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

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

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

hPV19 mAb

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

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

5-Fluorouracil

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

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

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

Jin Li, MD,Phd

Jin Li, Professor

Ye Guo, Professor

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.

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.

DLTs were adverse events (AEs) possibly related to study drug that met the National Cancer Institute's Common Terminology Criteria for AEs (NCI CTCAE, version 4.03) with any one of the following:

1. Grade 4 neutropenia ≥7 days; febrile neutropenia; grade 4 anemia; grade 4 thrombocytopenia or grade 3 thrombocytopenia with bleeding;
2. ≥ grade 3 nonhematologic toxicity with the exception of nausea, vomiting, diarrhea, dehydration or electrolyte abnormalities that resolved to a lower grade with maximum supportive treatment within 3 days;
3. ≥Grade 3 hypertension that cannot resolved to a lower grade with supportive treatment within 2 weeks or uncontrolled hypertension;
4. Urine protein ≥3.5 grams/24 hours and cannot resolved to \< 1.0 grams/24 hours within 2 weeks;
5. Gastrointestinal perforation: symptoms, signs and imaging evidence of abdominal pain require surgical treatment;
6. Grade 3 or 4 arterial thromboembolism, including stroke and myocardial infarction;

Data are presented for the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade ≥3 TEAEs, or adverse events (AEs) leading to discontinuation of treatment that were considered to be related to hPV19. Events related to chemotherapy were reported separately.

t1/2 is the time required for the plasma/serum concentration to decrease 50%

Vss is the theoretical volume in which the total amount of study drug would need to be uniformly distributed during steady state to produce the same concentration as it is in plasma/serum

Best overall response evaluated using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria.

Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Progressive Disease (PD): an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if that was the smallest on study). In addition, the sum must have demonstrated an absolute increase of at least 5 mm (the appearance of 1 or more new lesions was considered progression). Stable Disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Anti-VEGF Monoclonal Antibody hPV19 in Patients With Solid Tumors	NCT03503604	Solid Tumors	hPV19 mAb hPV19 mAb 5-Fluorouracil Oxaliplatin Leucovorin Paclitaxel Carboplatin Gemcitabine Carboplatin Irinotecan	18 Years - 75 Years	SuZhou Stainwei Biotech Inc.
A Study of Anti-VEGF Monoclonal Antibody hPV19 in Patients With Solid Tumors	NCT03503604	Solid Tumors	hPV19 mAb hPV19 mAb 5-Fluorouracil Oxaliplatin Leucovorin Paclitaxel Carboplatin Gemcitabine Carboplatin Irinotecan	18 Years - 75 Years	SuZhou Stainwei Biotech Inc.

Spots Global Cancer Trial Database for hpv19 mab

Every month we try and update this database with for hpv19 mab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hpv19 mab

Every month we try and update this database with for hpv19 mab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hpv19 mab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.