A Study of Personalized Neoantigen Cancer Vaccines

Group 1 Inclusion Criteria: * Provide a signed and dated informed consent form prior to initiation of study-specific procedures * Patients with the indicated advanced or metastatic solid tumor as follows: 1. NSCLC who have received ≤ 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy (Note: patients with NSCLC who are receiving pembrolizumab monotherapy as first line systemic monotherapy are eligible) 2. GEA who have received ≤ 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy 3. mUC who have received ≤ 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy 4. CRC-microsatellite stable (MSS) who have received ≤ 1 cycle of second line systemic therapy including a fluoropyrimidine and oxaliplatin or irinotecan (Note: patients receiving first-line systemic therapy are eligible) * 18 years of age or older * ECOG Performance Status 0 or 1 * Available FFPE tumor specimen for sequencing and neoantigen selection * Measurable disease according to RECIST v1.1 Have adequate organ function, as measured by laboratory values (criteria listed in protocol) Group 1 Exclusion Criteria: * Tumors with genetic characteristics as follows: 1. For NSCLC, patients with a known driver genomic alteration in EGFR, ALK, ROS1, RET, or TRK 2. For CRC or GEA, patients with MSI disease 3. For CRC, patients with a known BRAF mutation or patients with peritoneal carcinomatosis Group 2 Inclusion Criteria: * Provide a signed and dated informed consent form prior to initiation of study-specific procedures * Patient's tumor possesses one of the mutations listed in the clinical study protocol, as determined per local institutional standard * Patients with an advanced or metastatic solid tumor as follows: 1. MSS-CRC who are currently receiving systemic treatment with a fluoropyrimidine and oxaliplatin or irinotecan that may include a VEGF or EGFR targeting therapy as their first-line or second-line therapy for metastatic disease 2. NSCLC who are currently receiving systemic treatment with cytotoxic, platinum-based chemotherapy in combination with an anti-PD-(L)1 antibody 3. PDA who are currently receiving systemic cytotoxic chemotherapy as their first-line therapy for metastatic disease Group 2 Exclusion Criteria * Patients with MSI disease * Patients with NSCLC with a known driver genomic alteration in EGFR, ALK, ROS1, RET, or TRK Complete inclusion and exclusion criteria are listed in the clinical study protocol.