SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery
NCT06300411 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2026-02-17
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.
Conditions
Interventions
- DRUG
-
SRG-514
SRG-514 monotherapy
Sponsors & Collaborators
-
SURGE Therapeutics
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-29
- Primary Completion
- 2026-04-10
- Completion
- 2026-04-10
- FDA Drug
- Yes
Countries
- United States
Study Locations
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