A Phase 1, First-in-human Study of Cabotamig (ARB202), Bispecific Antibody to CDH17 and CD3 in Advanced Gastrointestinal Malignancies
This study aims to find out: 1. The tolerability of Cabotamig (ARB202) in adults with advanced solid gastrointestinal tumors who failed the standard treatment. People can participate if their tumor has the CDH17 marker. 2. To find out how study drug is broken down in the body 3. To know the effects of the study drug on the tumor.
• Histologically confirmed colorectal, pancreatic, gastric adenocarcinoma, primary liver cancer 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. If the testing is based on fine-needle aspiration (FNA) biopsy, the patient will be considered eligible when tumor aspirate demonstrates detectable positive staining cells for CDH17.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
• Life expectancy \> 3 months.
• Measurable disease as defined by RECIST 1.1 criteria
• Blood coagulation parameters:
‣ PT INR ≤ 1.5X ULN
⁃ PTT INR ≤1.2X ULN
• Patients must have adequate venous peripheral access for apheresis.
• Satisfactory organ and bone marrow function as defined by:
‣ absolute neutrophil count \> 1,000/μL
⁃ platelets \>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