A Phase I Study to Assess the Safety, Tolerability and Potential Therapeutic Dose of OMT-110 in Patients with metastatic colorectal cancer

MetiMedi Pharmaceuticals0 个研究点目标入组 12 人开始时间: 待定最近更新: 2020年9月7日

适应症

试验速览

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•1) Male or female at least 20 years old or older at the time of informed consent
•2) Histologically or cytologically confirmed carcinoma of the Colorectal
•3) Patients who have unresectable metastatic lesion
•4) ECOG PS (Eastern Cooperative Oncology Group Performance status) = 2
•5) Patients with a life expectancy = 12 weeks as judged by the investigator
•6) At least one measurable lesion or evaluable lesion defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
•7) Voluntarily provided written consent to participate in this study

•1) History of malignancy other than metastatic colorectal cancer within 5 years prior to the first dose of investigational product (however, patients with effectively treated skin cancer, thyroid cancer, and carcinoma in situ that has been in complete remission for at least 3 years and thus considered cured by the investigator are eligible)
•2) Uncontrolled CNS metastasis (however, patients with treated and stable brain metastasis (radiographically stable for at least 30 days) are eligible)
•3) Primary cancer-related complication potentially requiring urgent surgery as judged by the investigator
•4) Grade = 3 active infection requiring intravenous antibiotics per NCI-CTCAE version 5.0
•5) Pregnant women, breast-feeding women or women with a positive pregnancy test at screening visit (Visit 1)
•6) Previous treatment with the investigational product
•7) Treatment with other investigational product within 30 days prior to the first dose of the investigational product
•8) Patients who are otherwise considered to be ineligible for this study based on investigator’s judgment

发起方

MetiMedi Pharmaceuticals