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.