A Phase I, Multicenter, Open-label, Dose Escalation Study of Intratumoral Injections of VCN-01 Oncolytic Adenovirus With Intravenous Gemcitabine and Abraxane® in Advanced Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- Recommended Phase 2 Dose (RP2D) of VCN-01 in combination with Gemcitabine and Abraxane® by determination of highest feasible dose (MFD) and any Dose Limiting Toxicities
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of three intratumoral injections of VCN-01 combined with Abraxane®/gemcitabine, and to determine the recommended phase II dose of VCN-01 combined with Abraxane®/gemcitabine.
详细描述
Investigational treatment is a dose-escalation regimen consisting of three VCN-01 intratumoral injections (once every 28 days at the same dose) in combination with intravenous Abraxane® and gemcitabine.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/Female patients aged 18 years or over
- •Patients must provide written informed consent
- •Life expectancy above 3 months
- •Patients willing to comply with treatment follow-up, and to accept a biopsy at day 29 after initiation of the treatment
- •Patients with histologically confirmed diagnosis of unresectable pancreatic adenocarcinoma with symptoms related to the primary tumor. Abraxane® plus Gemcitabine should be the appropriate standard of care to be administered.
- •ECOG Performance status 0 or 1
- •Adequate baseline organ function (hematologic, liver, renal and nutritional)
- •Use a reliable method of contraception in fertile men and women
排除标准
- •Active infection or other serious illness or autoimmune disease
- •Treatment with live attenuated vaccines in the last three weeks
- •Known chronic liver disease (liver cirrhosis, chronic hepatitis)
- •Treatment with another investigational agent within its five half-lives prior to VCN-01 infusion
- •Viral syndrome diagnosed during the two weeks before inclusion
- •Chronic immunosuppressive therapy
- •Known concurrent malignant hematologic or solid disease
- •Pregnancy or lactation. Patients must agree to use effective contraception or be surgically sterile.
- •Patients receiving full-dose anticoagulant / antiplatelet therapy
- •Patients with Li Fraumeni syndrome or with previous known retinoblastoma protein pathway germinal deficiency
研究组 & 干预措施
Dose Escalation, Combination
Three intratumoral administrations of VCN-01 oncolytic adenovirus every 28 days in combination with Abraxane® and Gemcitabine.
干预措施: VCN-01 (Genetic)
Dose Escalation, Combination
Three intratumoral administrations of VCN-01 oncolytic adenovirus every 28 days in combination with Abraxane® and Gemcitabine.
干预措施: Gemcitabine (Drug)
Dose Escalation, Combination
Three intratumoral administrations of VCN-01 oncolytic adenovirus every 28 days in combination with Abraxane® and Gemcitabine.
干预措施: Abraxane® (Drug)
结局指标
主要结局
Recommended Phase 2 Dose (RP2D) of VCN-01 in combination with Gemcitabine and Abraxane® by determination of highest feasible dose (MFD) and any Dose Limiting Toxicities
时间窗: At least 6 months
Safety and Tolerability by means of Adverse Events (AEs) and laboratory data
时间窗: At least 6 months
次要结局
- Presence of VCN-01 in tumor(Day 21-28)
- Viral Pharmacokinetics(48 h)
- Viral Shedding(Up to day 71)
- Neutralizing antibodies anti-VCN-01(30 days after end of treatment phase)
- Preliminary anti-tumor activity by Overall Response Rate (ORR)(CT or MRI scans every 8 weeks until disease progression)
- Preliminary anti-tumor activity by Progression Free Survival (PFS)(CT or MRI scans every 8 weeks until disease progression)