Advanced Solid Tumors
Conditions
Keywords
Advanced Solid Tumors
Brief summary
This study is dose-escalation open-label study to determine the MTD of M2ES in Subjects With Advanced Solid Tumors the recommended Phase II dose.The recommended dose and regimen of M2ES will be selected to perform the pharmacokinetic study profiles.
Detailed description
This study is a Phase I dose-escalation open-label study to determine the MTD of M2ES in Subjects With Advanced Solid Tumors the recommended Phase II dose.The recommended dose and regimen of M2ES will be selected to perform the pharmacokinetic study profiles.
Interventions
Sponsors
Protgen Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 18 to 60 years of age 2. patients had histologically or cytologically confirmed solid tumors that was refractory to standard therapy. 3. life expectancy of at least 3 months. 4. ECOGPS ≤ 1 5. Adequate hematologic, renal, and hepatic function was required as determined by the following: WBC ≥4×109/L, absolute neutrophil count ≥ 1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥ 9g/dL, total bilirubin ≤1.5 upper limit of normal \[ULN\],AST ≤ 2.5 ULN, or ≤ 5 ULN if there was evidence of liver metastases; alkaline phosphatase ≤ 2.5 ULN, or ≤ 5 ULN if there was evidence of liver Metastases; creatinine clearance ≥50 mL/min.
Exclusion criteria
1. Pregnant and latent women, no contraception for women of childbearing age 2. Have taken other treatments 3. Be allergic to endostatin and other ingredient 4. Gastrointestinal Hemorrhage 5. Have Participated any clinical trail during the last 4 week 6. ECG: QTC ≥ 480 ms 7. patients had clinically apparent CNS disease ( primary brain tumors, tumor related apoplexy, CNS metastases, carcinomatous meningitis.) 8. Cardiovascular and mental disease 9. HIV-1 infected 10. HBV, HBV infected ,Hepatitis B surface antigen positive 11. Patients on therapeutic doses of heparin or antiplatelet agents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The maximum tolerate dosage | 4 weeks | The maxium tolerate dosage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) behavior of M2ES in tumor subject | 4 week | Pharmacokinetic (PK) behavior of different doses of M2ES in Subjects With Advanced Solid Tumors |
| The incidence rate of adverse event | 4 weeks | The incidence rate of adverse event |
Countries
China
Contacts
Primary ContactSu LI, PhD
Outcome results
None listed