MedTrace Logo

Pharmacokinetics and Tolerancebility Studies of Gentuximab Injection in the Treatment ofPatients With Late Recurrence of Metastatic Solid Tumors in China

NCT03313219 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-12-12

No results posted yet for this study

Summary

The primary objective is to evaluate the safety and, tolerabilitytolerance, pharmacokinetices and immunogenicity of escalating single doses and subsequent multiple dose of Gentuximab Injection in patients with late recurrence of metastatic solid tumors and to determine the maximum tolerated dose（MTD） and dose limiting toxicities（DLT）.with single and subsequent multiple intravenous infusion in patients with late recurrence of metastatic solid tumors and to provide a basis for the protocol design of later clinical trials.

The secondary objective is to evaluate the pharmacokinetics, pharmacodynamics and immunogenicity, and tumor response of multiple dose of Gentuximab Injection in patients with late recurrence of metastatic solid tumors.

Conditions

Interventions

DRUG

Gentuximab Injection

Gentuximab Injection (Recombinant anti-VEGFR2 human-mouse chimeric monoclonal antibody injection)

Sponsors & Collaborators

  • Shanghai East Hospital

    collaborator OTHER

  • Changchun GeneScience Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jin Li · Ethics Committee of Drug Clinical Trials

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-11
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03313219 on ClinicalTrials.gov