Clinical trial NCT03503604: A Study of Anti-VEGF Monoclonal Antibody hPV19 in Patients With Solid Tumors
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Solid Tumors
Keywords: mAb
VEGF
antibody
phase1
Lead sponsor: SuZhou Stainwei Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants That Experienced Any Dose-Limiting Toxicities (DLT) During the DLT Assessment Period
timeFrame: during the first 21 days
measure: Number of Participants With hPV19 Drug-Related Adverse Events or Serious Adverse Events
timeFrame: Baseline to the last dose plus 28 days.
Secondary outcomes:
measure: Number of Participants With Serum Anti-hPV19 Antibodies (Immunogenicity)
timeFrame: before Single dose; Day 21 of 21-day DLT assessment period; Every 8 or 9 weeks after 21-day DLT assessment period.
measure: Maximum Concentration (Cmax) of hPV19
timeFrame: 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.
measure: Area Under the Curve (AUC) of hPV19
timeFrame: 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.
measure: Half Life (t1/2) of hPV19
timeFrame: 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.
measure: Clearance (CL) of hPV19
timeFrame: 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.
measure: Steady State Volume of Distribution (Vss) of hPV19
timeFrame: 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.
measure: Best Overall Response [Anti-Tumor Activity of hPV19 Plus Chemotherapy]
timeFrame: Up to six months after 1st treatment or until progression of disease (PD)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
Study officials:
References: