Trial | NCT03503604  Report issue

Title

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.

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    18
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.
Study Started
May 01
2018
Anticipated
Primary Completion
Jan 01
2019
Anticipated
Study Completion
Mar 01
2019
Anticipated
Last Update
Apr 20
2018

Biological hPV19 mAb

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

  • Other names: anti-VEGF mAb

Biological hPV19 mAb

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

  • Other names: anti-VEGF mAb

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

group 1 Experimental

hPV19 mAb plus FOLFOX(5-Fluorouracil,Oxaliplatin,Leucovorin)

group 2 Experimental

hPV19 mAb plus paclitaxel/carboplatin

group 3 Experimental

hPV19 mAb plus gemcitabine/carboplatin

group 4 Experimental

hPV19 mAb plus FOLFIRI(5-Fluorouracil,Irinotecan, Leucovorin)

Criteria 

Inclusion Criteria:

Confirmed malignity
Measurable disease
Performance status 2 or less(ECOG)
Life expectancy ≥3 months

Exclusion Criteria:

hepatitis C virus (HCV), or HIV antibody positive
Previously received anti-VEGF mAb or fusion-protein drugs within 28 days nearly
Evidence of serious infection
No Results Posted