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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01847118
• Other study ID #: SIM-63-001
• Status: Recruiting
• Phase: Phase 1
• First received: April 26, 2013
• Last updated: March 22, 2015
• Start date: April 2013
• Est. completion date: November 2015

Study information

• Verified date: July 2014
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 31
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Metastatic Solid Tumors
• Neoplasms

Intervention

Drug:
• Sevacizumab

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD)		up to 28 days	Yes
Secondary	Cmax		d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57	No
Secondary	tmax		d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57	No
Secondary	AUC		d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57	No
Secondary	t1/2		d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57	No
Secondary	Objective Response Rate (ORR)		d29, d86	No
Secondary	Disease Control Rate (DCR)		d29, d86	No