Treatment of Cabotamig (ARB202) in Advanced Gastrointestinal Cancer Patients

Exclusion Criteria

• •Prior gene therapy or therapy with any murine monoclonal antibodies or any murine containing product.
• •Concurrent treatment with any anticancer agent including chemotherapy, hormonal therapy or radiation therapy. Must be 5 X half-life or 6 weeks (whichever is shorter) post dosing of previous cancer therapies.
• •History of allergy or hypersensitivity to murine proteins or study product excipients
• •Females who are pregnant, trying to become pregnant, or breastfeeding.
• •Diagnosis of HIV or chronic active viral hepatitis (HBV, HCV, HIV).
• •Active infection requiring systemic treatment.
• •Active brain, leptomeningeal, or paraspinal metastases, except for asymptomatic metastases and are stable on a steroid dose of ≤ 10mg/day of prednisone or its equivalent for at least 14 days prior to the start of study interventions.
• •Impaired cardiac function (AHA NY Heart Association Grade II-IV) or clinically significant cardiac disease.
• •Lack of recovery of prior CTCAE Grade 3 or above adverse events due to earlier therapies.
• •Chronic use of corticosteroids in excess of \>10mg daily of prednisone or equivalent within 4 weeks prior to alopecia.
• •Concomitant use of complementary or alternative medication or therapy such as Chinese herbal medicine.
• •History of Crohn's disease, inflammatory bowel disease, or ulcerative colitis within the past 5 years
• •Abnormal bowel function which would make assessment of bowel permeability difficult to access
• •Major trauma or major surgery within 4 weeks prior to first dose of study drug