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

Suzhou Stainwei Biotech

Status and phase: Unknown; Phase 1

Conditions: Solid Tumors

Treatments: Drug: Oxaliplatin; Drug: Paclitaxel; Drug: 5-Fluorouracil; Drug: Irinotecan; Drug: Carboplatin; Drug: Leucovorin; Biological: hPV19 mAb; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03503604

STW201701B

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 4 patient groups

group 1

Experimental group

Description:

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

Treatment:

Drug: Leucovorin

Biological: hPV19 mAb

Biological: hPV19 mAb

Drug: 5-Fluorouracil

Drug: Oxaliplatin

group 2

Experimental group

Description:

hPV19 mAb plus paclitaxel/carboplatin

Treatment:

Drug: Paclitaxel

Biological: hPV19 mAb

Drug: Carboplatin

Biological: hPV19 mAb

Drug: Carboplatin

group 3

Experimental group

Description:

hPV19 mAb plus gemcitabine/carboplatin

Treatment:

Biological: hPV19 mAb

Drug: Carboplatin

Biological: hPV19 mAb

Drug: Carboplatin

Drug: Gemcitabine

group 4

Experimental group

Description:

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

Treatment:

Drug: Leucovorin

Biological: hPV19 mAb

Drug: Irinotecan

Biological: hPV19 mAb

Drug: 5-Fluorouracil