A Study of a Personalized Cancer Vaccine Targeting Shared Neoantigens

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. Microsatellite-stable colorectal cancer (MSS-CRC) who are currently receiving systemic treatment with a fluoropyrimidine and oxaliplatin and/or irinotecan that may include a VEGF or EGFR targeting therapy as their 1L therapy for metastatic disease OR who have experienced disease progression following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan that may include a VEGF or EGFR targeting therapy and have not received additional lines of systemic therapy in the metastatic setting.
• •2. Non-small cell lung cancer (NSCLC) who are currently receiving systemic treatment with an anti-PD-(L)1 antibody in combination with cytotoxic, platinum-based chemotherapy OR who have experienced disease progression following treatment with an anti-PD-(L)1 antibody in combination with cytotoxic, platinum-based chemotherapy (or anti-PD-(L)1 alone if patient refuses platinum-based chemotherapy), and have not received additional lines of systemic therapy in the metastatic setting.
• •3. Pancreatic ductal adenocarcinoma (PDA) who are currently receiving systemic cytotoxic chemotherapy as their 1L therapy for metastatic disease OR who have experienced disease progression on 1L systemic cytotoxic chemotherapy and have received no more than 1 prior line of therapy in the metastatic setting.
• •4. Any solid tumor histology where the patient has experienced disease progression with all available therapies known to confer clinical benefit
• •Patient's tumor possesses one of the mutations listed below, and is determined to express a HLA allele for antigen presentation of the identified tumor mutation:
• •VERSION 1.0 of the expression cassette:
• •BRAF\_G466V // CTNNB1\_S37F // CTNNB1\_S45F // CTNNB1\_S45P // CTNNB1\_T41A // ERBB2\_Y772\_A775dup // KRAS\_G12C or NRAS\_G12C // KRAS\_G12D or NRAS\_G12D // KRAS\_G12V // KRAS\_G13D // KRAS\_Q61H or NRAS\_Q61H // KRAS\_Q61K or NRAS\_Q61K // KRAS\_Q61L or NRAS\_Q61L // KRAS\_Q61R or NRAS\_Q61R // TP53\_K132E // TP53\_K132N // TP53\_R213L // TP53\_R249M // TP53\_S127Y
• •VERSION 2.0 of the expression cassette:
• •KRAS\_G12C or NRAS\_G12C // KRAS\_G12D or NRAS\_G12D // KRAS\_G12V or NRAS\_G12V // KRAS\_Q61H or NRAS\_Q61H
• •ECOG Performance Status 0 or 1
• •Measurable disease according to RECIST v1.1
• •Adequate organ function, as measured by laboratory values (criteria listed in protocol)