None listed
Conditions
Interventions
Drug : Oral administration of SH003 for 3 weeks
1st dose group: 3 times a day, 4 tablets at a time (SH003 400mg per tablet)
2nd dose group: 3 times a day, 6 tablets at a time (SH003 400mg per tablet)
Sponsors
Kyung Hee University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - age 19 years and older - histologically or cytologically confirmed solid cancers for which standard curative measures do not exist or are no longer effective - Eastern Cooperative Oncology Group (ECOG) Performance Status =2 - estimated life expectancy of at least 12 weeks - no chemotherapy or surgery within the last 4 weeks - recovery levels of hemoglobin at =8 g/dL, platelet count =100,000/µL, and absolute neutrophil count =1,500/µL, bilirubin = 2.5 times the upper limit of normal, AST/ALT = 2.5 times the upper limit of normal, serum creatinine = 1.5 times the upper limit of normal or calculated CCr = 60mL/min - Not pregnant or consenting to birth control - the ability to swallow tablets - the ability to understand the study - willingness to sign a written informed consent document
Exclusion criteria
Exclusion criteria: - known hypersensitivity to any study drug component, including A. membranaceus, A. gigas, and T. kirilowii - with acute or chronic infections requiring treatment (active hepatitis A, B, and C viruses, human immunodeficiency virus, tuberculosis) - with uncontrolled cardiovascular diseases (unstable angina, heart failure, myocardial infarction, or uncontrolled hypertension of 140/90 mm Hg or higher) - with active cytomegalovirus infection within the past 4 weeks - with a history of major surgery for cerebrovascular disease such as acute coronary syndrome, stroke, etc., within the past year - pregnant or lactating women and those with childbearing potential - patients with any psychological, sociological, or geographical conditions that could potentially interfere with their compliance with the study protocol - patients who had participated in other clinical trials of medicine or medical devices within the past month. - patients underwent organ transplantation, including allogeneic stem cell transplantation - patients judged to have lost the ability to consent due to accompanying diseases such as dementia
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Tumor response | — |
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxocity | — |
Countries
Korea, Republic of
Contacts
Public ContactChunhoo Cheon
Kyung Hee University
Outcome results
None listed