A Clinical Trial Evaluating the Safety and Efficacy of Intravenous HNF4α SrRNA in Treating Metastatic CRC Patients

This study will administer HNF4α srRNA via intravenous injection to treat locally unresectable or metastatic colorectal cancer. The second treatment will be conducted 14 ± 3 days after the initial treatment, with subsequent treatment cycles every 28 ± 7 days (the dosing interval will be adjusted based on the tolerability, safety, and therapeutic effect of the subjects). The dose-escalation trial will employ the i3+3 design method, with three dose groups, tentatively setting the injection dose of HNF4α srRNA at 25 μg, 50 μg, and 100 μg per administration, and each group is expected to include up to 3 subjects. According to Amendment 1, after enrollment, the investigator will determine the HNF4α srRNA dose, whether to combine it with immunotherapy, and the dose and schedule of the combination, based on the patient's treatment history and the safety/efficacy data of HNF4α srRNA (CD-801/CD-GA-102) administered via peripheral vein for hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), or colorectal cancer (CRC). Participants initially on HNF4α srRNA monotherapy who are considered for combination with immunotherapy must complete at least two treatment cycles and the post - treatment safety assessment. Then, the investigator can decide whether to add immunotherapy after a comprehensive review of their treatment history.