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NCT05710848 · ClinicalTrials.gov registry record · Phase 1

A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer

A Phase 1 study of Non-muscle Invasive Bladder Cancer, sponsored by SURGE Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
75
Enrollment target
10
Study locations

NCT05710848 is a Phase 1 study of Non-muscle Invasive Bladder Cancer that is actively recruiting participants, run by SURGE Therapeutics. The registered enrollment target is 75 participants, below the 230-participant average among 28 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (67% lower). The trial reports 10 study locations across 8 states.

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The verdict

NCT05710848, a Phase 1 study of Non-muscle Invasive Bladder Cancer, is actively recruiting participants, sponsored by SURGE Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
75 participants
Enrollment target
10
Study locations

Study Summary

This is a first-in-human (FIH), Phase 1/2a, 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.

Conditions Studied

Non-muscle Invasive Bladder Cancer

Interventions

  • DRUG STM-416

Study Locations (10)

Texas

  • University of Texas Southwestern Medical Center - Dallas
  • Baylor College of Medicine - Houston
  • Houston Methodist - Houston

Arizona

  • Arizona Urology Specialists - Tucson

Florida

  • University of Florida - Gainesville

Massachusetts

  • Beth Israel Deaconess Medical Center - Boston

North Carolina

  • Duke Cancer Center - Durham

Ohio

  • The Ohio State University - Columbus

South Carolina

  • Carolina Urologic Research Center - Myrtle Beach

Tennessee

  • Urology Associates, P.C. - Nashville

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2023-07-11
Est. Completion 2026-08
Phase Phase 1

Sponsor

SURGE Therapeutics

3 total trials

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What the Registry Record Tells You About NCT05710848

The ClinicalTrials.gov registry entry for NCT05710848 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 230-participant average among 28 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (67% lower). The listed sponsor is SURGE Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Non-muscle Invasive Bladder Cancer appearing as the primary indexed condition, and to 1 intervention - of which STM-416 is the first listed.

NCT05710848 reports 10 study locations spanning 8 distinct geographic areas - top geographies include Texas, Arizona, Florida.

Frequently Asked Questions

What is clinical trial NCT05710848 about?

NCT05710848 is a clinical study titled "A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer". This is a first-in-human (FIH), Phase 1/2a, 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.

What is the current status of trial NCT05710848?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2023-07-11. Estimated completion is 2026-08.

What conditions does trial NCT05710848 study?

This clinical trial studies the following conditions: Non-muscle Invasive Bladder Cancer.

What interventions are being tested in trial NCT05710848?

The interventions under investigation include: STM-416 (DRUG).

Who is sponsoring clinical trial NCT05710848?

This trial is sponsored by SURGE Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05710848 being conducted?

This trial has 10 study locations across Arizona, Florida, Massachusetts, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.