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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
ASO-STAT6 exosome administered Intravenously
City of Hope National Medical Center
Duarte, California, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
To characterize the safety and tolerability of CDK-004.
Incidence of treatment-emergent adverse events as assessed by CTCAE 5.0.
Time frame: Up to 2 years
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