Clinical

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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


ABSTRACT: 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

DISEASE(S): Colorectal Cancer Metastatic,Colorectal Cancer At A Metastatic Stage, Eligible For A Second Line Treatment And Presenting With A Constitutive Braf Or Ras Mutation

PROVIDER: 2539812 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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