A Phase 1 Study of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Dose Limiting Toxicity (DLT)
研究概览
简要总结
To assess the safety and tolerability of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapy
详细描述
The incidence of dose limiting toxicity (DLT) will be evaluated in cohorts of six patients by starting OCV-C02 administration at dose level 1 (OCV-103 and OCV-104 at 0.3 mg each), increasing the dose to dose level 2 (at 1 mg each), level 3 (at 3 mg each), and then up to dose level 4 (at 6 mg each). Once-weekly administration will be repeated four times in each treatment cycle, and the incidence of DLT from Day 1 to Day 29 will be evaluated.
At the end of Cycle 1, patients who wish to continue OCV-C02 treatment and have provided their written consent will be permitted to continue participation in the trial using the same dosing schedule for each subsequent cycle as that for Cycle 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have human leukocyte antigen (HLA)-A*24:02
- •Patients who have histologically-confirmed colorectal cancer (adenocarcinoma)
- •Patients with advanced or relapsed colorectal cancer who are refractory or intolerant to standard chemotherapy
- •Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 at the time of enrollment in the trial.
排除标准
- •Patients who are HIV antibody test positive
- •Patients with an active infection
- •Patients who have or are suspected to have CNS metastasis of colon cancer (such as metastatis of the brain)
研究组 & 干预措施
Dose level 1
干预措施: OCV-103 and OCV-104 (Drug)
Dose level 2
干预措施: OCV-103 and OCV-104 (Drug)
Dose level 3
干预措施: OCV-103 and OCV-104 (Drug)
Dose level 4
干预措施: OCV-103 and OCV-104 (Drug)
结局指标
主要结局
Dose Limiting Toxicity (DLT)
时间窗: Day 29
\[Definition of DLT\] Any of the following adverse events (AEs) that occurred by Day 29 of Cycle 1 and for which a causal relationship to OCV-C02 could not be ruled out: * Grade 3 or higher non-hematological toxicities (except for injection site reaction and laboratory abnormalities lasting \< 7 days without clinical symptoms) * The following hematological toxicities: Grade 4 or higher anemia, Grade 4 or higher neutropenia or lymphocytopenia lasting 7 days, Grade 3 or higher febrile neutropenia, Grade 4 or higher platelet count decreased. The severity of AEs was graded in accordance with Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Japanese version). In addition, a DLT-equivalent treatment-emergent adverse event (TEAE) was defined as a DLT occurred during the extend treatment period (at Cycle 2 and thereafter).
次要结局
- Number of Subjects With CTCAE Grade 3 or Higher TEAEs(From the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration))
- Tumor Response Rate in Cycle 1(Day 29)