Study on the Safety and Effectiveness of PolyPEPI1018 and Atezolizumab in Colorectal Cancer

Inclusion Criteria

• Must be 18 years or older and able to provide written consent.
• Have colorectal cancer that has spread and is confirmed by lab tests.
• Cancer must be microsatellite stable (MSS).
• Have tried 2-3 previous treatments for advanced or metastatic colorectal cancer, including specific chemotherapy drugs and possibly biologics.
• Willing to have a biopsy before and after about 6 weeks of treatment, or provide recent tissue samples.
• Willing to provide a cheek swab for genetic testing.
• Cancer must have shown progression after the last treatment.
• Have measurable cancer as defined by standard criteria.
• Be in good overall health with a performance status of 0 or 1.
• Have adequate organ function based on specific blood tests.
• No major health issues that would prevent participation.
• Women must not be pregnant or breastfeeding and must use effective contraception if of childbearing potential.
• Men must agree to use effective contraception if their partner is of childbearing potential.

Exclusion Criteria

• Have previously received certain types of immunotherapy.
• Have had cancer treatment within 28 days before starting the study treatment.
• Have received a live vaccine within 28 days before starting the study treatment.
• Have had major surgery or significant injury within 28 days before starting the study treatment.
• Are participating in another clinical trial with an investigational product within 21 days before starting the study treatment.
• Have a history of autoimmune diseases, except for controlled hypothyroidism or Type I diabetes.
• Are taking systemic steroids within one week before starting the study treatment, with some exceptions.
• Have a history of severe allergic reactions to vaccines or protein products.
• Have known allergies to the study treatment components.
• Have lung diseases that could interfere with the study.
• Have had a bone marrow or organ transplant.
• Have active brain or spinal cord cancer spread, unless stable and not requiring steroids.
• Have active infections requiring treatment.
• Have significant liver disease.
• Have active HIV, hepatitis B, or hepatitis C infections, unless well-controlled.
• Have other serious health conditions that could increase risk or interfere with the study.
• Are pregnant, breastfeeding, or planning to conceive during the study.
• Have another active cancer requiring treatment within the past two years, except for certain skin or prostate cancers.
• Have substance abuse or other conditions that could interfere with the study.
• Have rapidly progressing disease or a life expectancy of less than three months.