The Study is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With NMIBC, and to Determine the RP2D of SPGL008 Alone or in Combination With BCG.To Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG.

Официальное название

Phase I/II Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of SPGL008 as Monotherapy or in Combination With BCG in Patients With Non-Muscle-Invasive Bladder Cancer

Обзор

The goal of clinical trial is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With on-Muscle-Invasive Bladder Cancer. The main questions it aims to answer are: 1. Determine the recommend Phase II dose of SPGL008 Alone or in Combination With BCG.To 2. Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG.

Вмешательства

• Биопрепарат SPGL008
  Biological product

Первичные конечные точки

• Maximum tolerated dose [Срок оценки: Approximately 2years]
• Dose-limiting toxicity [Срок оценки: 7 days]
• Recommended Phase 2 dose (RP2D) [Срок оценки: Approximately 2 years.]
• CR Rate (cohort A) [Срок оценки: Approximately 4 years.]
• 12-month DFS Rate (cohort B/C) [Срок оценки: Approximately 12 months]

Вторичные конечные точки (5)

• Treatment-Related Adverse Events as assessed by CTCAE v5.0 [Срок оценки: Approximately 4 years.]
• Duration of CR (DoR) [Срок оценки: Approximately 4 years.]
• DFS [Срок оценки: Approximately 4 years.]
• Time to cystectomy [Срок оценки: Approximately 4 years.]
• Radical cystectomy rate [Срок оценки: Approximately 4 years.]

Критерии участия

Критерии включения

• Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent in writing;
• Age ≥ 18 years old, gender is not limited;
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
• Expected survival time ≥ 2 years;
• High-risk NMIBC diagnosed by previous pathological biopsy
• ineligible or unwilling to undergo radical cystectomy;
• The level of organ function is good.

Критерии исключения

• Currently receiving study treatment in other clinical trials or less than 4 weeks from last participation to the first administration of this study;
• Upper urinary tract tumor detected by CTU or MRU during screening period, urethral prostate tumor detected by cystoscopy, or other concomitant malignant tumors within 5 years before the first administration;
• Previous medical history or examination suggests active tuberculosis within 1 year prior to the first dose;
• Serious infection within 4 weeks before the first administration, or undefined fever>38.5 ℃ during screening/before the first administration;
• Obvious urinary tract infections and gross hematuria, indicating safety issues assessed by the investigators;
• Patients who discontinued treatment due to adverse reactions such as toxemia, systemic infection or urinary incontinence during previous BCG treatment

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07445308 · SPGL008-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗