Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05710848
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2022-12-15
Brief Title:
A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer
Sponsor:
SURGE Therapeutics
Organization:
SURGE Therapeutics
Study Overview
Official Title:
A Phase 12a Study of STM-416 Administered Intraoperatively to Patients Undergoing Transurethral Resection of Bladder Tumor TURBT for Recurrent High-Grade Papillary Bladder Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a first-in-human FIH Phase 12a multi center open-label single treatment dose escalation and expansion study designed to determine the safety and tolerability of STM-416 in patients with bladder cancer
Detailed Description:
This is a 2-part multicenter first-in-human FIH Phase 12a study in patients with a history of pathologically confirmed high-grade Ta or T1 NMIBC without CIS who have completed SOC previously with recurrent papillary disease seen on cystoscopy and who are undergoing TURBT without perioperative intravesical chemotherapy All patients will receive relevant SOC therapy following TURBT SOC will be administered in the adjuvant setting
Phase 1 is an open-label single-treatment dose-escalation study to evaluate the safety and tolerability of up to 4 increasing doses of intraoperatively administered STM-416 utilizing a 33 convention with 3 to 6 patients enrolled in each STM-416 dose level with a minimum of 6 patients enrolled at the highest dose level for a total of approximately 24 patients
Phase 2a is a randomized single-blind single-treatment dose-expansion study that will comprise 2 arms TURBT STM-416 Dose 1 followed by SOC versus TURBT STM-416 Dose 2 followed by SOC
Phase 1 is an open-label single-treatment dose-escalation study to evaluate the safety and tolerability of up to 4 increasing doses of intraoperatively administered STM-416 utilizing a 33 convention with 3 to 6 patients enrolled in each STM-416 dose level with a minimum of 6 patients enrolled at the highest dose level for a total of approximately 24 patients
Phase 2a is a randomized single-blind single-treatment dose-expansion study that will comprise 2 arms TURBT STM-416 Dose 1 followed by SOC versus TURBT STM-416 Dose 2 followed by SOC
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?:
False
Is an FDA AA801 Violation?:
None