KCT0008491
Recruiting
未知
An Open-label, Phase 1b/2a Clinical trial to assess the Maximum Tolerated Dose (MTD), Safety and Efficacy of METi-101 in Patients with Refractory Metastatic Colorectal Cancer
MetiMedi Pharmaceuticals0 sites30 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- MetiMedi Pharmaceuticals
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Females or males of age 19 or older at the time of consent acquisition
- •2\) Histologically or cytologically confirmed colorectal adenocarcinoma
- •3\) Patients with nonresectable metastatic lesions
- •4\) Eastern Cooperative Oncology Group Performance Status (ECOG PS) \= 2
- •5\) Patients with a life expectancy \= 12 weeks as judged by the investigator
- •6\) Patients with at least one measurable or evaluable lesion defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1\.1
- •7\) Patients who meet the following criteria at screening:
- •? Bone marrow function
- •(1\) Absolute Neutrophil Count (ANC) \=1,500/mm^3
- •(2\) Platelets \=50,000/mm^3
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\) Complications related to primary cancer that require emergency surgery according to the judgment of the investigator.
- •4\) Grade \= 3 active infection requiring intravenous antibiotics per NCI\-CTCAE version 5\.0
- •5\) History of one or more of the following cardiovascular diseases:
- •? cerebrovascular disease, unstable angina or myocardial infarction within 6 months of the screening visit.
- •? Congestive heart failure patients with New York Heart Association (NYHA) classification of Class III or higher.
- •? severe cardiac arrhythmias that cannot be controlled with medication or significant clinically abnormal cardiovascular findings as judged by the investigator
- •? QTc \>480msec (Fredericia’s formula) on 12\-lead ECG at the screening visit.
- •6\) Renal disorder or chronic renal failure requiring blood or peritoneal dialysis.
Outcomes
Primary Outcomes
Not specified
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