A Study of a Personalized Neoantigen Cancer Vaccine

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:

NSCLC who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy (note: patients who have received anti-PD-(L)1 monotherapy are eligible)
GEA who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy
mUC who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy
CRC-MSS who are receiving first line systemic therapy or who are planned for or have received no more than 1 cycle of second line systemic therapy including a fluoropyrimidine and oxaliplatin or irinotecan
18 years of age or older
ECOG Performance Status 0 or 1
Lesion amenable to biopsy
Measurable disease according to RECIST v1.1
Have adequate organ function, as measured by laboratory values (criteria listed in protocol)

Exclusion Criteria:

Tumors with genetic characteristics as follows:

For NSCLC, patients with a known genetic driver alteration in EGFR, ALK, ROS1, RET, or TRK
For CRC and GEA, patients with known MSI-high disease based on institutional standard
For CRC, patients with a known BRAF V600E mutation or patients with peritoneal carcinomatosis and for GEA, patients with peritoneal carcinomatosis as their only evidence of disease
Patients with known central nervous system (CNS) metastases and/or carcinomatous meningitis
Known exposure to chimpanzee adenovirus or any history of anaphylaxis in reaction to a vaccination or allergy or hypersensitivity to study drug components
Bleeding disorder (eg., factor deficiency, coagulopathy) or history of significant bruising or bleeding following IM injections or blood draws

Complete inclusion and exclusion criteria are listed in the clinical study protocol.