A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2062 in Patients With Solid Tumors

Официальное название

An Open-label, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Biological Effects of VG2062 in Patients With Advanced Solid Tumors.

Обзор

VG2062 is a Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection. This Phase I study will be conducted in herpes simplex virus (HSV) -seropositive subjects with advanced malignant solid tumors that are refractory to conventional therapies. This is an open label study to determine the safety and tolerability of VG2062, and recommended dose of VG2062 for Phase II trials.

Подробное описание

This is a Phase 1, open-label, dose-escalation trial using standard 3+3 dose-escalation design in patients with advanced malignant solid tumors. The trial will be conducted in multiple dosing cohorts, and evaluated for safety to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D). Dose limiting toxicity (DLT) evaluation period is for 4 weeks from the start of treatment Day 1 through Day 28.

Вмешательства

• Препарат Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection
  1. Dose level 1 2. Dose level 2 3. Dose level 3 4. Dose level 4 5. Dose level 5

Первичные конечные точки

• Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: 12 months]
• MTD/RP2D [Срок оценки: During the 28 day DLT observation period]

Вторичные конечные точки (7)

• Level of deoxyribonucleic acid (DNA) [Срок оценки: 12 months]
• ORR [Срок оценки: 12 months]
• DoR [Срок оценки: 12 months]
• DCR [Срок оценки: 12 months]
• PFS [Срок оценки: 12 months]
• OS [Срок оценки: 12 months]
• Antibodies [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Signed written informed consent form.
• Age 18 to 75 years (inclusive), male or female.
• Subject with advanced malignant solid tumors who have failed standard treatment and for whom there is no effective treatment at this stage.
• Eligible patients of childbearing potential (male and female) must agree to use a reliable method of contraception during the trial and for at least 90 days after dosing; females of childbearing potential must have a negative blood pregnancy test 7 days before enrollment.

Критерии исключения

• Subjects who have received other unlisted drugs clinical trial treatment 4 weeks before the first dose of the study drug.
• Subjects who underwent major organ surgery (excluding needle biopsy) or had significant trauma 4 weeks before the first dose of the study drug.
• In the herpes simplex virus recurrence and infection period, and there are corresponding clinical manifestations, such as oral herpes labialis, herpetic keratitis, herpetic dermatitis, genital herpes and so on.
• Other active uncontrolled infection.
• Known alcohol or drug dependence.
• Subjects with mental disorders or poor compliance.
• Women who are pregnant or breastfeeding.
• Subjects in the opinion of the investigator are not suitable for this clinical study due to other serious systemic diseases or other reasons.

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

• No. 67, Huayuan Road, Langfang Economic and Technological Development Zone, Hebei Province — Hebei

Идентификаторы

NCT: NCT07262164 · VG203-C101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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