KCT0005336
Completed
未知
A Phase I Study to Assess the Safety, Tolerability and Potential Therapeutic Dose of OMT-110 in Patients with metastatic colorectal cancer
MetiMedi Pharmaceuticals0 sites12 target enrollmentTBD
ConditionsDiseases of the digestive system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the digestive system
- Sponsor
- MetiMedi Pharmaceuticals
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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