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

Simcere

Status and phase

Unknown

Phase 1

Conditions

Advanced Solid Tumors

Metastatic Solid Tumors

Treatments

Drug: Sevacizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01847118

SIM-63-001

Details and patient eligibility

About

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.

Enrollment

31 estimated patients

Sex

All

Ages

18 to 74 years old

Volunteers

No Healthy Volunteers

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.