A Study of Recombinant Oncolytic Virus M1(VRT106) in Patients With Solid Tumors

Официальное название

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Biodistribution Characteristics, Biological Effects and Initial Efficacy of Recombinant Oncolytic Virus M1 for Injection (VRT106) in the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors

Обзор

To Evaluate the safety and tolerability of single and multiple intratumoral injections of recombinant oncolytic virus M1 (VRT106) in patients with locally advanced/metastatic solid tumors.

Подробное описание

This study is an open-label, dose-escalation clinical study which aims to evaluate the safety and tolerability of IT injections of VRT106 in subjects with locally advanced/metastatic solid tumors, as well as evaluating the biological distribution characteristics and biological effects of VRT106 (i.e., virus tissue distribution and shedding characteristics), evaluating immunogenicity of VRT106, and preliminarily exploring the anti-tumor effects of VRT106.

Вмешательства

• Биопрепарат VRT106
  intratumoral injection

Первичные конечные точки

• Evaluate the safety and tolerability of escalating doses of intratumoral injection of VRT106. [Срок оценки: About 2 years]
• Characterize the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels. [Срок оценки: About 2 years]

Вторичные конечные точки (4)

• Examine the biological distribution characteristics and shedding patterns of intratumoral injection of VRT106. [Срок оценки: About 2 years]
• Assess the immunogenicity of intratumoral injection of VRT106. [Срок оценки: About 2 years]
• Assess the anti-tumor effect of VRT106, including objective response rate (ORR) as efficacy indicators. [Срок оценки: About 2 years]
• Assess the anti-tumor effect of VRT106, including disease control rate (DCR) as efficacy indicators. [Срок оценки: About 2 years]

Критерии участия

Критерии включения

• Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures.
• Males and females at 18-75 years of age, inclusive, at the Screening Visit.
• Subjects must have histological or cytological diagnosis of locally advanced or metastatic solid tumors who are intolerable or refractory to the standard therapy.
• Have at least one injectable lesion.
• An Eastern Cooperative Oncology Group (ECOG) score of 0-1.
• An estimated survival time of ≥ 12 weeks.

Критерии исключения

• Subject has received any anti-tumor treatment 4 weeks before using the IMP.
• Subject has received any prior oncolytic viruses or other gene therapies.
• Subject has a history of primary or acquired immunodeficient states, leukemia, lymphoma, acquired immunodeficiency syndrome (AIDS) or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy.
• Subject has received immunomodulatory drugs, including but not limited to thymosin, IL-2, IFN, etc. within 14 days prior to first administration of IMP.

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 · 3 центра

• Sun Yat-sen University Cancer Center — Гуанчжоу
• Affiliated Cancer Hospital of Zhengzhou University — Чжэнчжоу
• Affiliated Cancer Hospital of Shandong First Medical University — Цзинань

Идентификаторы

NCT: NCT06368921 · VRT106-C01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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