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

January 17, 2024 updated by: SURGE Therapeutics

A Phase 1/2a Study of STM-416 Administered Intraoperatively to Patients Undergoing Transurethral Resection of Bladder Tumor (TURBT) for Recurrent High-Grade Papillary 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a 2-part, multicenter, first-in-human (FIH), Phase 1/2a 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 3+3 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 Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Recruiting
        • Arizona Urology Specialists
        • Contact:
        • Principal Investigator:
          • Susan Kalota, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Boris Gershman, MD
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Carolina Urologic Research Center
        • Contact:
        • Principal Investigator:
          • Abhishek Srivastava, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • Recruiting
        • Urology Associates, P.C.
        • Principal Investigator:
          • Gautam Jayram, MD
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
        • Contact:
        • Principal Investigator:
          • Yair Lotan, M.D.
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
        • Principal Investigator:
          • Seth Paul Lerner, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Are aged 18 years or older;
  2. Have 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;
  3. Are considered high risk for recurrence;
  4. Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2;

  5. Have adequate organ and marrow function as defined below:

    • Hemoglobin 9.0 g/dL;
    • Absolute neutrophil count 1.5 × 109/L (1500 per mm3);
    • Platelet count 75 × 109/L (75,000 per mm3);
    • Serum bilirubin 1.5 × institutional upper limit of normal (ULN);
    • AST (serum glutamic-oxaloacetic transaminase)/ALT (serum glutamic-pyruvic transaminase) 2.5 × institutional ULN; and
    • Creatinine CL 60 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine CL: Males: Creatinine CL (mL/min) = Weight (kg) × (140 - Age)/72 × serum creatinine (mg/dL); or Females: Creatinine CL (mL/min) = Weight (kg) × (140 - Age) × 0.85/72 × serum creatinine (mg/dL).

Exclusion Criteria:

  1. Have a history of CIS or MIBC;
  2. Are receiving any other investigational agents;
  3. Have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to resiquimod (R848), or excipients used in STM-416 including poloxamer 407 and sodium hyaluronate;

  4. Have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

    Urinary tract infections are not exclusionary unless they are NCI-CTCAE Grade 3 or higher;

  5. Are a woman of childbearing potential regardless of contraceptive use; Note: Women of childbearing potential are only to be excluded in Phase 1 and Phase 2a to avoid bias due to the low prevalence of NMIBC in this population. However, they will be included in subsequent Phase 2/3 studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: STM-416
Drug: STM-416
STM-416 monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] Phase 1
Time Frame: 21 days
Incidence of dose-limiting toxicities (DLTs) over the first 21-days of study treatment
21 days
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Phase 1
Time Frame: Time on trial up to 90 days
Incidence of serious adverse events (SAEs), and adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Time on trial up to 90 days
Recurrence free survival time (Phase 2a)
Time Frame: Through study completion up to 24 months
Recurrence will be evaluated by cystoscopy and urine cytology
Through study completion up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of STM-416 (Phase 1)
Time Frame: Day 0, post 24 hours, post 24 hour
Maximum plasma concentration (Cmax) of resiquimod (R848) in patient blood for the single dose level (Phase 1)
Day 0, post 24 hours, post 24 hour
Pharmacokinetics of STM-416 (Phase 1)
Time Frame: Day 0, post 24 hours, post 24 hour
Area under the plasma concentration versus time curve (AUC) of resiquimod (R848) in patient blood for the single dose level (Phase 1)
Day 0, post 24 hours, post 24 hour
Pharmacodynamics of STM-416
Time Frame: Day 0, post 24 hours, post 48 hours, post 21 days, post 90 days
Pharmacodynamic assessments in plasma and urine will be listed and summarized by dose level for Phase 1/2a
Day 0, post 24 hours, post 48 hours, post 21 days, post 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SURGE Therapeutics

Investigators

  • Principal Investigator: Seth Lerner, MD, Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

December 15, 2022

First Submitted That Met QC Criteria

January 25, 2023

First Posted (Actual)

February 2, 2023

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STM-416-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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