Phase 2 Study of SR-8541A with Botensilimab and Balstilimab for Treating Advanced Colorectal Cancer

Inclusion Criteria

• Must provide written consent to participate.
• Be 18 years or older.
• Have a confirmed diagnosis of advanced colorectal cancer that cannot be surgically removed.
• Have a specific type of tumor that is not high in microsatellite instability.
• Have received at least one prior chemotherapy treatment for advanced colorectal cancer.
• Be in good general health with an ECOG performance status of 0 or 1.
• Have measurable cancer according to specific criteria.
• Be able to provide a tumor sample before starting treatment.
• Have good kidney, liver, and blood function.
• Not have received certain supportive treatments within 14 days before starting the study.
• Be willing to follow the study schedule and procedures.
• Use effective birth control during the study and for three months after the last treatment if of childbearing potential.

Exclusion Criteria

• Allergic to any of the study drugs.
• Have active liver metastases in certain parts of the study.
• Have taken certain medications within a specified time before starting the study.
• Have received certain immune therapies before.
• Have had bowel obstruction recently or signs of it.
• Have fluid buildup in the abdomen that is not responding to treatment.
• Have lung disease or inflammation.
• Be on high doses of steroids or other immune-suppressing drugs recently.
• Have an active autoimmune disease needing treatment in the past two years.
• Have certain heart conditions or recent heart events.
• Have had an organ or stem cell transplant.
• Have had a recent COVID-19 infection.
• Need certain medications that affect drug metabolism.
• Have a condition affecting drug absorption.
• Have high levels of certain heart markers or uncontrolled high blood pressure.
• Have certain heart rhythm issues.
• Have uncontrolled brain disease or recent brain treatment.
• Have bleeding disorders or are on blood thinners that can't be stopped.
• Have another progressing cancer or recent cancer treatment.
• Have uncontrolled seizures or mental health issues affecting study participation.
• Have an active infection needing treatment.
• Test positive for HIV or active hepatitis B or C.
• Be pregnant or breastfeeding.
• Have had major surgery recently.
• Have any other significant health issues that could affect safety or study results.
• Plan to use medications not allowed in the study.