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

Phase 1
18 Years
74 Years
Open (Enrolling)
Advanced Solid Tumors, Metastatic Solid Tumors

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Trial Information

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

Inclusion Criteria:

- Histologically or cytologically confirmed advanced or metastatic malignant solid

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Time Frame:

up to 28 days

Safety Issue:


Principal Investigator

Jin Li, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Food and Drug Administration

Study ID:




Start Date:

April 2013

Completion Date:

July 2014

Related Keywords:

  • Advanced Solid Tumors
  • Metastatic Solid Tumors
  • Neoplasms