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

NCT01847118 | Unknown Phase 1

• 1 other identifier: SIM-63-001
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD)

  up to 28 days

Secondary Outcomes (6)

• Cmax

  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

• 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

• Objective Response Rate (ORR)

  d29, d86

Study Arms (1)

Sevacizumab

EXPERIMENTAL

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

Drug: Sevacizumab

Interventions

Sevacizumab DRUG

Sevacizumab

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

Study Officials

• Jin Li, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: May 6, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 24, 2015

Record last verified: 2014-07

Locations

CN (1)