Advanced Hepatocellular Carcinoma (HCC) Clinical Trial
Official title:
Phase 1 Study of Macrophage Reprogramming Agent, exoASO-STAT6 (CDK-004), in Patients With Advanced Hepatocellular Carcinoma (HCC) and Patients With Liver Metastases From Either Primary Gastric Cancer or Colorectal Cancer (CRC)
This is a first-in-human, Phase 1 open-label, multicenter, dose escalation, safety, pharmacodynamic, and PK study of exoASO-STAT6 (CDK-004) in patients with advanced Hepatocellular Carcinoma (HCC) and patients with liver metastases from either primary gastric cancer or colorectal cancer (CRC).
CDK-004 as an intravenous (IV) treatment for advanced hepatocellular carcinoma (HCC), and primary gastric cancer or CRC with secondary liver metastases. CDK-004 is an investigational therapeutic candidate consisting of cell-derived exosomes loaded with a synthetic lipid-tagged oligonucleotide. CDK-004 is designed to allow for specific delivery of the STAT6 anti-sense oligonucleotide (ASO) to the myloid to repolarize macrophage from immune suppressive M2 to proinflammatory M1 phenotype, with a potential for meaningful single agent antitumor activity which has not been observed with other pathway inhibitors to date. CDK-004 will be administered as a single agent intravenously (IV) at various doses. Dose limiting toxicities (DLTs) will be assessed during the study. ;
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