A Study of Anti-VEGF Monoclonal Antibody hPV19 in Patients With Solid Tumors

Summary

hPV19 is a monoclonal antibody (mAb) directed against vascular endothelial growth factor (VEGF). hPV19 binds to human VEGF with unique binding site on VEGF different from that of Bevacizumab(Avastin) and inhibits the binding of VEGF to it's receptors, VEGF-R1 and VEGF-R2. By preventing VEGF binding to its receptors, growth of tumor blood vessels are inhibited and tumor growth prevented or slowed. In this study we are investigating the tolerability, safety, pharmacokinetics and anti-tumor activity of hPV19 in combination with chemotherapy in patients with solid tumors. hPV19 will give to patients by intravenous(i.v.) infusion with a single and multiple doses.

Conditions

• Solid Tumors

Interventions

BIOLOGICAL

hPV19 mAb

Intravenous (IV) infusions, 4 and 6 milligrams per kilogram (mg/kg) every 2 weeks

BIOLOGICAL

hPV19 mAb

Intravenous (IV) infusions, 6 milligrams per kilogram (mg/kg) every 3 weeks

DRUG

5-Fluorouracil

400 mg/m2 bolus followed by a 2400 mg/m2 continuous infusion, every 2 weeks

DRUG

Oxaliplatin

IV Infusion, 85 milligrams per square meter (mg/m2) every 2 weeks

DRUG

Leucovorin

IV infusion, 400 mg/m2 every 2 weeks

DRUG

Paclitaxel

IV infusion, 175 mg/m2 every 3 weeks

DRUG

Carboplatin

IV infusion, AUC=6 every 3 weeks

DRUG

Gemcitabine

IV infusion, 1000 mg/m2 at day1 and day 8 every 3 weeks

DRUG

Carboplatin

IV infusion, AUC=4 every 3 weeks

DRUG

Irinotecan

IV Infusion,180 milligrams per square meter (mg/m2) every 2 weeks

Sponsors & Collaborators

• SuZhou Stainwei Biotech Inc.

  lead INDUSTRY

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-01

Primary Completion

2019-01-01

Completion

2019-03-01

Countries

• China

Study Locations