A Screening Study Targeting Tumor-specific Antigens

ADVANCED/METASTATIC COLORECTAL CANCER Inclusion Criteria: * signed and dated ICF prior to initiation of study-specific procedures * histologically confirmed metastatic CRC who are planned for or who have received no more than one cycle of first-line treatment in the advanced/metastatic setting with a fluoropyrimidine and oxaliplatin in combination with bevacizumab * measurable and unresectable disease according to RECIST v1.1 * known KRAS status * availability of FFPE tumor specimens from biopsy within the previous 12 months for sequencing and neoantigen prediction * ≥ 12 years of age * ECOG performance status of 0 or 1 or equivalent for patients of 12-17 years of age * adequate organ function (further defined in protocol) Exclusion Criteria: * known microsatellite instability (MSI)hi disease based on institutional standard * known tumor mutation burden \<1 nonsynonymous mutations/MB * patients with BRAF V600E mutations LOCALIZED COLON CANCER Inclusion Criteria: * signed and dated ICF prior to initiation of study-specific procedures * high-risk stage II or stage III colon cancer planned for or have completed surgical resection and have not initiated or received more than 4 weeks of adjuvant chemotherapy and be known ctDNA-positive via the Signatera assay * availability of FFPE tumor specimens for sequencing, determination of mutations for detecting and monitoring ctDNA to identify patients with minimal residual disease, and neoantigen prediction * ≥ 12 years of age * ECOG performance status of 0 or 1 or equivalent for patients of 12-17 years of age * adequate organ function (further defined in protocol) Exclusion Criteria: * known microsatellite instability (MSI)hi disease based on institutional standard * known tumor mutation burden \<1 nonsynonymous mutations/MB Complete list of inclusion and exclusion criteria are listed in the clinical study protocol