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

Официальное название

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

Обзор

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.

Подробное описание

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 6 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 30 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.

Вмешательства

• Препарат STM-416
  STM-416 monotherapy

Первичные конечные точки

• Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] Phase 1 [Срок оценки: 21 days]
• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Phase 1 [Срок оценки: Time on trial up to 90 days]
• Recurrence free survival time (Phase 2a) [Срок оценки: Through study completion up to 24 months]

Вторичные конечные точки (3)

• Pharmacokinetics of STM-416 (Phase 1) [Срок оценки: Day 0, post 24 hours, post 48 hour]
• Pharmacokinetics of STM-416 (Phase 1) [Срок оценки: Day 0, post 24 hours, post 24 hour]
• Pharmacodynamics of STM-416 [Срок оценки: Day 0, post 24 hours, post 48 hours, post 21 days, post 90 days]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

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

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 20 центров

• East Valley Urology Center of Arizona — Mesa
• Arizona Urology Specialists — Tucson
• Arkansas Urology — Little Rock
• Unio Specialty Care - A Genesis Healthcare Partners Facility — Bakersfield
• Genesis Research — Downey
• Urology Center of Southern California — Murrieta
• Advanced Urology Institute — Daytona Beach
• University of Florida — Gainesville
• … и ещё 12 центров

Идентификаторы

NCT: NCT05710848 · STM-416-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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