NCT03313219

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

Pharmacokinetics and Tolerabilitynce Studies of Gentuximab (Recombinant Anti-VEGFR2 Human-mouse Chimeric Monoclonal Antibody) Injection in the Treatment of Late Recurrence of Metastatic Solid Tumors in China: An Open-label，Non-randomised，Uncontrolled，Dose-escalation，Single Center，Pphase Ia Study in Patients With Late Recurrence of Metastatic Solid Tumors in China

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The safety profile of Gentuximab Injection will be explored together with the pharmacokinetics, pharmacodynamics and tumour response to treatment with Gentuximab Injection to recommend the dosing regimen for further clinical studies. The pharmacokinetic properties of Gentuximab Injection will be evaluated after single and multiple dose administrations at different dose levels.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Gentuximab Injection	Gentuximab Injection (Recombinant anti-VEGFR2 human-mouse chimeric monoclonal antibody injection)

Timeline

• Start date: 2017-10-11
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2017-10-18
• Last updated: 2017-12-12

Locations

1 site across 1 country: China