Clinical Trial: NCT06300411
SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | SURGE Therapeutics |
| Information Provided By: | SURGE Therapeutics |
| Last Update Posted: | 2026-05-28 |
Study Overview
Brief 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. SRG-514 will be investigated utilizing a 3+3 convention dose escalation cohorts.
Official Title
A Phase 1 Study of SRG-514 Administered Intraoperatively to the Site of Tumor Resection of Patients Undergoing Breast-Conserving Cancer Surgery
Conditions
Breast Cancer
Intervention / Treatment
- Drug: SRG-514
Other Study ID Numbers
- SRG-514-01
Start Date (Actual)
2024-07-29
Primary Completion Date (Actual)
2026-04-08
Study Completion Date (Actual)
2026-04-08
Enrollment (Actual)
25
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | SURGE Therapeutics |
| Information Provided By: | SURGE Therapeutics |
| Last Update Posted: | 2026-05-28 |
Study Overview
Brief 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. SRG-514 will be investigated utilizing a 3+3 convention dose escalation cohorts.
Official Title
A Phase 1 Study of SRG-514 Administered Intraoperatively to the Site of Tumor Resection of Patients Undergoing Breast-Conserving Cancer Surgery
Conditions
Breast Cancer
Intervention / Treatment
- Drug: SRG-514
Other Study ID Numbers
- SRG-514-01
Start Date (Actual)
2024-07-29
Primary Completion Date (Actual)
2026-04-08
Study Completion Date (Actual)
2026-04-08
Enrollment (Actual)
25
Study Type
Interventional
Phase
Phase 1