
What is being tested?
The study tests SRG-514 given during surgery to treat breast cancer. It's the first time this drug is being tested on humans. The trial will start by finding the right dose and then confirm that dose in more patients.
What are the potential side effects?
Since it's a first-in-human study, specific side effects of SRG-514 aren't known yet. However, potential risks may include typical surgical complications as well as any unexpected reactions to the new medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can do all or most of my daily activities without help.
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I have been diagnosed with breast cancer or ductal carcinoma in situ, but not inflammatory breast cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0, day 1, day 2, day 7, day 14, day 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0, day 1, day 2, day 7, day 14, day 60 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]
Secondary study objectives
Pharmacodynamics of SRG-514
Pharmacokinetics of SRG-514
Wound healing

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SRG-514Experimental Treatment1 Intervention
SRG-514

Find a Location

Who is running the clinical trial?

SURGE TherapeuticsLead Sponsor
2 Previous Clinical Trials
93 Total Patients Enrolled
~16 spots leftby Sep 2025
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