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

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ClinicalTrials.gov Identifier: NCT03503604
Recruitment Status : Not yet recruiting
First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
SuZhou Stainwei Biotech Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Solid Tumors Biological: hPV19 mAb Drug: 5-Fluorouracil Drug: Oxaliplatin Drug: Leucovorin Drug: Paclitaxel Drug: Carboplatin Drug: Gemcitabine Drug: Irinotecan Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : March 1, 2019

Arm Intervention/treatment
Experimental: group 1
hPV19 mAb plus FOLFOX(5-Fluorouracil,Oxaliplatin,Leucovorin)
Biological: hPV19 mAb
Intravenous (IV) infusions, 4 and 6 milligrams per kilogram (mg/kg) every 2 weeks
Other Name: 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

Experimental: group 2
hPV19 mAb plus paclitaxel/carboplatin
Biological: hPV19 mAb
Intravenous (IV) infusions, 6 milligrams per kilogram (mg/kg) every 3 weeks
Other Name: anti-VEGF mAb

Drug: Paclitaxel
IV infusion, 175 mg/m2 every 3 weeks

Drug: Carboplatin
IV infusion, AUC=6 every 3 weeks

Experimental: group 3
hPV19 mAb plus gemcitabine/carboplatin
Biological: hPV19 mAb
Intravenous (IV) infusions, 6 milligrams per kilogram (mg/kg) every 3 weeks
Other Name: anti-VEGF mAb

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

Drug: Carboplatin
IV infusion, AUC=4 every 3 weeks

Experimental: group 4
hPV19 mAb plus FOLFIRI(5-Fluorouracil,Irinotecan, Leucovorin)
Biological: hPV19 mAb
Intravenous (IV) infusions, 4 and 6 milligrams per kilogram (mg/kg) every 2 weeks
Other Name: anti-VEGF mAb

Drug: 5-Fluorouracil
400 mg/m2 bolus followed by a 2400 mg/m2 continuous infusion, every 2 weeks

Drug: Leucovorin
IV infusion, 400 mg/m2 every 2 weeks

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




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

    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;

  2. Number of Participants With hPV19 Drug-Related Adverse Events or Serious Adverse Events [ Time Frame: Baseline to the last dose plus 28 days. ]
    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.


Secondary Outcome Measures :
  1. Number of Participants With Serum Anti-hPV19 Antibodies (Immunogenicity) [ Time Frame: before Single dose; Day 21 of 21-day DLT assessment period; Every 8 or 9 weeks after 21-day DLT assessment period. ]
  2. Maximum Concentration (Cmax) of hPV19 [ Time Frame: Single dose(Cycle 1):2h before administered; after administered 10min±5min、4h±30min、24h±1h、168h±1h、336h±1h. Other cycles: 2h before administered and after administration 10min±5min. ]
  3. Area Under the Curve (AUC) of hPV19 [ Time Frame: Single dose(Cycle 1):2h before administered, after administered 10min±5min、4h±30min、24h±1h、168h±1h、336h±1h. Other cycles: 2h before administered and after administration 10min±5min. ]
  4. Half Life (t1/2) of hPV19 [ Time Frame: Single dose(Cycle 1):2h before administered, after administered 10min±5min、4h±30min、24h±1h、168h±1h、336h±1h. Other cycles: 2h before administered and after administration 10min±5min. ]
    t1/2 is the time required for the plasma/serum concentration to decrease 50%

  5. Clearance (CL) of hPV19 [ Time Frame: Single dose(Cycle 1):2h before administered, after administered 10min±5min、4h±30min、24h±1h、168h±1h、336h±1h. Other cycles: 2h before administered and after administration 10min±5min. ]
  6. Steady State Volume of Distribution (Vss) of hPV19 [ Time Frame: Single dose(Cycle 1):2h before administered; after administered 10min±5min、4h±30min、24h±1h、168h±1h、336h±1h. Other cycles: 2h before administered and after administration 10min±5min. ]
    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

  7. Best Overall Response [Anti-Tumor Activity of hPV19 Plus Chemotherapy] [ Time Frame: Up to six months after 1st treatment or until progression of disease (PD) ]

    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.




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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503604


Locations
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China, Shanghai
Shanghai East Hospital Not yet recruiting
Shanghai, Shanghai, China, 200120
Contact: Jin Li, MD,Phd    86-13761222111    lijin@csco.org.cn   
Principal Investigator: Jin Li, Professor         
Sub-Investigator: Ye Guo, Professor         
Sponsors and Collaborators
SuZhou Stainwei Biotech Inc.

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Responsible Party: SuZhou Stainwei Biotech Inc.
ClinicalTrials.gov Identifier: NCT03503604     History of Changes
Other Study ID Numbers: STW201701B
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by SuZhou Stainwei Biotech Inc.:
mAb
VEGF
antibody
phase1

Additional relevant MeSH terms:
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Paclitaxel
Gemcitabine
Carboplatin
Oxaliplatin
Irinotecan
Fluorouracil
Bevacizumab
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Endothelial Growth Factors
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents