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

NCT05710848 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: STM-416-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 10

Brief 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

Keywords

Open-label; Dose escalation; STM-416; Resiquimod; Toll-like receptor 7/8; Non-Muscle Invasive Bladder Cancer; TURBT; Immunotherapy; BCG

Outcome Measures

Primary Outcomes (3)

• Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] Phase 1

  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

  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)

  Recurrence will be evaluated by cystoscopy and urine cytology

  Through study completion up to 24 months

Secondary Outcomes (3)

• Pharmacokinetics of STM-416 (Phase 1)

  Day 0, post 24 hours, post 48 hour

• Pharmacokinetics of STM-416 (Phase 1)

  Day 0, post 24 hours, post 24 hour

• Pharmacodynamics of STM-416

  Day 0, post 24 hours, post 48 hours, post 21 days, post 90 days

Study Arms (1)

STM-416

EXPERIMENTAL

STM-416

Drug: STM-416

Interventions

STM-416 DRUG

STM-416 monotherapy

STM-416

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Have a history of CIS or MIBC;
• Are receiving any other investigational agents;
• 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;
• 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.
• 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.

Sponsors & Collaborators

• SURGE Therapeutics: lead

Study Sites (10)

Arizona Urology Specialists

Tucson, Arizona, 85715, United States

RECRUITING

University of Florida

Gainesville, Florida, 32608, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Duke Cancer Center

Durham, North Carolina, 27710, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43221, United States

RECRUITING

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Urology Associates, P.C.

Nashville, Tennessee, 37209, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Houston Methodist

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Seth Lerner, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kayti Aviano

CONTACT

781-605-8632; kayti@surgetx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Singe group assignment

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: February 2, 2023
• Study Start: July 11, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)