Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06300411
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-03-01
Brief Title:
SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery
Sponsor:
SURGE Therapeutics
Organization:
SURGE Therapeutics
Study Overview
Official Title:
A Phase 1 Study of SRG-514 Administered Intraoperatively to the Site of Tumor Resection of Patients Undergoing Breast-Conserving Cancer Surgery
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 33 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 33 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None