Overview

A Phase Ia, Dose Escalation Study of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in Patients With Advanced or Metastatic Solid Tumors

Status:
Unknown status
Trial end date:
2015-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Treatments:
Antibodies
Antibodies, Monoclonal
Bevacizumab
Criteria
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.