Study on AK112 With or Without AK117 for Treating Metastatic Colorectal Cancer

Inclusion Criteria

• Have a confirmed diagnosis of colorectal cancer.
• For Part 1: Have not received any previous systemic cancer treatment, or if you have had treatment before, your cancer must have returned or spread at least 12 months after your last treatment.
• For Part 2: Have received previous treatments like fluorouracil, oxaliplatin, irinotecan, bevacizumab, or anti-EGFR antibodies, or cannot tolerate or have reasons not to use standard treatments.
• Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have cancer that can be measured using standard criteria.
• Have good blood and organ function based on medical tests.

Exclusion Criteria

• Have a specific type of genetic instability in your cancer known as MSI-H or dMMR.
• Have had previous treatments with immunotherapy, including drugs that target the immune system or immune cell therapies.
• Have a history of autoimmune diseases.
• Have had a stem cell or organ transplant.
• Test positive for HIV or have active hepatitis B or C infections.
• Have received a live vaccine within 30 days before starting the study or during the treatment period.
• Are pregnant or breastfeeding.
• Have difficulty swallowing.