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

Sponsor
SuZhou Stainwei Biotech Inc.
Study ID
NCT03503604
Phase
PHASE1
Status
Unknown

Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • hPV19 mAb — BIOLOGICAL
    Intravenous (IV) infusions, 4 and 6 milligrams per kilogram (mg/kg) every 2 weeks
  • hPV19 mAb — BIOLOGICAL
    Intravenous (IV) infusions, 6 milligrams per kilogram (mg/kg) every 3 weeks
  • 5-Fluorouracil — DRUG
    400 mg/m2 bolus followed by a 2400 mg/m2 continuous infusion, every 2 weeks
  • Oxaliplatin — DRUG
    IV Infusion, 85 milligrams per square meter (mg/m2) every 2 weeks
  • Leucovorin — DRUG
    IV infusion, 400 mg/m2 every 2 weeks
  • Paclitaxel — DRUG
    IV infusion, 175 mg/m2 every 3 weeks
  • Carboplatin — DRUG
    IV infusion, AUC=6 every 3 weeks
  • Gemcitabine — DRUG
    IV infusion, 1000 mg/m2 at day1 and day 8 every 3 weeks
  • Carboplatin — DRUG
    IV infusion, AUC=4 every 3 weeks
  • Irinotecan — DRUG
    IV Infusion,180 milligrams per square meter (mg/m2) every 2 weeks

Study Details

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.

Key Dates

Start date
May 1, 2018
Status verified
Apr 2018
Primary completion
Jan 1, 2019
Completion
Mar 1, 2019

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: group 1
    hPV19 mAb plus FOLFOX(5-Fluorouracil,Oxaliplatin,Leucovorin)
  • Experimental: group 2
    hPV19 mAb plus paclitaxel/carboplatin
  • Experimental: group 3
    hPV19 mAb plus gemcitabine/carboplatin
  • Experimental: group 4
    hPV19 mAb plus FOLFIRI(5-Fluorouracil,Irinotecan, Leucovorin)

Primary Outcome Measure

Number of Participants That Experienced Any Dose-Limiting Toxicities (DLT) During the DLT Assessment Period [ Time Frame: during the first 21 days ]

Related Studies