Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors

Inclusion criteria

• ✓. Have the ability to comprehend and willingness to provide written informed consent (ICF) for the study.
• ✓. Have previously proven microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status (confirmatory testing is not required);
• ✓. Patients with locally advanced unresectable or metastatic, microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) CRC who are eligible for anti-PD-1 1st line of treatment. Patients may have received prior adjuvant chemotherapy for CRC as long as it was completed at least 6 months prior to Study Day 1 .
• ✓. Be ≥18 years of age on day of signing informed consent.
• ✓. Have a life expectancy of at least 6 months.
• ✓. Have a performance status of 0 - 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
• ✓. Have resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 2 or less (except alopecia). If subject received major surgery or radiation therapy they must have recovered from the toxicity and/or complications from the intervention.
• ✓. Have adequate organ function as defined in the following tables (Table 1. Adequate Organ Function Laboratory Values ). Specimens must be collected within 10 days prior to the start of study treatment. If any hematological or chemistry values are outside the specified range during the initial screening, rescreening process may be conducted to reassess and ensure compliance with the adequate organ function criteria as outlined in Table 1.