A Study of HLX06, a Humanized Monoclonal Antibody Targeting Human Vascular Endothelial Growth Factor Receptor-2 in Patients With Advanced Solid Tumors
NCT03494231 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2019-07-30
Summary
The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of fully human anti-VEGFR2 monoclonal antibody, HLX06, in patients with advanced or metastatic tumors refractory to standard therapy. This study will also evaluate the pharmacokinetics, pharmacodynamics, immunogenicity and anti-tumor effect of HLX06 and explore the potential prognostic and predictive biomarkers.
Conditions
- Solid Tumor, Adult
Interventions
- DRUG
-
HLX06
recombinant fully human anti-VEGFR2 monoclonal antibody against cancers
Sponsors & Collaborators
-
Henlix, Inc
lead INDUSTRY
Principal Investigators
-
Tus-Yi Chao, MD · Taipei Medical University Shuang Ho Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-03-22
- Primary Completion
- 2019-05-17
- Completion
- 2019-05-30
- FDA Drug
- Yes
Countries
- Taiwan
Study Locations
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