A Study of Anti-VEGF Monoclonal Antibody hPV19 in Patients With Solid Tumors
NCT ID: NCT03503604
Last Updated: 2018-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
18 participants
INTERVENTIONAL
2018-05-01
2019-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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group 1
hPV19 mAb plus FOLFOX(5-Fluorouracil,Oxaliplatin,Leucovorin)
hPV19 mAb
Intravenous (IV) infusions, 4 and 6 milligrams per kilogram (mg/kg) every 2 weeks
5-Fluorouracil
400 mg/m2 bolus followed by a 2400 mg/m2 continuous infusion, every 2 weeks
Oxaliplatin
IV Infusion, 85 milligrams per square meter (mg/m2) every 2 weeks
Leucovorin
IV infusion, 400 mg/m2 every 2 weeks
group 2
hPV19 mAb plus paclitaxel/carboplatin
hPV19 mAb
Intravenous (IV) infusions, 6 milligrams per kilogram (mg/kg) every 3 weeks
Paclitaxel
IV infusion, 175 mg/m2 every 3 weeks
Carboplatin
IV infusion, AUC=6 every 3 weeks
group 3
hPV19 mAb plus gemcitabine/carboplatin
hPV19 mAb
Intravenous (IV) infusions, 6 milligrams per kilogram (mg/kg) every 3 weeks
Gemcitabine
IV infusion, 1000 mg/m2 at day1 and day 8 every 3 weeks
Carboplatin
IV infusion, AUC=4 every 3 weeks
group 4
hPV19 mAb plus FOLFIRI(5-Fluorouracil,Irinotecan, Leucovorin)
hPV19 mAb
Intravenous (IV) infusions, 4 and 6 milligrams per kilogram (mg/kg) every 2 weeks
5-Fluorouracil
400 mg/m2 bolus followed by a 2400 mg/m2 continuous infusion, every 2 weeks
Leucovorin
IV infusion, 400 mg/m2 every 2 weeks
Irinotecan
IV Infusion,180 milligrams per square meter (mg/m2) every 2 weeks
Interventions
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hPV19 mAb
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
5-Fluorouracil
400 mg/m2 bolus followed by a 2400 mg/m2 continuous infusion, every 2 weeks
Oxaliplatin
IV Infusion, 85 milligrams per square meter (mg/m2) every 2 weeks
Leucovorin
IV infusion, 400 mg/m2 every 2 weeks
Paclitaxel
IV infusion, 175 mg/m2 every 3 weeks
Carboplatin
IV infusion, AUC=6 every 3 weeks
Gemcitabine
IV infusion, 1000 mg/m2 at day1 and day 8 every 3 weeks
Carboplatin
IV infusion, AUC=4 every 3 weeks
Irinotecan
IV Infusion,180 milligrams per square meter (mg/m2) every 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease
* Performance status 2 or less(ECOG)
* Life expectancy ≥3 months
Exclusion Criteria
* Previously received anti-VEGF mAb or fusion-protein drugs within 28 days nearly
* Evidence of serious infection
18 Years
75 Years
ALL
No
Sponsors
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SuZhou Stainwei Biotech Inc.
INDUSTRY
Responsible Party
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Locations
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Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Countries
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Facility Contacts
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Other Identifiers
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STW201701B
Identifier Type: -
Identifier Source: org_study_id
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