Brief Summary
This study aims to find out:
- The tolerability of Cabotamig (ARB202) in adults with advancedat a late stage, far along solid gastrointestinal tumors who failed the standard treatment. People can participate if their tumor has the CDH17 marker.
- To find out how study drug is broken down in the body
- To know the effects of the study drug on the tumor.
Intervention / Treatment
- Drug: Cabotamig (ARB202)
Inclusion Criteria
- Histologically confirmed colorectalrelating to the colon or rectum in the large bowel/intestine, pancreatic, gastric adenocarcinomacancer arising from mucus-producing glands in organs, primary liver cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs or metastatic liver disease, or cholangiocarcinoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- Malignancies should possess with ≥10% expression of CDH17 confirmed by immunohistochemistry except for CRC patients.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of ≤2.
- Life expectancy > 3 months.
- Measurable disease as defined by RECIST 1.1 criteria
- Bloodthe red bodily fluid that transports oxygen and other nutrients around the body coagulation parameters:
- PT INR ≤ 1.5X ULN
- PTT INR ≤1.2X ULN
- Patients must have adequate venous peripheral access for apheresisa medical procedure where a machine separates a particular blood compnent from the blood and then returns the rest to the body.
- Satisfactory organ and bone marrowsoft, spongy tissue found in bones that makes blood cells function as defined by:
- absolute neutrophil count > 1,000/μL
- plateletssmall disc-shaped blood cells that clump together to form clots to stop bleeding >100,000/μL
- hemoglobin ≥9 g/dL
- serum ALT and AST ≤ 3X ULN or AST and ALT ≤5X ULN, if liver function abnormalities are thought to be from underlying malignancy
- total serum bilirubin ≤ 2X ULN
- Creatinine <1.5X ULN
- Stable amylase for 2 weeks