A Phase I/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of VRT106 for Injection in Patients With Recurrent/Progressive Glioblastoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 11
- 主要终点
- Evaluate the safety and tolerability of escalating doses of VRT106 in Patients with recurrent/progressive glioblastoma
研究概览
简要总结
This study is an open-label, single-arm Phase I/II clinical trial with the primary objective of evaluating the safety, tolerability, and efficacy of VRT106 in patients with recurrent/progressive glioblastoma.
详细描述
This study is an open-label, single-arm Phase I/II clinical trial comprising two parts: Phase I and Phase II. Phase I is a dose-escalation phase, with the primary objective of assessing the safety and tolerability of VRT106 at escalating doses in subjects with recurrent/progressive glioblastoma and confirming the Recommended Phase II Dose (RP2D). Phase II is a dose-expansion phase, in which subjects will receive VRT106 at the RP2D dose level, aiming to further evaluate the efficacy and safety of VRT106 in subjects with recurrent/progressive glioblastoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily participate in the clinical study; fully understand and be informed about the study and sign the ICF; and are willing to follow and have the ability to complete all trial procedures.
- •Males and females are aged at 18-70 years (including borderline values) at the time of signing the ICF, male or female.
- •Diagnosed with recurrent/progressive glioblastoma.
- •Karnofsky Performance Status (KPS) score ≥60 within 28 days prior to the first administration of the study drug.
- •An expected survival time of≥3 months.
- •Have sufficient organ function.
- •Female patients of childbearing potential must have a negative serum pregnancy test result within 7 days prior to the first use of the study drug (if a false-positive pregnancy test result is due to non-pregnancy factors such as illness, further testing via ultrasound or other methods is required, and the investigator must confirm the absence of pregnancy before enrollment).
- •Subjects of childbearing potential (males and females) agree to use effective birth control with their partner from signing informed consent to at least 90 days after the last dose.
排除标准
- •Patients with extracranial metastases.
- •Previously received treatment with oncolytic viruses, gene therapy.
- •Subject has received treatment with other unlisted clinical investigational drugs/devices within 4 weeks prior to the first dose of VRT
- •Subject is known to have an allergic reaction to any of the components of VRT
- •Patients who can't have a cranial MRI scan.
- •Women who are breastfeeding.
研究组 & 干预措施
VRT106
VRT106 will be administered intravenously
干预措施: VRT106 (Drug)
结局指标
主要结局
Evaluate the safety and tolerability of escalating doses of VRT106 in Patients with recurrent/progressive glioblastoma
时间窗: About 2 years
To evaluate the safety and tolerability of VRT106 in patients with recurrent/progressive glioblastoma and to explore the maximum tolerated dose (MTD)/multiple ascending dose (MAD)/optimal biologically active dose (OBD) and/or the recommended phase 2 dose(RP2D), which will provide a recommended dose for subsequent clinical trials. The specific outcome indicator data that need to be evaluated and collected include: adverse event, physical examinations, vital signs, clinical laboratory tests (including blood routine, blood biochemistry.urine routine, coagulation function), Eastern Cooperative Oncology Group (ECOG) performance status, twelve-lead electrocardiogram(ECG) and concomitant medication assessments.
次要结局
- Objective response rate(About 2 years)
- Distribution and shedding of VRT106 virus(About 2 years)
- Overall survival(About 2 years)
- Overall survival rate(About 2 years)