First-in-Human Study of STC-1010 Immunotherapy for Advanced or Metastatic Colorectal Cancer

Inclusion Criteria

• Men and women aged 18 to 75 years.
• Diagnosed with advanced colorectal cancer that cannot be surgically removed.
• Previous chemotherapy allowed if it ended more than 6 months before the cancer returned.
• Must have specific genetic tests done (KRAS and BRAF mutations).
• Cancer must be measurable by standard criteria.
• Must agree to have a biopsy if it is safe and possible.
• Must be in good overall health, with a performance status score of 0 or 1.
• Life expectancy of more than 3 months.
• Must use effective birth control methods.

Exclusion Criteria

• Have fluid buildup in the abdomen or around the lungs causing symptoms.
• Have a specific enzyme deficiency (DPD deficiency).
• Have a tumor that can be surgically removed with the intent to cure.
• Have had chemotherapy for metastatic cancer before.
• Have had immunotherapy for advanced cancer before (except for certain study groups).
• Have been treated with an experimental drug before.
• Have a BRAF mutation.
• Have active autoimmune diseases like rheumatoid arthritis or lupus.
• Require medications that suppress the immune system.
• Have had major surgery less than 4 weeks before starting the study treatment.
• Have had radiation therapy less than 4 weeks before starting the study treatment, or less than 2 weeks for palliative care.
• Have had a stem cell or organ transplant.
• Have dementia or mental health issues that prevent understanding the study.
• Have active drug or alcohol abuse.
• Are under legal protection or in psychiatric care for reasons other than research.