Phase 2 Study of Ivonescimab for Advanced Skin Cancer (cSCC)

Inclusion Criteria

• Must be able to understand and sign a consent form before starting the study.
• Age 18 or older.
• Have advanced skin cancer (cSCC) that cannot be removed by surgery or has spread.
• Cancer has not responded to previous anti-PD-1 therapy.
• Good overall health with a performance status of 0 or 1.
• Have measurable disease according to specific criteria.
• Life expectancy of at least 3 months.
• Adequate organ and bone marrow function based on specific blood test results.
• Must have stopped previous cancer treatments for a certain period before starting the study.
• Blood pressure must be controlled with no more than one medication.
• Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for 120 days after.
• Men must agree to use contraception during the study and for 120 days after.

Exclusion Criteria

• Previous severe reactions to PD-1 inhibitors or need for immunosuppression due to side effects.
• Allergic reactions to similar drugs as ivonescimab.
• Pregnant or breastfeeding women.
• Active autoimmune diseases, except for certain stable conditions.
• Positive test for HIV or history of hepatitis B or C.
• Previous organ or stem cell transplant.
• Active infections requiring IV antibiotics or other serious illnesses needing hospitalization.
• Unresolved side effects from previous treatments, except for certain conditions like stable diabetes or hypothyroidism.
• Major blood vessel invasion or recent major surgery.
• Recent heart problems or severe vascular disease.
• History of severe gastrointestinal issues or bleeding.
• Recent severe lung disease flare-ups.
• Recent treatment with live vaccines.
• Other active cancers needing treatment, except for certain skin or cervical cancers.
• Psychiatric or substance abuse issues affecting study participation.
• Inability to follow study procedures or currently receiving other investigational treatments.