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

NCT ID: NCT01847118

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-11-30

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.

Conditions

Advanced Solid Tumors; Metastatic Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sevacizumab

2mg/kg、5mg/kg、7.5mg/kg、10mg/kg、12.5mg/kg、or 15mg/kg. d1, d29, d43, d57

Group Type: EXPERIMENTAL

Sevacizumab

Intervention Type: DRUG

Interventions

Sevacizumab

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jin Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Jin Li, MD, PhD

Role: primary

86-021-61733905

Other Identifiers

SIM-63-001

Identifier Type: -

Identifier Source: org_study_id