Objectives
Primary Objective:
- Characterisation of the safety and tolerability of ITOP1
Secondary Objectives:
- Immunogenicity of ITOP1
- Preliminary clinical efficacy of ITOP1
Exploratory Objectives:
- Determine prevalence of target epitopes in participant samples
- Assess anti-drug antibodies dynamics
- Evaluate changes in ctDNA levels in response to treatment
- Detection of epitope-specific T cells
- Characterisation of RNA expression of tumour infiltrating T Cells
- Impact of gut microbiome on clinical outcomes/response to treatment
