Advanced Solid Tumors, Metastatic Solid Tumors
Conditions
Brief summary
This study is to assess the safety, tolerability and pharmacokinetics of single dose and multiple doses of humanized anti-VEGF monoclonal antibody (Sevacizumab) in patients with advanced or metastatic solid tumors. The secondary objective is to explore the preliminary anti-tumor effects.
Interventions
DRUGSevacizumab
Sponsors
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed advanced or metastatic malignant solid tumors; * Patients failed the standard anti-tumor therapy or don't have standard regimen; * At least one measurable lesion; * At least 4 weeks from the last chemotherapy, 6 weeks from mitomycin, and nitrosourea treatment. If patients received anti-tumor biological products, at least four t1/2 of washout period is needed; * Toxicity from previous treatment has to restore to ≤ grade 1 (NCI CTC4.0); * ECOG performance status 0-1; * Life expectancy ≥ 3 months; * Adequate hematologic function: ANC ≥ 1.5 × 10\^9 /L, HB ≥ 90 g /L (blood transfusion allowed), PLT ≥ 100 × 10\^9 /L; * Adequate hepatic function: ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN, TBIL ≤ 1.5 × ULN (patients with liver metastases ALT ≤ 5 × ULN, AST ≤ 5 × ULN, TBIL ≤ 3 × ULN); * Adequate renal function: creatinine ≤ 1 × ULN; * Coagulation function: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN; * Patients of childbearing potential (male and female) must agree to use reliable methods of contraception until at least 12 weeks after the last dose.
Exclusion criteria
* HCV, TP or HIV antibody positive; * Previously received anti-VEGF protein drugs, such as bevacizumab; * Histologically proven squamous cell lung cancer or squamous cell carcinoma of the head and neck; * Active hepatitis B infection; * Evidence of serious infection; * Symptomatic brain metastases; * Patients with proteinuria at screening (urine protein ≥ 1+); * History of abdominal fistula, gastrointestinal perforation, abdominal abscess within 6 months prior to enrollment; * Serious non-healing wounds, ulcers or fractures; * Major surgery (excluding biopsy) or significant trauma within 4 weeks prior to enrollment; * Active bleeding within 3 months prior to enrollment; * Bleeding diathesis or coagulation disorder; * History of arterial or venous thrombosis; * History of myocardial infarction or stroke within 6 months prior to enrollment; * Unstable angina, congestive heart failure, New York Heart Association (NYHA) class II heart failure, uncontrollable arrhythmia, uncontrolled hypertension (systolic blood pressure\> 150 mmHg and/or diastolic blood pressure\> 100 mmHg); * Pregnant and lactating women; * Known allergies to any excipient in the study drug; * Patients with alcohol or drug dependence; * Participation in other clinical trials within 4 weeks before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose (MTD) | up to 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR) | d29, d86 |
| Cmax | d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57 |
| Objective Response Rate (ORR) | d29, d86 |
| AUC | d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57 |
| t1/2 | d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57 |
| tmax | d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57 |
Countries
China
Outcome results
None listed