None listed
Conditions
Interventions
Drug : One cycle is composed of a duration of 4 weeks (28 days), during which METi-101 is orally administered continuously without any interruptions.
[Phase 1b clinical trial]
Upon completing cycle 1
Sponsors
MetiMedi Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion 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 ? Renal function (1) Serum creatinine =1.5 × Upper Limit of Normal (ULN) (2) eGFR (Modification of Diet in Renal Disease, MDRD formula) =50mL/min/1.73m^2 ? Hepatic function (1) Alanine transaminase (ALT), Aspartate transaminase (AST) =5 × ULN (2) Alkaline Phosphatase (ALP) =5 × ULN (3) Total bilirubin =2 × ULN 8) Patients who have failed 2 or more palliative chemotherapies for metastatic colorectal cancer (treatment failure is defined not only as disease progression or recurrence after treatment, but also as intolerable side effects or failure to maintain treatment) 9) Voluntarily provided written consent to participate in this study 10) Patients who agree to contraception for 90 days or more for men and 30 days or more for women during the trial and after the end of the trial: ? Applicable to both female and female partners of male participants: intrauterine devices/tubal ligation for infertility purposes/combination of condoms or diaphragm with spermicide or contraceptives ? Applicable only to male participants (not applicable to male partners of female participants): condoms ? Absolute abstinence (intermittent abstinence such as during ovulation or symptothermal methods, or extracorporeal ejaculation do not apply if agreed upon as abstinence)
Exclusion criteria
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. 7) History of obstructive urological diseases such as urolithiasis or urological tumors. 8) Pregnant women, breast-feeding women or women with a positive pregnancy test at screening visit 9) Previous treatment with the investigational product 10) Treatment with other investigational product within 30 days prior to the first dose of the investigational product 11) Patients who are otherwise considered to be ineligible for this study based on investigator’s judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [Phase 2a Clinical Trial] Progression-Free Survival (PFS);[Phase 2a Clinical Trial] Overall Survival (OS);[Phase 1b Clinical Trial] Safety and tolerability (Maximum Tolerated Dose and Recommended Phase 2 Dose) | — |
Secondary
| Measure | Time frame |
|---|---|
| [Phase 1b Clinical Trial] Disease Control Rate (DCR);[Phase 1b Clinical Trial] Progression-Free Survival (PFS);[Phase 1b Clinical Trial] Duration of Response (DoR);[Phase 1b Clinical Trial] Overall Survival, OS;[Phase 2a Clinical Trial] Disease Control Rate (DCR);[Phase 2a Clinical Trial] Duration of Response (DoR);[Phase 2a Clinical Trial] Safety | — |
Countries
Korea, Republic of
Contacts
Public ContactJeong-Heum Baek
Gachon University Gil Medical Center
Outcome results
None listed