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
Total number of patients: 20 evaluable patients will be enrolled in the study.
Dosage: 5 x 107 live cells. No dose modification is planned.
Administration: Subcutaneous (s.c.)
Duration of treatment: Patients will receive treatment for up to 26 weeks. Progression at
any time point requiring systemic treatment with, for example with chemotherapy or cytokines
will lead to withdrawal of this patient from the study. All surviving patients of this
AGITAM trial will be offered the opportunity to transfer to a follow-up treatment protocol
with AGI - 101H. In this case treatment may continue every 4 - 8 weeks until progression or
death or withdrawal unless such therapy is contraindicated or patient does not wish to
Reference therapy: Not applicable.
Description of medicinal product: The drug substance, AGI-101H, is a whole cell, allogeneic
melanoma vaccine, representing a mixture (1:1 ratio) of two therapeutic genemodified human
melanoma cell lines, referred to as Mich1H6 and Mich2H6, which has been gamma-irradiated to
render the cells non-proliferative. There is no recommended International Non-proprietary
(INN) Name for the drug substance.
Methodology: In this open-label study of patients with advanced melanoma, one dose of AGI -
101H vaccine will be administered s.c.. 20 evaluable patients will be recruited. An
independent data monitoring committee (DMC) will review all safety data after the first 10
injections and then after another 10 injections (20 injections in total). Up to that second
DMC meeting all patients have to stay in the hospital for a 2 hours observation; after the
analysis of the 20 vaccinations the DMC will review the safety data and may recommend
reverting to normal outpatients setting.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
The safety profile of AGI-101H
AGIRx (Active Gene Interventions) Ltd
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
AGI - 101H/01-2007