A Phase 1, Open Label, Dose Finding Study to Assess the Safety and Tolerability of IMCgp100, a Monoclonal T Cell Receptor Anti-CD3 scFv Fusion Protein in Patients With Advanced Malignant Melanoma
IMCgp100 is a bispecific biologic incorporating an engineered T cell receptor (TCR) specific
for a peptide antigen derived from the protein gp100 presented in the context of HLA A2 on
the surface of melanoma cells. The TCR is fused to an anti-CD3 scFv fragment that recruits
and activates non-melanoma specific T cells (killer T cells) in physical contact with the
cancer T cell. This is a Phase I study designed to assess the safety profile and establish a
tolerable dose of IMCgp100 in HLA A2 positive malignant melanoma patients. In the second
part of the trial, patients will receive an extended course of treatment with a view to
assessing the effect of the drug on disease. Patients in the dose escalation phase may also
be offered repeat treatment with a dose that has been demonstrated to be tolerable.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Definition of the maximum tolerated dose and evaluation of the safety and tolerability of multiple injections of IMCgp100
The outcome measure of part 1 of the trial is the definition of the maximum tolerated dose based on dose limiting toxicity and pharmacokinetics in patients with stage IV or stage III unresectable malignant melanoma. The outcome measure of part 2 of the trial is the evaluation of the safety and tolerability of IMCgp100 following multiple IV administrations of IMCgp100 given at the dose recommended from part 1 of the study.
Yvonne McGrath, PhD
United Kingdom: Medicines and Healthcare Products Regulatory Agency
|Mary Crowley Cancer Research Center||Dallas, Texas 75246|