NCT03503604

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

A Phase Ib Study of hPV19, a Novel Humanized Monoclonal Antibody Against Vascular Endothelial Growth Factor (VEGF),in Combination With Chemotherapy in Patients With Advanced Solid Tumors Refractory to Standard Therapy.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: SuZhou Stainwei Biotech Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2018-05-01
• Primary completion: 2019-01-01
• Completion: 2019-03-01
• First posted: 2018-04-20
• Last updated: 2018-04-20

Locations

1 site across 1 country: China