NCT01660360

Phase I Trial of Tanibirumab in Advanced or Metastatic Cancer

A Phase I Study of the Safety and Pharmacokinetics of a Fully Human Monoclonal Antibody to the Vascular Endothelial Growth Factor Receptor2 (Tanibirumab) in Patients With Advanced Cancers or Metastatic Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: PharmAbcine · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the safety, tolerability, and maximum tolerated dose (MTD) of Tanibirumab in patients with advanced or metastatic cancer who are refractory or for whom there are no standard therapeutic option. * To evaluate the pharmacokinetics of Tanibirumab in such patients * To determine a recommended phase II dose (RP2D) of Tanibirumab based on above assessments

Detailed description

This is a Phase I, first-in-human, open-label, non-randomized, dose-escalating study of Tanibirumab which is a fully human monoclonal antibody to vascular endothelial growth factor receptor 2 (VEGFR2/KDR). This study will enroll patients with advanced or metastatic cancer who are refractory or for whom there are no standard therapeutic options. Tanibirumab will be administered intravenously to such patients over 60 minutes on Day 1, 8, and 15 (subject to change pending PK and toxicity data). Each treatment cycle will be a minimum of 28 days in length. The dose escalation study employing a 3 + 3 design is designed to identify the RP2D which will be based on safety, tolerability and PK of the RP2D. This study is expected to enroll a total of approximately 18-24 patients.

Conditions

• Advanced Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Tanibirumab

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2012-08-08
• Last updated: 2014-01-29

Locations

1 site across 1 country: South Korea