A Phase I Study of CDK-004 Immunotherapy in People with Advanced Liver Cancer


Full 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 Primary Gastric Cancer and Colorectal Cancer (CRC)


The purpose of this study is to find the highest dose of the investigational drug CDK-004 that can be given safely in people with advanced hepatocellular carcinoma (the most common type of liver cancer). CDK-004 is a form of immunotherapy that is designed to reduce levels of certain cells that block the immune system’s ability to recognize cancer cells. Once the immune system is able to detect cancer cells, it can attack and possibly destroy them. CDK-004 is given intravenously (by vein).


To be eligible for this study, patients must meet several requirements, including:

  • Participants must have advanced hepatocellular carcinoma that has continued to grow despite treatment with atezolizumab plus bevacizumab, lenvatinib, or sorafenib.
  • At least 3 weeks must pass between the completion of treatment and receipt of CDK-004.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.


For more information and to ask about eligibility for this study, please contact the office of Dr. James Harding at 646-888-4314.





Disease Status

Relapsed or Refractory