Study on STM-416 for Patients Undergoing Bladder Cancer Surgery

Sponsor: SURGE Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05710848

Provider View

This clinical trial is testing a new treatment, STM-416, for patients with recurrent bladder cancer who are undergoing surgery. The study aims to determine the safety and effectiveness of STM-416 when given during surgery.

Patient Parameters

Program Overview

This study is the first to test STM-416 in humans and is being conducted at multiple centers. It is designed to find out if STM-416 is safe and well-tolerated in patients with bladder cancer. The study is divided into two parts: Phase 1 will test increasing doses of STM-416 to find a safe dose, and Phase 2a will compare two different doses of STM-416 to see which is more effective when given during surgery for bladder cancer.

Description

The study involves two parts:

  • Phase 1: This part will test the safety of STM-416 by giving it in increasing doses to patients during their bladder cancer surgery. Up to 24 patients will participate, with 3 to 6 patients receiving each dose level. The goal is to find the highest dose that is safe.

  • Phase 2a: This part will compare two different doses of STM-416 to see which works better. Patients will be randomly assigned to receive one of the two doses during their surgery. After surgery, all patients will receive standard care treatment.

The study is open to patients who have a specific type of bladder cancer that has returned after previous treatment and who are undergoing surgery without additional chemotherapy at the time of surgery. The study will help determine if STM-416 can be a safe and effective addition to the treatment of bladder cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a history of a specific type of bladder cancer (high-grade Ta or T1 NMIBC) that has returned after previous treatment.
  • Be undergoing surgery for bladder cancer without additional chemotherapy at the time of surgery.
  • Be considered at high risk for cancer returning.
  • Have a performance status score of 0, 1, or 2, indicating good overall health.
  • Have adequate blood and organ function, including:
    • Hemoglobin level of at least 9.0 g/dL.
    • Neutrophil count of at least 1500 per mm3.
    • Platelet count of at least 75,000 per mm3.
    • Normal liver function tests.
    • Kidney function as measured by specific tests.

Exclusion Criteria

  • Have a history of certain types of bladder cancer (CIS or MIBC).
  • Are currently receiving other experimental treatments.
  • Have allergies to similar treatments or ingredients in STM-416.
  • Have uncontrolled health issues, such as infections, heart problems, or mental health conditions that would interfere with the study.
  • Women of childbearing potential are excluded in this phase to avoid bias, but may be included in future studies.

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