A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)

Обзор

This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle invasive bladder cancer.

Вмешательства

• Препарат SHR-2005
  In dose Escalation: Four dose levels are preset. The administration cycle included 6 times of induction perfusion period and 15 times of maintenance perfusion period. In indication Expansion: Indications will be selected to evaluate preliminary efficacy.

Первичные конечные точки

• Incidence of dose limiting toxicities (DLTs) [Срок оценки: From Day 1 to Day 21]
• Maximum tolerated dose (MTD) [Срок оценки: From Day 1 to Day 21]
• Incidence and severity of adverse events (AEs) ([CTCAE] v5.0) [Срок оценки: From Day 1 to 90 days after last dose]
• RP2D（Recommended Phase 2 dose） [Срок оценки: From Day 1 to 90 days after last dose]

Вторичные конечные точки (8)

• PK parameter: Tmax of SHR-2005 [Срок оценки: approximately 24 months]
• PK parameter: Cmax of SHR-2005 [Срок оценки: approximately 24 months]
• PK parameter: AUC0-∞ of SHR-2005 [Срок оценки: approximately 24 months]
• Immunogenicity of SHR-2005 [Срок оценки: approximately 24 months]
• Duration of response (DoR) [Срок оценки: approximately within 36 months]
• Disease control rate (DCR) [Срок оценки: approximately within 36 months]
• Progression-free survival (PFS) [Срок оценки: approximately within 36 months]
• Amount_recovered and Percent_recovered [Срок оценки: approximately 24 months]

Критерии участия

Критерии включения

• Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
• ≥18 years of age, either sex;
• Previous pathological biopsy was diagnosed as intermediate or high-risk NMIBC ;
• ECOG performance status of 0-1;
• Life expectancy ≥ 2 years;
• Adequate bone marrow and organ function.

Критерии исключения

• Received TURBT or other surgical treatment or radiotherapy for bladder lesions within 2 weeks before the first administration;
• Patients who were receiving treatment in other clinical trials or less than 4 weeks from the end of the first administration in this study;
• History of serious cardiovascular and cerebrovascular diseases;
• Severe infection within 2 weeks prior to the first dose;
• Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0;
• Oversize surgery or severe trauma within 4 weeks before the first use of research drugs;
• Previously received any TNFR agonist antibody therapy, such as OX40, CD137, CD27, CD357 antibodies.

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

Китай · 1 центр

• Fudan University Zhongshan Hospital — Шанхай

Идентификаторы

NCT: NCT06108492 · SHR-2005-I-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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