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CDK-004 administered as a single agent intravenously (IV) on Days 1 and 15 of Cycles 1 and 2, on Day 1 of every Cycle.

ASO-STAT6 exosome administered Intravenously

CDK-004

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.

A 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)

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)

Incidence of treatment-emergent adverse events as assessed by CTCAE 5.0.

Codiak BioSciences

Cholangiocarcinoma

Bile Duct Cancer

Intrahepatic Cholangiocarcinoma

Eligible patients will be implanted with a device that combines components of two commercially available drug delivery pumps to administer regional chemotherapy (FUDR) to the liver. Specifically, a Medtronic pump is being used with an Intera tapered catheter, instead of the Medtronic catheter.

This infusion system is composed of a Medtronic SynchroMed II programmable pump connected to a Intera tapered catheter. Specifically, the Medtronic pump comes with a small connector that ends in a metal flange. During the operation, under sterile conditions, the distal 1 cm of the flange is severed using a scissor. Then, using a Intera connector pin, the end of the Medtronic catheter is connected to the Intera catheter . Two 2-0 silk ties secure the catheters to the pin. The pump and catheter are then inserted into the patient into the abdominal wall or into the chest wall. The catheter is inserted into an artery within the abdomen (usually the gastroduodenal artery but it depends on the exact arterial branching in the individual patient) that feeds the liver.

Medtronic SynchroMed II programmable pump connected to an Intera tapered catheter (Combined Infusion System)

Ronald DeMatteo, MD

Allie Raevsky, MS

Danielle R Jaffe, BS/BA

This is a single-site, open-label continued access study/treatment protocol under a treatment IDE. In addition to treating patients, the primary objective of this study is to assess the safety of using the Medtronic SynchroMed II programmable pump combined with the Intera tapered catheter for hepatic artery infusion (HAI) of a standard chemotherapy (FUDR) drug for adults with a clinical or biopsy-proven diagnosis of colorectal cancer metastatic to the liver or intrahepatic cholangiocarcinoma.

After successful implantation, the combined pump and catheter system will be evaluated using a nuclear scan in the postoperative period, which is standard procedure to confirm that the pump is functioning prior to HAI of FUDR. Monitoring for safety will include a record of residual pump volume when it is emptied (every 2-12 weeks depending on whether the pump is being used for chemotherapy infusion) to determine if the pump is still working and surveillance of routine cross-sectional imaging (usually every 2-6 months) for any sign of a pump or catheter problem. Patients will be monitored for the safety of the pump/catheter combination for up to 5 years or pump removal/study withdrawal.

Infusion System for Hepatic Cancer

Combined Infusion System to Deliver Chemotherapy Regionally to the Liver

TAEs are defined as AEs deemed related to the combination of the devices (i.e., the connection between the Medtronic pump and Intera Catheter).

Ronald DeMatteo, M.D.

Chair, Department of Surgery; John Rhea Barton Professor of Surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A 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)	NCT05375604	Advanced Hepato... Gastric Cancer ... Colorectal Canc...	CDK-004	18 Years -	Codiak BioSciences
A 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)	NCT05375604	Advanced Hepato... Gastric Cancer ... Colorectal Canc...	CDK-004	18 Years -	Codiak BioSciences
Infusion System for Hepatic Cancer	NCT04684862	Colorectal Canc... Intrahepatic Ch...	Medtronic Synch...	18 Years -	Abramson Cancer Center at Penn Medicine
Infusion System for Hepatic Cancer	NCT04684862	Colorectal Canc... Intrahepatic Ch...	Medtronic Synch...	18 Years -	Abramson Cancer Center at Penn Medicine

Spots Global Cancer Trial Database for colorectal cancer metastatic to liver