Trial purpose
Cancer treatment
Tumor type
Breast
Age
18+
Clinical summary
Summary
This trial aims to determine the recommended dose level of an immunotherapy drug called SRG-514 when it is given during breast-conserving cancer surgery.
It's a first-in-human study that involves a dose escalation stage, where increasing doses of SRG-514 will be administered to determine the recommended dose level for further assessment. This is called the Recommended Phase 2 Dose (RP2D).
To be eligible for this study, you should be planning to undergo breast-conserving surgical treatment for your breast cancer with curative intent. Adjuvant or neoadjuvant chemotherapy is allowed.
Conditions
This trial is treating people with breast cancer planning to undergo breast-conserving surgery
Eligibility
Inclusion
- 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
- 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.
Inclusion
- You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.
Exclusion
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
SURGE Therapeutics
Scientific Title
A Phase 1 Study of SRG-514 Administered Intraoperatively to the Site of Tumor Resection of Patients Undergoing Breast-Conserving Cancer Surgery
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