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

C
Carla Fisher, MD

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase 1
3 participants needed
1 Location

Brief description of study

What is the purpose of this study?
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.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic. 
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

What will happen during the study?

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Breast Cancer
  • Age: 18 years - 100 years
  • Gender: All

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.

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.

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.

Updated on 06 Feb 2025. Study ID: CTO-SRG-514-01, 23453
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