Advanced Malignant Solid Tumor
Conditions
Interventions
Group 1:0.5mg/m^2/day (single-dose observation for 7 days
multi-dose d1-d5, d8-d12, d15-d19 administration, every 4 weeks as a cycle)
Group 2:1 mg/m^2/day (single-dose observation for 7 days
multi-dose d1-d5, d8-d12, d15-d19 administration, one cycle every 4 weeks)
Group 3:2 mg/m^2/day (single-dose observation for 7 days
Group 4:4 mg/m^2/day (single-dose observation for 7 days
Group 5:6.7 mg/m^2/day (single-dose observation for 7 days
Group 6:10 mg/m^2/day (single-dose observation for 7 days
Group 7:13.3 mg/m^2/day (single-dose observation for 7 days
Group 8:17.7 mg/m^2/day (single-dose observation for 7 days
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. No gender limit, subjects/patients aged 18-65 years. 2. Histologically or cytologically confirmed advanced solid tumors (including pancreatic, liver, bile duct, colorectal cancer, with pancreatic cancer being preferred) that fail to respond to standard therapies and develop disease progression. 3. Identify at least one measurable lesion that meets the requirements of RECIST version 1.1; If the lesion that has previously received local treatment (radiotherapy, ablation, vascular intervention, etc.) is the only lesion, there must be a clear imaging basis for disease progression in that lesion. 4. The physical condition score of the Eastern Oncology Consortium (ECOG) was 0-2. 5. Laboratory results within 14 days prior to initial receipt of the investigational drug shall meet the following criteria: (1) Hematology: blood neutrophil count ANC >=1.5x10^9/L, platelet count >=100x10^9/L, hemoglobin >= 90 g/L (no blood transfusion, no use of blood products, no use of granulocyte colony stimulating factor or other hematopoietic stimulating factors 14 days before laboratory examination); (2) Liver function: serum total bilirubin =50 mL/min (calculated according to Cockcroft-Gault formula); (4) Urine protein =2+, 24-hour urinary protein quantity should be <1 g; (5) Coagulation function: International standardized ratio (INR) <=1.5 and partial activated prothrombin time (APTT) <=1.5xULN. 6. Expected survival is at least 3 months. 7. Serum pregnancy test is negative (if female). 8. Female subjects/patients of reproductive age or male subjects/patients with partners of women of reproductive age should use effective contraceptive methods, such as double screen contraceptive methods, condoms, intrauterine devices, abstinence, etc., from at least one month before the first study drug to six months after the last study drug. 9. Have fully understood this study and voluntarily signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Toxicity of previous antitumor therapy has not recovered =140 mmHg and/or diastolic blood pressure >=90 mmHg); 10. Present active infection, or unexplained fever (body temperature >38.5?) that occurred during screening or prior to first receiving the study drug; 11. There are active gastric and duodenal ulcers, ulcerative colitis and other gastrointestinal diseases, or active bleeding in unresectable tumors, or other conditions that researchers have determined may cause gastrointestinal bleeding and perforation; 12. Patients with evidence or history of thrombosis or significant bleeding tendency within 2 months before receiving the study drug for the first time (bleeding >30 mL within 2 months, hematemesis, black feces, blood in the stool), hemoptysis (fresh blood >5 mL within 4 weeks); 13. Arterial thrombosis or deep vein thrombosis occurred within 6 months before first receiving the study drug; Or thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months; 14. Have active tuberculosis, are receiving anti-TB treatment, or received anti-TB treatment within 1 year before first receiving the study drug; 15. Previous and current history of pulmonary fibrosis and interstitial pneumonia were deemed unsuitable for this study by the researchers; 16. A known history of clinically significant liver disease, including hepatitis B virus (HBV) DNA>1×10^3 copies /mL or >200 IU/mL when infected with active viral hepatitis [h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity (DLT);Maximum tolerated dose(MTD);Recommended phase II dose (RP2D); | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation index;PK parameter; | — |
Countries
China
Contacts
Public ContactYu Xianjun, Zhang Jian
Fudan University Shanghai Cancer Center
Outcome results
None listed