First in human study assessing the safety, immunogenicity and efficacy of the cancer vaccine IN01 as second line of treatment in RAS and BRAF mutated metastatic colorectal cancer patients

Primary objectives: Phase I:Characterize the safety, tolerability and immunogenicity of IN01 in combination with a small molecule inhibitor to confirm the recommended Phase II treatment dose and schedule
Phase II:Further assess the efficacy in the different selected mCRC genotypes based on tumour response, biomarkers and survival. Some biomarker collection and/or analysis may be limited to selected sites and patients
Primary endpoints: Phase I:• Proportion of patients achieving an anti-EGF antibody immune response• Dose limiting toxicity rates
Phase II:Objective response rate (ORR: complete and partial responses) according to RECIST 1.1