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

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 224-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (67% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Incidence of dose-limiting toxicities (DLTs) over the first 21-days of study treatment

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
SURGE Therapeutics

3 total trials

What NCT05710848 shows while recruiting

NCT05710848 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 224-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (67% lower).

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 lists 10 locations in 8 states (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.

Learn More About Clinical Trials

Similar trials for Non-muscle Invasive Bladder Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05710848's enrollment target sits among peer trials

75 18th of 30 higher than 13 of 30 other Non-muscle Invasive Bladder Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Non-muscle Invasive Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05710848

Source: ClinicalTrials.gov NCT05710848, the US trial registry maintained by the National Library of Medicine. NCT05710848 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.