A Phase 1 Study to Evaluate the Safety of OBP-301, Telomelysin in Combination With Radiation Therapy in Patients With Esophageal Cancer Not Applicable for Standard Therapy
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Incidence rate of adverse event
研究概览
简要总结
This is a phase 1 study to evaluate safety and tolerability of Telomelysin (OBP-301) in combination with radiation therapy in patient with esophageal cancer who are not applicable to standard therapy.
详细描述
After screening, patients will undergo a combination therapy of OBP-301 with radiation therapy for 6 weeks. At Day 1, Day 18 and Day 32, OBP-301 is directly injected to the location of the lesion. From Day 4, patients receive radiation therapy. Patients will be automatically entered follow-up period for 12 weeks to be observed tolerance and safety.
This study is designated as standard 3 + 3 dose escalation study. The first 3 patients will be evaluated with low-dose of OBP-301 and then the study move onto the high-dose cohort of OBP-301. When the DLT (Dose Limiting Toxicity) is observed, 3 more patients will be enrolled in the dose level.
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
- 20 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have primary tumor or metastatic lesion of histologically or cytologically diagnosed with esophageal carcinoma.
- •Patients are feasible for injection of OBP-301 into target legion
- •Patients aged in 20 to 89 years.
- •Patients with ECOG Performance Status Score ≤
- •Patient who have life expectancy longer than 12 weeks.
- •Patients who are not applicable to standard therapy.
- •Patients who have adequate organ function.
排除标准
- •Patients who have an active, treatment-required concomitant malignancy.
- •Patients who had been enrolled within 4 weeks to other clinical trials of unapproved drugs.
- •Patients who have had chemotherapy within 4 weeks.
- •Patients who have treatment history of cancer immunotherapy.
- •Patients who had radiotherapy to treatment targeted lesion.
- •Patients who have active infection which required systemic treatment.
- •Patients who are scored III or IV by NYHA (New York Heart Association).
- •Patients who are judged as inappropriate to this trial by investigator(s).
研究组 & 干预措施
OBP-301 + Radiation
OBP-301 administration on the Day 1, Day 18 and Day 32 with standard course of radiation(total 60 Gy) for 6 weeks.
干预措施: Radiation (Radiation)
OBP-301 + Radiation
OBP-301 administration on the Day 1, Day 18 and Day 32 with standard course of radiation(total 60 Gy) for 6 weeks.
干预措施: OBP-301 (Biological)
结局指标
主要结局
Incidence rate of adverse event
时间窗: 18 weeks
Incidence rate of adverse event for study period to see safety and tolerability of OBP-301 combined with radiation therapy
Occurrence of Dose Limiting Toxicity
时间窗: 18 weeks
Occurrence of Dose Limiting Toxicity for study period to see safety and tolerability of OBP-301 combined with radiation therapy
次要结局
- Tumor response in the treatment objected lesion(18 weeks)
- Tumor response(18 weeks)