Trials / Active Not Recruiting

Active Not RecruitingNCT06300411

SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery

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

Status: Active Not Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 24 (estimated)

Sponsor: SURGE Therapeutics · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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 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.

Conditions

Breast Cancer

Interventions

Type	Name	Description
DRUG	SRG-514	SRG-514 monotherapy

Timeline

Start date: 2024-07-29
Primary completion: 2026-04-10
Completion: 2026-04-10
First posted: 2024-03-08
Last updated: 2026-02-17

Locations

8 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06300411. Inclusion in this directory is not an endorsement.