Advanced solid tumor
Conditions
Interventions
0.5mg group:C0D1 Take about 240ml of warm water in the morning to take 0.5mg orally on an empty stomach
3mg group:C0D1 is taken once, C1D1-C1D21 is taken continuously.....CND21. Both are taken with about 240mg of warm water in the morning to take 3mg of medicine
6mg group:C0D1 is taken once, C1D1-C1D21 is taken continuously.....CND21. Both are taken with about 240mg of warm water in the morning to take 6mg of medicine
12mg group:C0D1 is taken once, C1D1-C1D21 is taken continuously.....CND21. Both are taken with about 240mg of warm water in the morning to take 12mg of medicine
18mg group:C0D1 is taken once, C1D1-C1D21 is taken continuously.....CND21. Both are taken with about 240mg of warm water in the morning to take 18mg of medicine
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in this study and sign an informed consent form; 2. Aged 18 to 75 years old (including cut-off value); 3. Patients with advanced solid tumors who are confirmed by histology or cytology without standard treatment plan or who are ineffective or intolerant to standard treatment plan; 4. Agree to provide tumor tissue or blood samples for exploratory research of JRF103 gene biomarkers; 5. Eastern Cooperative Oncology Group (ECOG) score: 0~1; 6. The estimated survival period >=12 weeks; 7. According to the RECIST v1.1 standard, there is at least one measurable lesion; 8. Within 7 days before using the study drug, the laboratory inspection meets the following standards: (1) In the 14 days before the administration of the study drug, if you have not received such as blood transfusion, erythropoietin (EPO), granulocyte colony stimulating factor (G-CSF), platelet-increasing therapy or other medical support, the blood routine examination standard: Hemoglobin (HB) >=90 g/L; Absolute neutrophil count (ANC) >=1.5x10^9/L; Platelet count (PLT) >=90x10^9/L; (2) Blood biochemical liver function test standards: Total bilirubin (TBIL)=60ml/min; (4) Coagulation function inspection standard: International normalized ratio (INR) or prothrombin time (PT)<=1.3 ULN; partially activated thromboplastin time (aPTT)<=1.5 ULN; 9. Males with fertility and females of childbearing age must agree to take reliable contraceptive measures from the signing of the informed consent form until 180 days after the last administration of the study drug. Women of childbearing age include premenopausal women and women within 2 years after menopause. Women of childbearing age must have a negative blood pregnancy test within 7 days before the first study drug administration.
Exclusion criteria
Exclusion criteria: 1. Allergic physique, or a history of severe allergies in the past, or known allergies to the ingredients of the study drug; 2. Received chemotherapy, radiotherapy, hormone therapy, immunotherapy, targeted therapy, biological therapy or other clinical research drug treatments within 4 weeks before taking this study drug for the first time, and received within 6 weeks before taking this study drug for the first time After mitomycin and nitrosourea therapy (except for local palliative radiotherapy, prednisone less than 10 mg); 3. Have previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation, or plan to receive allogeneic hematopoietic stem cell transplantation or solid organ transplantation during the study period; 4. Unable to swallow the drug or suffering from gastrointestinal diseases or other malabsorption conditions that affect the absorption of the drug, such as intestinal obstruction, Crohn's disease, ulcerative colitis; or severe gastrointestinal tract before taking the drug for the first time Relevant toxicity and did not return to below grade 2; or confirmed to have clinically significant or acute gastrointestinal disease, manifested as diarrhea and/or colitis as the main symptoms (including acute enteritis, malabsorption or other causes of grade 2 or Diarrhea above); 5. Patients with primary central nervous system tumors or central nervous system metastases (except for those who are stable and asymptomatic for at least 4 weeks before the first administration, and do not need systemic corticosteroids or any Anticonvulsant therapy); 6. Women during pregnancy and lactation; 7. Past history of interstitial lung disease, pulmonary fibrosis, drug-induced interstitial lung disease or radiation pneumonia; 8. Evidence shows that the investigator believes that he has serious or uncontrollable liver disease or kidney disease; 9. Eye diseases with obvious symptoms, including but not limited to corneal ulcer, keratitis, conjunctivitis, etc.; 10. Grade >=2 skin rashes, mucositis, skin infections or ulcers that need to be treated, or there is currently >=grade 2 skin toxicity caused by previous treatment; 11. Suffer from clinically significant cardiovascular diseases, including but not limited to: (1) Previously or currently suffering from myocardial ischemia or myocardial infarction, unstable angina pectoris, and New York Heart Association heart function classification III-IV heart failure; (2) Patients with prolonged ECG QT/QTc interval at baseline (QTcF: male>450ms, female>470ms); or those with a history of hereditary long QT syndrome; (3) Baseline echocardiography (ECHO) shows left ventricular ejection fraction (LVEF) =140mmHg, diastolic blood pressure >=90mmHg); (5) Past medical history of cardiac surgery such as angioplasty and coronary artery bypass graft; 12. Have a clear history of neurological or mental disorders, including epilepsy or dementia; 13. Hepatitis B surface antigen (HBsAg) positive and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) titer test is higher than the upper limit of normal or HCV antibody is positive and HCV RNA is higher than the upper limit of normal; or HIV antibody, syphilis antibody is positive; 14. Have active infection within 2 weeks before taking the drug for the first time; 15. Suffer from unstable, uncontrolled active bleeding dise
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety observation indicators include: vital signs, physical examination, clinical laboratory examination, 12-lead ECG examination, echocardiography, ECOG score, adverse events, etc.;Efficacy evaluation indicators: objective response rate (ORR), duration of response (DOR), disease control rate (DCR), progression-free survival (PFS);PK parameters: Cmax, Tmax, t1/2, Vd, CL, AUC0-24h, AUC0-t, AUC0-8, Rac.; | — |
Countries
China
Contacts
Public ContactYongsheng Wang
West China Hospital, Sichuan University
Outcome results
None listed