KCT0005756
终止
未知
A phase I study to determine the efficacy and safety of CKD-516 tablet combined with durvalumab(MEDI4736) in patient refractory solid tumors
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Asan Medical Center
- 入组人数
- 42
- 状态
- 终止
- 最后更新
- 3年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Dose Escalation Cohort (Stage 1\)
- •1\.Patients with histopathologically confirmed various tumors including CRC, pancreatic cancer, cholangiocarcinoma, stomach cancer, and esophageal cancer, with measurable or non\-measurable disease as determined by RECIST version 1\.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.
- •2\.Age \> 20 years at time of study entry
- •3\.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •4\.Must have a life expectancy of at least 12 weeks
- •5\.Body weight \>30 kg
- •6\.Adequate normal organ and marrow function as defined below:
- •?Haemoglobin \=9\.0 g/dL
- •?Absolute neutrophil count (ANC) 1\.5 (or 1\.0\) x (\> 1500 per mm3\)
- •?Platelet count \=75 x 109/L (\>75,000 / mm3\)
排除标准
- •Cohort 1 \& Cohort 2
- •:Both Dose escalation and extension cohorts, patients should not enter the study if any of the following exclusion criteria are fulfilled:
- •1\.Patients with a history of hypersensitivity to the components of study drugs
- •2\.Prior exposure to any immunotherapy
- •3\.Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) \= 14 days prior to the first dose of study drug (in case of nitrosoureas and/or mitomycin, within 6 weeks before study participation)
- •4\.Any unresolved toxicity NCI CTCAE Grade \=2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- •\-Patients with Grade \=2 neuropathy will be evaluated on a case\-by\-case basis after consultation with the Study Physician.
- •\-Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
- •5\.Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non\-cancer\-related conditions (e.g., hormone replacement therapy) is acceptable.
- •6\.Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. (in case of VATS and/or ONC surgery, within 2 weeks before study participation)
结局指标
主要结局
未指定
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