Agitam

Title

A Phase I/IIa Open-label Bridging Safety and Pharmacodynamic Study of a New Formulation of 6 month extended Dosing with AGI-101H vaccine in the Treatment of Patients with Advanced Melanoma - AGITAM


Study Objectives

  • To determine the safety profile of AGI-101H administered subcutaneous for up to 26 weeks. Induction phase (14 weeks): 8 vaccine administrations every two weeks. Maintenance phase (12 weeks): vaccine administration every 4 weeks.
  • To investigate the clinical pharmacodynamics of AGI-101H when administered in this fashion.
  • To investigate anti-tumour activity of AGI-101H when administered in this fashion.

Details

  • Protocol Number: AGI – 101H/01-2007
  • EudraCT Number: 2008-000593-20
  • Execution time: 11.2008 – 06.2010

Sponsor: AGIRx Ltd. South Essex, UK