To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2

Официальное название

An Single-arm, Multicenter Phase I/II Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2

Обзор

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2

Подробное описание

This is a single-arm, multicenter phase I/II clinical study to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2.

Вмешательства

• Препарат Disitamab Vedotin for injection
  Intravesical instiliations into the bladder

Первичные конечные точки

• Incidence of dose-limiting toxicity(DLT) (Phase I) [Срок оценки: Approximately 21 days]
• Incidence of Adverse event (Phase I) [Срок оценки: Approximately 1 years]
• Recommended Phase II Dose(RP2D) [Срок оценки: Approximately 21 days]
• Maximum Tolerated Dosage(MTD) [Срок оценки: Approximately 21 days]

Вторичные конечные точки (5)

• Disease-free survival (DFS) rates [Срок оценки: Up to approximately 2 years]
• Duration of response (DOR) [Срок оценки: Up to approximately 2 years]
• Disitamab Vedotin anti-drug antibody (ADA) [Срок оценки: Up to approximately 2 years]
• PK of enfortumab vedotin: Maximum concentration (Cmax) [Срок оценки: Approximately 1 years]
• PK of enfortumab vedotin: Trough concentration (Ctrough) [Срок оценки: Approximately 1 year]

Критерии участия

Критерии включения

• Voluntary consent to participate in the study and signed the informed consent form.
• Male or female, age 18-75 years (including both).
• Histologic confirmed non-muscle invasive bladder urothelial carcinoma (NMIBC), and the risk group met the high-risk (including very high-risk) group.

Note: High-risk NMIBC is a high-grade / G3 tumor meeting any of the following:

a.Carcinoma in situ (CIS) b. T1 stage c. diameter>3cm d.Multiple tumors, or recurrent tumors.

• Absence of resectable disease（Ta and/or T1 disease） after transurethral resection (TURBT) procedures (residual CIS acceptable;
• The urologist assessed that radical surgery for bladder cancer was not suitable or the subject refused radical surgery for bladder cancer.
• Tumor tissue samples were detected by immunohistochemistry (IHC) to satisfy HER2 expression of 1+, 2+ or 3+.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Adequate heart, bone marrow, liver, kidney and coagulation function

Критерии исключения

• 1\. Invasive bladder cancer (T2 and above) and / or with regional lymph node and distant metastasis.

2\. Combined urothelial carcinoma outside the bladder (i. e., urethra, ureter or renal pelvis).

3\. Any other antitumor therapy received within 4 weeks before study administration, .

4 Subjects plan to undergo major surgery during the study or within 4 weeks before the first dose.

5, Known allergic to DV and its components or to any excipients.

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 · 6 центров

• Sun Yat-sen Memorial Hospital,SunYat-sen University — Гуанчжоу
• Tongji Hospital — Ухань
• Hunan Cancer hospital — Чанша
• The first affiliated hospital with nanjing medical universtity — Нанкин
• West China Hospital — Чэнду
• Tianjin Medical University Second Hospital — Тяньцзинь

Публикации

• Chen X, Huang M, Chen Z, Zhang C, Pan B, Liu C, Xu W, Fang J, Huang J, Lin T. Intravesical Disitamab Vedotin (RC48) for HER2-Expressing High-Risk Non-Muscle-Invasive Bladder Cancer: A Single-Arm, Dose-Escalation Phase I Trial Study. MedComm (2020). 2025 Jul 13;6(7):e70288. doi: 10.1002/mco2.70288. eCollection 2025 Jul. PMID 40661136

Идентификаторы

NCT: NCT06378242 · RC48-C029

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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