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

NCT05710848 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-02-19

No results posted yet for this 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

  • Non-muscle-invasive Bladder Cancer

Interventions

DRUG

STM-416

STM-416 monotherapy

Sponsors & Collaborators

  • SURGE Therapeutics

    lead INDUSTRY

Principal Investigators

  • Seth Lerner, MD · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-11
Primary Completion
2026-05-31
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05710848 on ClinicalTrials.gov